WO2022223134A1 - Implant fixture for early detection of pathological states of peri-implantitis or peri-implant mucositis - Google Patents
Implant fixture for early detection of pathological states of peri-implantitis or peri-implant mucositis Download PDFInfo
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- WO2022223134A1 WO2022223134A1 PCT/EP2021/064653 EP2021064653W WO2022223134A1 WO 2022223134 A1 WO2022223134 A1 WO 2022223134A1 EP 2021064653 W EP2021064653 W EP 2021064653W WO 2022223134 A1 WO2022223134 A1 WO 2022223134A1
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- implant
- implant fixture
- peri
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- opening
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Links
- 239000007943 implant Substances 0.000 title claims abstract description 75
- 208000006389 Peri-Implantitis Diseases 0.000 title claims description 11
- 206010028116 Mucosal inflammation Diseases 0.000 title claims description 6
- 201000010927 Mucositis Diseases 0.000 title claims description 6
- 230000001575 pathological effect Effects 0.000 title claims description 5
- 238000001514 detection method Methods 0.000 title description 2
- 239000012530 fluid Substances 0.000 claims abstract description 19
- 210000000988 bone and bone Anatomy 0.000 claims abstract description 15
- 238000004040 coloring Methods 0.000 claims abstract description 12
- 230000004054 inflammatory process Effects 0.000 claims abstract description 9
- 239000000126 substance Substances 0.000 claims abstract description 9
- 206010061218 Inflammation Diseases 0.000 claims abstract description 8
- 150000001875 compounds Chemical class 0.000 claims abstract description 8
- 210000004195 gingiva Anatomy 0.000 claims abstract description 3
- 235000012732 erythrosine Nutrition 0.000 claims description 8
- 239000004174 erythrosine Substances 0.000 claims description 8
- 229920002101 Chitin Polymers 0.000 claims description 5
- IINNWAYUJNWZRM-UHFFFAOYSA-L erythrosin B Chemical compound [Na+].[Na+].[O-]C(=O)C1=CC=CC=C1C1=C2C=C(I)C(=O)C(I)=C2OC2=C(I)C([O-])=C(I)C=C21 IINNWAYUJNWZRM-UHFFFAOYSA-L 0.000 claims description 5
- 229940011411 erythrosine Drugs 0.000 claims description 5
- 239000000022 bacteriostatic agent Substances 0.000 claims description 3
- 230000003115 biocidal effect Effects 0.000 claims description 3
- 239000003102 growth factor Substances 0.000 claims description 3
- 230000002188 osteogenic effect Effects 0.000 claims description 3
- 229950003937 tolonium Drugs 0.000 claims description 3
- HNONEKILPDHFOL-UHFFFAOYSA-M tolonium chloride Chemical compound [Cl-].C1=C(C)C(N)=CC2=[S+]C3=CC(N(C)C)=CC=C3N=C21 HNONEKILPDHFOL-UHFFFAOYSA-M 0.000 claims description 3
- 238000004891 communication Methods 0.000 claims description 2
- 230000000593 degrading effect Effects 0.000 claims description 2
- -1 carrier Chemical class 0.000 claims 2
- 230000001580 bacterial effect Effects 0.000 description 9
- 238000000034 method Methods 0.000 description 8
- 210000000214 mouth Anatomy 0.000 description 6
- 102000016943 Muramidase Human genes 0.000 description 5
- 108010014251 Muramidase Proteins 0.000 description 5
- 108010062010 N-Acetylmuramoyl-L-alanine Amidase Proteins 0.000 description 5
- 230000009471 action Effects 0.000 description 5
- 238000011109 contamination Methods 0.000 description 5
- 229960000274 lysozyme Drugs 0.000 description 5
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- 210000001519 tissue Anatomy 0.000 description 5
- 230000008569 process Effects 0.000 description 4
- 239000003642 reactive oxygen metabolite Substances 0.000 description 4
- 230000001225 therapeutic effect Effects 0.000 description 4
- 238000013459 approach Methods 0.000 description 3
- 239000011248 coating agent Substances 0.000 description 3
- 238000000576 coating method Methods 0.000 description 3
- 208000015181 infectious disease Diseases 0.000 description 3
- 230000002757 inflammatory effect Effects 0.000 description 3
- 238000001356 surgical procedure Methods 0.000 description 3
- 238000002560 therapeutic procedure Methods 0.000 description 3
- 239000000654 additive Substances 0.000 description 2
- 230000000996 additive effect Effects 0.000 description 2
- 239000003242 anti bacterial agent Substances 0.000 description 2
- 230000000844 anti-bacterial effect Effects 0.000 description 2
- 230000003385 bacteriostatic effect Effects 0.000 description 2
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- 238000012512 characterization method Methods 0.000 description 2
- 239000003795 chemical substances by application Substances 0.000 description 2
- 239000003086 colorant Substances 0.000 description 2
- 239000004053 dental implant Substances 0.000 description 2
- 230000001419 dependent effect Effects 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 238000007306 functionalization reaction Methods 0.000 description 2
- 150000004676 glycans Chemical class 0.000 description 2
- 230000028993 immune response Effects 0.000 description 2
- 238000011065 in-situ storage Methods 0.000 description 2
- 230000003902 lesion Effects 0.000 description 2
- 230000000010 osteolytic effect Effects 0.000 description 2
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- 229920001282 polysaccharide Polymers 0.000 description 2
- 239000005017 polysaccharide Substances 0.000 description 2
- 241000894007 species Species 0.000 description 2
- 208000002679 Alveolar Bone Loss Diseases 0.000 description 1
- 208000034309 Bacterial disease carrier Diseases 0.000 description 1
- 208000035143 Bacterial infection Diseases 0.000 description 1
- 102000012286 Chitinases Human genes 0.000 description 1
- 108010022172 Chitinases Proteins 0.000 description 1
- 208000035473 Communicable disease Diseases 0.000 description 1
- 241000238424 Crustacea Species 0.000 description 1
- 208000002064 Dental Plaque Diseases 0.000 description 1
- 208000037408 Device failure Diseases 0.000 description 1
- QXNVGIXVLWOKEQ-UHFFFAOYSA-N Disodium Chemical class [Na][Na] QXNVGIXVLWOKEQ-UHFFFAOYSA-N 0.000 description 1
- 241000233866 Fungi Species 0.000 description 1
- 241000238631 Hexapoda Species 0.000 description 1
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- OVRNDRQMDRJTHS-FMDGEEDCSA-N N-acetyl-beta-D-glucosamine Chemical group CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O OVRNDRQMDRJTHS-FMDGEEDCSA-N 0.000 description 1
- 208000037273 Pathologic Processes Diseases 0.000 description 1
- 206010072574 Periodontal inflammation Diseases 0.000 description 1
- 102000014128 RANK Ligand Human genes 0.000 description 1
- 108010025832 RANK Ligand Proteins 0.000 description 1
- 240000004808 Saccharomyces cerevisiae Species 0.000 description 1
- 238000009825 accumulation Methods 0.000 description 1
- 230000002053 acidogenic effect Effects 0.000 description 1
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- 210000003484 anatomy Anatomy 0.000 description 1
- 229940088710 antibiotic agent Drugs 0.000 description 1
- 239000003963 antioxidant agent Substances 0.000 description 1
- 208000022362 bacterial infectious disease Diseases 0.000 description 1
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- 230000008236 biological pathway Effects 0.000 description 1
- 210000002421 cell wall Anatomy 0.000 description 1
- 239000011247 coating layer Substances 0.000 description 1
- 238000010276 construction Methods 0.000 description 1
- 238000012937 correction Methods 0.000 description 1
- 230000006378 damage Effects 0.000 description 1
- 238000005202 decontamination Methods 0.000 description 1
- 230000003588 decontaminative effect Effects 0.000 description 1
- 238000013461 design Methods 0.000 description 1
- 230000001066 destructive effect Effects 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 238000000605 extraction Methods 0.000 description 1
- 235000013373 food additive Nutrition 0.000 description 1
- 239000002778 food additive Substances 0.000 description 1
- 239000000576 food coloring agent Substances 0.000 description 1
- 210000001035 gastrointestinal tract Anatomy 0.000 description 1
- 230000036541 health Effects 0.000 description 1
- 230000002458 infectious effect Effects 0.000 description 1
- 210000004969 inflammatory cell Anatomy 0.000 description 1
- 238000003780 insertion Methods 0.000 description 1
- 230000037431 insertion Effects 0.000 description 1
- 231100000053 low toxicity Toxicity 0.000 description 1
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- 230000000813 microbial effect Effects 0.000 description 1
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- 230000009054 pathological process Effects 0.000 description 1
- 201000001245 periodontitis Diseases 0.000 description 1
- 230000000770 proinflammatory effect Effects 0.000 description 1
- 238000002271 resection Methods 0.000 description 1
- 210000003296 saliva Anatomy 0.000 description 1
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
- A61C19/00—Dental auxiliary appliances
- A61C19/06—Implements for therapeutic treatment
- A61C19/063—Medicament applicators for teeth or gums, e.g. treatment with fluorides
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/0059—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
- A61B5/0082—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence adapted for particular medical purposes
- A61B5/0088—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence adapted for particular medical purposes for oral or dental tissue
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/45—For evaluating or diagnosing the musculoskeletal system or teeth
- A61B5/4538—Evaluating a particular part of the muscoloskeletal system or a particular medical condition
- A61B5/4542—Evaluating the mouth, e.g. the jaw
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/48—Other medical applications
- A61B5/4851—Prosthesis assessment or monitoring
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
- A61C8/00—Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools
- A61C8/0018—Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools characterised by the shape
- A61C8/0037—Details of the shape
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
- A61C8/00—Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools
- A61C8/0003—Not used, see subgroups
- A61C8/0004—Consolidating natural teeth
- A61C8/0006—Periodontal tissue or bone regeneration
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
- A61C8/00—Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools
- A61C8/0012—Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools characterised by the material or composition, e.g. ceramics, surface layer, metal alloy
- A61C8/0013—Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools characterised by the material or composition, e.g. ceramics, surface layer, metal alloy with a surface layer, coating
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
- A61C8/00—Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools
- A61C8/0093—Features of implants not otherwise provided for
Definitions
- the present invention refers to an implant fixture suitable for detecting pathological states of peri-implantitis or peri-implant mucositis early, by coloring inside the mouth, for example the tongue or a gum, in correspondence with the implant fixture itself, so as to allow a timely medical intervention on the patient.
- a dental implant is a medical-surgical device, inserted into the maxillary and/or mandibular bone, which acts as a support for a prosthetic replacement of the teeth. It is used to functionally and aesthetically rehabilitate the loss or lack of one or more teeth.
- Dental implant failures are usually due to biophysical and biomechanical biological problems occurring simultaneously. Biological-based failures are mostly associated with the accumulation of microbial plaque and bacterial infections, generally hesitating such as peri-implantitis, in which implant design plays an important role.
- Peri-implant lesions show a well-defined biological organization, not only in terms of inflammatory cells, but also with respect to biological and biochemical components: in particular, the presence of reactive oxygen species (ROS) has been linked to the inflammatory environment peri-implant that affects the correct clinical course of the infectious disease that can affect the health and survival of the implants. Indeed, peri-implantitis appears to be linked to an increase in the production of reactive oxygen species (ROS), which are closely related, in turn, to inflammation. Other recent studies have shown an association between oxidative stress and periodontal inflammation leading to alveolar bone loss and periodontitis.
- ROS reactive oxygen species
- an appropriate approach would be to treat peri-implantitis with antioxidant agents that reduce the activity of RANKL-related osteoclasts, to prevent/reduce/treat peri- implantitis lesions at different stages.
- the implant can fail due to microbiological variables, especially bacterial, depending on the peri-implant environment, the implant surface in contact with biological tissues, the patient and his immunological/biological response, the operator and his pre-procedures./intra/post-implant surgery.
- the actions that can be carried out are:
- the implant can also fail due to physicochemical variables, in particular relating to the variation in pH typically triggered by the contamination of acidogenic and acidophilic bacterial species which in turn trigger pro-inflammatory and osteolytic biological pathways, dependent on the peri-implant environment, implant surface in contact with biological tissues, from the patient and his immunological/biological response, from the operator and his pre/intra/post-implant surgery procedures: on these variables it is possible to implement corrections deriving from the inventive step described here .
- physicochemical variables in particular relating to the variation in pH typically triggered by the contamination of acidogenic and acidophilic bacterial species which in turn trigger pro-inflammatory and osteolytic biological pathways, dependent on the peri-implant environment, implant surface in contact with biological tissues, from the patient and his immunological/biological response, from the operator and his pre/intra/post-implant surgery procedures: on these variables it is possible to implement corrections deriving from the inventive step described here .
- a first drawback of said corrective actions consists in the fact that the wash-out of the local therapy is rapid; effectiveness depends on proper therapeutic planning and requires numerous follow-ups. Furthermore, the application of this therapy depends on the objective clinical manifestation of peri-implantitis, therefore the presence of a doctor would be required to object to the pathological process in progress.
- a second drawback consists in the fact that the textures can act on some bacterial species, consistent with the steric hindrance between the bacterial morphology and the trabeculae of the texture.
- the creation of a first form of bacterial aggregation (envelope) around the functionalized implant would in any case create a valid substrate for the creation of growth not in direct contact with the implant but in any case in the peri-implant sulcus, creating indirect damage inflammatory type.
- a third drawback consists in the fact that the wash-out of the local coating layer is rapid, which can only be used for a short period following implant insertion (slow-releasing), the effectiveness depending on the correct characterization of the type of therapeutic approach site-specific of the coating and in any case does not protect against any infectious processes in the following post-surgery months.
- Object of the present invention is to at least partially overcome the drawbacks complained of through the use of an implant fixture, in accordance with claim 1, capable of detecting autonomously and early on the onset of pathological states compatible with peri-implant mucositis, which can evolve in early stages of peri-implantitis, in order to allow prompt medical intervention on the patient.
- Said implant fixture which is inserted in the maxillary and/or mandibular bone, is characterized in that it provides an internal cavity, put in communication with the outside through at least one opening, in which:
- said internal cavity is filled with a highly coloring biocompatible fluid;
- said at least one opening is kept inaccessible due to the presence of a chemical compound (carrier) that can be attacked by one or more components present in the crevicular and/or salivary fluid; in such a way that, following a retraction of the gingiva following an inflammation and loss of peri-implant bone substance, even of a few millimeters, said crevicular and/or salivary fluid comes into contact with the implant fixture in correspondence with said at least one opening , due to the loss of bone in which said implant fixture is inserted, said chemical compound degrading and allowing the dye fluid to escape which will cause the coloring inside the mouth, for example the tongue or a gum, in correspondence with the fixture and the entire oral cavity, highlighting the presence of said inflammation and loss of peri-implant bone substance.
- a chemical compound carrier
- the implant fixture according to the invention will provide a first treatment of the infection in progress.
- the present invention solves the above drawbacks since the "release in situ" of said coloring fluid will create in the patient a "clear, intelligible and unavoidable” perception that something is happening to his or her oral cavity, creating the urgent conditions for a request for dental visit.
- FIG. 1 are three views of a first embodiment of the implant fixture according to the present invention
- FIG. 2 are three views of a second embodiment of the implant fixture according to the present invention
- FIG. 3 shows the structural formula of a chemical compound (chitin) used in the construction of the implant fixture according to the invention.
- (1) designates an implant fixture, in which a first (2), a second (3) and a third (4) circumferential cavity are identified, for example with annular morphology.
- the first circumferential cavity (2) is placed in the upper part, at a distance of 3 ⁇ 5 mm from the upper edge of the implant fixture (1).
- the second circumferential cavity (3) is placed lower, at a distance of 5 ⁇ 7 mm from the upper edge of the implant fixture (1).
- the third circumferential cavity (4) is placed even lower, at a distance> 5 mm from the lower edge of the implant fixture (1).
- the implant fixture (1) is provided with only the first (2) and second (3) circumferential cavities.
- the implant fixture (1) is provided with only the first circumferential cavity (2).
- Said circumferential cavities (2, 3, 4) are connected with a cavity (5) obtained inside the implant fixture (1) through one or more openings (2a, 3a, 4a), for example four for each of the circumferential cavities (2, 3, 4).
- an implant fixture (10), shown in FIG. 2 (a, b, c), is devoid of circumferential cavities (2, 3, 4), while there is at least one of the openings that connect the internal cavity (5) with the outside.
- the openings (2a) and (4a) are present, corresponding to the circumferential cavities (2) and (4).
- Chitin is a natural polysaccharide formed by N-Acetyl-D- glucosamine residues linked by b1-4 bond. It constitutes the exoskeleton of crustaceans and insects and the cell wall of fungi and yeasts. It is insoluble in most organic solvents and this characteristic makes its use as it is and its chemical-physical characterization very difficult. It has low toxicity and is inert in the gastrointestinal tract of mammals.
- Chitin is only degradable by chitinase, lysozyme and ptyalin. Lysozyme and ptyalin are typically present in fluids that cover anatomical areas (e.g. tears, saliva, crevicular fluid). In the case of the peri-implant sulcus, it has the presence of lysozyme and ptyalin only in the region of the implant neck. The more the collar is exposed as a result of inflammation and loss of bone substance, the greater the area of the implant surface will be exposed to the action of crevicular fluid and therefore of lysozyme.
- a coloring agent for example erythrosine or toluidine blue.
- Erythrosine otherwise called E127 in the European coding of food additives, is an intense red food coloring, which belongs to the chemical class of organoiodides, in particular it is the disodium salt of 2,4,5,7-tetraiodiofluorescein.
- Erythrosine E127 is also commonly used as a dental plaque detecting agent.
- the crevicular fluid and therefore the lysozyme, would come into contact with the carrier, attacking it chemically and the coloring agent contained in the reservoir (5) would come out of the openings (2a , 3a, 4a) and would cause staining inside the mouth, such as the tongue or a gum.
- E127 The "in situ release" of E127 will create in the patient a "clear, intelligible and unavoidable” perception that something is happening to their oral cavity, creating the urgent conditions for a request for a dental visit.
- the simple coloring released by the carrier ring has a diagnostic effect (the release of the dye that "alerts" the patient) and therapeutic (the release of antibiotic and other site-specific therapeutic factors).
- any dye such as toluidine blue, could be used.
- bacteriostatic, pro-osteogenic growth factors or other bioactive substances can be used.
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Dentistry (AREA)
- Biophysics (AREA)
- Medical Informatics (AREA)
- Surgery (AREA)
- Physics & Mathematics (AREA)
- Molecular Biology (AREA)
- Pathology (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Epidemiology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Transplantation (AREA)
- Audiology, Speech & Language Pathology (AREA)
- Physical Education & Sports Medicine (AREA)
- Rheumatology (AREA)
- Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
- Investigating Or Analysing Biological Materials (AREA)
- Prostheses (AREA)
Abstract
An implant fixture (1, 10) inserted in the maxillary and/or mandibular bone is described, having an internal cavity (5), communicated with the outside through an opening (2a, 3a, 4a), wherein: the internal cavity (5) is filled with a coloring fluid; the opening (2a, 3a, 4a) is kept inaccessible due to the presence of a chemical compound (carrier) that can be attacked by one or more components present in the crevicular and/or salivary fluid; in such a way that, following a retraction of the gingiva, resulting from an inflammation and loss of peri-implant bone substance, even of a few millimeters, the crevicular and/or salivary fluid comes into contact with the implant fixture (1, 10) in correspondence of the opening (2a, 3a, 4a), due to the loss of bone in which the implant fixture (1, 10) is inserted.
Description
IMPLANT FIXTURE FOR EARLY DETECTION OF PATHOLOGICAL STATES OF PERI-IMPLANTITIS OR PERI-
IMPLANT MUCOSITIS
The present invention refers to an implant fixture suitable for detecting pathological states of peri-implantitis or peri-implant mucositis early, by coloring inside the mouth, for example the tongue or a gum, in correspondence with the implant fixture itself, so as to allow a timely medical intervention on the patient.
A dental implant is a medical-surgical device, inserted into the maxillary and/or mandibular bone, which acts as a support for a prosthetic replacement of the teeth. It is used to functionally and aesthetically rehabilitate the loss or lack of one or more teeth.
Dental implant failures are usually due to biophysical and biomechanical biological problems occurring simultaneously. Biological-based failures are mostly associated with the accumulation of microbial plaque and bacterial infections,
generally hesitating such as peri-implantitis, in which implant design plays an important role.
When signs of peri-implantitis or peri-implant mucositis occur, medical therapies may not be sufficient or early In this case it is necessary to resort to surgical therapies, which involve resection of the affected tissues, extraction and decontamination of the endosseous implant structure, followed by a bone graft, where a lot of healthy tissue has been lost, applying new implants made with materials that they can enhance the processes of osseointegration with the host tissue and, at the same time, prevent or suppress bacterial colonization.
At present, an approach that clearly leads to complete clinical success in the treatment of peri-implant diseases is not known. Peri-implant lesions show a well-defined biological organization, not only in terms of inflammatory cells, but also with respect to biological and biochemical components: in particular, the presence of reactive oxygen species (ROS) has been linked to the inflammatory environment peri-implant that affects the correct clinical course of the infectious disease that can affect the health
and survival of the implants. Indeed, peri-implantitis appears to be linked to an increase in the production of reactive oxygen species (ROS), which are closely related, in turn, to inflammation. Other recent studies have shown an association between oxidative stress and periodontal inflammation leading to alveolar bone loss and periodontitis. In this context, an appropriate approach would be to treat peri-implantitis with antioxidant agents that reduce the activity of RANKL-related osteoclasts, to prevent/reduce/treat peri- implantitis lesions at different stages. The implant can fail due to microbiological variables, especially bacterial, depending on the peri-implant environment, the implant surface in contact with biological tissues, the patient and his immunological/biological response, the operator and his pre-procedures./intra/post-implant surgery. Currently the actions that can be carried out are:
- trans-tissue delivery of antibacterial/bacteriostatic agents;
- functionalization (by subtraction) of the implant surfaces with variation of the surface texture in order to make it less susceptible to bacterial contamination; - additive (by addition-surface coating that can be conveyed
with numerous techniques) of the implant surfaces with variation of the surface texture in order to make it less attackable by bacterial contamination.
The implant can also fail due to physicochemical variables, in particular relating to the variation in pH typically triggered by the contamination of acidogenic and acidophilic bacterial species which in turn trigger pro-inflammatory and osteolytic biological pathways, dependent on the peri-implant environment, implant surface in contact with biological tissues, from the patient and his immunological/biological response, from the operator and his pre/intra/post-implant surgery procedures: on these variables it is possible to implement corrections deriving from the inventive step described here .
In this second case, the actions currently available are: - trans-tissue delivery of antibacterial/bacteriostatic and basic
PH agents in order to counteract the destructive action accompanying the inflammatory process;
- functionalization (by subtraction) of the implant surfaces with variation of the surface texture in order to make it less attackable by bacterial contamination,
- additive (by addition-surface coating that can be conveyed with numerous techniques) of the implant surfaces with variation of the surface texture in order to make it less attackable by bacterial contamination. However, these corrective actions have some drawbacks.
A first drawback of said corrective actions consists in the fact that the wash-out of the local therapy is rapid; effectiveness depends on proper therapeutic planning and requires numerous follow-ups. Furthermore, the application of this therapy depends on the objective clinical manifestation of peri-implantitis, therefore the presence of a doctor would be required to object to the pathological process in progress.
A second drawback consists in the fact that the textures can act on some bacterial species, consistent with the steric hindrance between the bacterial morphology and the trabeculae of the texture. The creation of a first form of bacterial aggregation (envelope) around the functionalized implant would in any case create a valid substrate for the creation of growth not in direct contact with the implant but in any case in the peri-implant sulcus, creating indirect damage inflammatory type.
A third drawback consists in the fact that the wash-out of the local coating layer is rapid, which can only be used for a short period following implant insertion (slow-releasing), the effectiveness depending on the correct characterization of the type of therapeutic approach site-specific of the coating and in any case does not protect against any infectious processes in the following post-surgery months.
Object of the present invention is to at least partially overcome the drawbacks complained of through the use of an implant fixture, in accordance with claim 1, capable of detecting autonomously and early on the onset of pathological states compatible with peri-implant mucositis, which can evolve in early stages of peri-implantitis, in order to allow prompt medical intervention on the patient. Said implant fixture, which is inserted in the maxillary and/or mandibular bone, is characterized in that it provides an internal cavity, put in communication with the outside through at least one opening, in which:
- said internal cavity is filled with a highly coloring biocompatible fluid;
- said at least one opening is kept inaccessible due to the presence of a chemical compound (carrier) that can be attacked by one or more components present in the crevicular and/or salivary fluid; in such a way that, following a retraction of the gingiva following an inflammation and loss of peri-implant bone substance, even of a few millimeters, said crevicular and/or salivary fluid comes into contact with the implant fixture in correspondence with said at least one opening , due to the loss of bone in which said implant fixture is inserted, said chemical compound degrading and allowing the dye fluid to escape which will cause the coloring inside the mouth, for example the tongue or a gum, in correspondence with the fixture and the entire oral cavity, highlighting the presence of said inflammation and loss of peri-implant bone substance.
If antibiotic and/or bacteriostatic substances and/or pro- osteogenic growth factors are present in the coloring fluid, the implant fixture according to the invention will provide a first treatment of the infection in progress.
Preferred embodiments and non-trivial variants of the present invention form the subject of the dependent claims.
It is understood that all attached claims form an integral part
of the present description.
The present invention solves the above drawbacks since the "release in situ" of said coloring fluid will create in the patient a "clear, intelligible and unavoidable" perception that something is happening to his or her oral cavity, creating the urgent conditions for a request for dental visit.
By alerting the patient, he will have full awareness of usually sub-clinical processes that become evident only after months and in any case when the inflammatory and osteolytic process is already severe.
It will be immediately obvious that innumerable variations and modifications (for example relating to shape, dimensions, arrangements and parts with equivalent functionality) can be made to what is described, without departing from the scope of the invention, as appears from the attached claims.
The present invention will be better described by some preferred embodiments, provided by way of non-limiting example, with reference to the attached drawings, in which:
- FIG. 1 (a, b, c) are three views of a first embodiment of the implant fixture according to the present invention;
- FIG. 2 (a, b, c) are three views of a second embodiment of the implant fixture according to the present invention;
- FIG. 3 shows the structural formula of a chemical compound (chitin) used in the construction of the implant fixture according to the invention.
With reference to FIG. 1 (a, b, c), (1) designates an implant fixture, in which a first (2), a second (3) and a third (4) circumferential cavity are identified, for example with annular morphology. The first circumferential cavity (2) is placed in the upper part, at a distance of 3 ÷ 5 mm from the upper edge of the implant fixture (1).
The second circumferential cavity (3) is placed lower, at a distance of 5 ÷ 7 mm from the upper edge of the implant fixture (1). The third circumferential cavity (4) is placed even lower, at a distance> 5 mm from the lower edge of the implant fixture (1).
According to a preferred embodiment (not shown) the implant fixture (1) is provided with only the first (2) and second (3) circumferential cavities.
According to a further preferred embodiment (not shown)
the implant fixture (1) is provided with only the first circumferential cavity (2).
Said circumferential cavities (2, 3, 4) are connected with a cavity (5) obtained inside the implant fixture (1) through one or more openings (2a, 3a, 4a), for example four for each of the circumferential cavities (2, 3, 4).
According to a preferred embodiment, an implant fixture (10), shown in FIG. 2 (a, b, c), is devoid of circumferential cavities (2, 3, 4), while there is at least one of the openings that connect the internal cavity (5) with the outside. In the illustrated case, the openings (2a) and (4a) are present, corresponding to the circumferential cavities (2) and (4).
Inside said circumferential cavities (2, 3, 4), in the case of the implant fixture (1), and in the openings (2a, 4a), in the case of the implant fixture (10), there is a "carrier" structure composed from polysaccharides of animal origin, for example chitin in solid, semisolid or gel state, the structural formula of which is shown in FIG. 3.
Chitin is a natural polysaccharide formed by N-Acetyl-D- glucosamine residues linked by b1-4 bond. It constitutes the
exoskeleton of crustaceans and insects and the cell wall of fungi and yeasts. It is insoluble in most organic solvents and this characteristic makes its use as it is and its chemical-physical characterization very difficult. It has low toxicity and is inert in the gastrointestinal tract of mammals.
Chitin is only degradable by chitinase, lysozyme and ptyalin. Lysozyme and ptyalin are typically present in fluids that cover anatomical areas (e.g. tears, saliva, crevicular fluid). In the case of the peri-implant sulcus, it has the presence of lysozyme and ptyalin only in the region of the implant neck. The more the collar is exposed as a result of inflammation and loss of bone substance, the greater the area of the implant surface will be exposed to the action of crevicular fluid and therefore of lysozyme.
Inside the cavity (5) there is a coloring agent, for example erythrosine or toluidine blue.
Erythrosine, otherwise called E127 in the European coding of food additives, is an intense red food coloring, which belongs to the chemical class of organoiodides, in particular it is the disodium salt of 2,4,5,7-tetraiodiofluorescein.
Erythrosine E127 is also commonly used as a dental plaque
detecting agent.
Should the collar, due to inflammation and loss of bone substance, be discovered, the crevicular fluid, and therefore the lysozyme, would come into contact with the carrier, attacking it chemically and the coloring agent contained in the reservoir (5) would come out of the openings (2a , 3a, 4a) and would cause staining inside the mouth, such as the tongue or a gum.
The "in situ release" of E127 will create in the patient a "clear, intelligible and unavoidable" perception that something is happening to their oral cavity, creating the urgent conditions for a request for a dental visit.
The simple coloring released by the carrier ring has a diagnostic effect (the release of the dye that "alerts" the patient) and therapeutic (the release of antibiotic and other site-specific therapeutic factors).
In addition to erythrosine, any dye, such as toluidine blue, could be used.
In addition to antibiotics, bacteriostatic, pro-osteogenic growth factors or other bioactive substances can be used.
Claims
1. Implant fixture (1, 10) able to detect autonomously and early the onset of pathological states compatible with peri-implant mucositis, which can evolve in the early stages of peri-implantitis, in order to allow prompt medical intervention on the patient, said implant fixture (1, 10) being inserted into the maxillary and/or mandibular bone, characterized in that it provides an internal cavity (5), put in communication with the outside through at least one opening (2a, 3a, 4a), wherein: - said internal cavity (5) is filled with a coloring fluid;
- said at least one opening (2a, 3a, 4a) is kept inaccessible due to the presence of a chemical compound, namely a carrier, that can be attacked by one or more components present in the crevicular and/or salivary fluid; in such a way that, following a retraction of the gingiva, consequent to an inflammation and loss of peri-implant bone substance, even of a few millimeters, said crevicular and/or salivary fluid comes into contact with the implant fixture (1, 10) in correspondence of said at least one opening (2a, 3a, 4a), due to the loss of bone in which said implant fixture (1, 10) is inserted, said
chemical compound degrading and allowing the coloring fluid to escape which will cause the coloring to inside the mouth in correspondence with the fixture (1, 10), highlighting the presence of said inflammation and loss of peri-implant bone substance.
2. Implant fixture (1, 10) according to claim 1, characterized in that said at least one opening (2a, 3a) are two in number and are respectively placed at a distance of 3 ÷ 5 mm and 5 ÷ 7 mm from the upper edge of the implant fixture (1, 10).
3. Implant fixture (1, 10) according to claims 1 and 2, characterized in that it provides a further opening (4a) located at a distance > 5 mm from the lower edge of the implant fixture (1, 10).
4. Implant fixture (1) according to claims 1 to 3, characterized in that it provides at least one circumferential cavity (2, 3, 4) in correspondence with said at least one opening (2a, 3a, 4a).
5. Implant fixture (1) according to claim 4, characterized in that said chemical compound, i.e. carrier, is present inside said at least one circumferential cavity (2, 3, 4).
6. Implant fixture (1, 10) according to claims 1 to 5, characterized in that said chemical compound, i.e. carrier, is chitin.
7. Implant fixture (1, 10) according to claim 1, characterized in
that said coloring fluid, present in said internal cavity (5), is erythrosine or toluidine blue.
8. Implant fixture (1, 10) according to claim 1, characterized in that said coloring fluid, present in said internal cavity (5), comprises antibiotic and/or bacteriostatic substances and/or pro- osteogenic growth factors.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IT102021000009875A IT202100009875A1 (en) | 2021-04-19 | 2021-04-19 | Implant fixture for the early detection of pathological states of peri-implantitis or peri-implant mucositis |
| IT102021000009875 | 2021-04-19 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2022223134A1 true WO2022223134A1 (en) | 2022-10-27 |
Family
ID=76355458
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/EP2021/064653 WO2022223134A1 (en) | 2021-04-19 | 2021-06-01 | Implant fixture for early detection of pathological states of peri-implantitis or peri-implant mucositis |
Country Status (2)
| Country | Link |
|---|---|
| IT (1) | IT202100009875A1 (en) |
| WO (1) | WO2022223134A1 (en) |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4671768A (en) * | 1982-12-06 | 1987-06-09 | Ton Michael A | Implant as well as a dental prosthesis attached to one or more of such implants |
| US6132214A (en) * | 1995-12-18 | 2000-10-17 | Jouko Suhonen | Medical implant |
-
2021
- 2021-04-19 IT IT102021000009875A patent/IT202100009875A1/en unknown
- 2021-06-01 WO PCT/EP2021/064653 patent/WO2022223134A1/en active Application Filing
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4671768A (en) * | 1982-12-06 | 1987-06-09 | Ton Michael A | Implant as well as a dental prosthesis attached to one or more of such implants |
| US6132214A (en) * | 1995-12-18 | 2000-10-17 | Jouko Suhonen | Medical implant |
Also Published As
| Publication number | Publication date |
|---|---|
| IT202100009875A1 (en) | 2021-07-19 |
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