Rehabilitation strategies in maxillofacial trauma: systematic review and meta-analysis

Oral and Maxillofacial Surgery https://doi.org/10.1007/s10006-019-00808-8 REVIEW ARTICLE Rehabilitation strategies in maxillofacial trauma: systematic review and meta-analysis Karoline Weber dos Santos 1 & Rafaela Soares Rech 1 & Eliana Márcia Da Ros Wendland 2 & Juliana Balbinot Hilgert 1 Received: 14 February 2019 / Accepted: 9 October 2019 # Springer-Verlag GmbH Germany, part of Springer Nature 2019 Abstract Purpose This study aims to investigate rehabilitation strategies to reduce trismus, pain, and edema in patients with maxillofacial trauma. Methods An electronic search in main databases was performed, including studies published until November 2017. Clinical trials aiming to investigate therapeutic techniques to improve mandibular range of motion and to reduce pain and edema compared to other treatments were included. Results Nine studies were included in the review with different therapy modalities: photobiomodulation, kinesiologic tape, hilotherapy, jaw exercises, and TENS. Only five studies had available data to be included in a meta-analysis. There were no differences between any of the proposed strategies and its controls to prevent trismus. Individuals treated with hilotherapy presented less pain compared to controls. Kinesiologic tape or hilotherapy reduced edema when compared to controls daily until postoperative day 3. Conclusions There is diversity among the proposed rehabilitation techniques, and types of fractures and there are few numbers of included participants in each study. The results obtained in this review do not promote evidence to guide the use of non-drug rehabilitation techniques in patients with maxillofacial trauma after surgical intervention. Keywords Edema . Maxillofacial injuries . Oral rehabilitation . Pain . Trismus Introduction Fractures involving bones of the skull and the face, mostly from car accidents and physical aggressions, with a higher Electronic supplementary material The online version of this article (https://doi.org/10.1007/s10006-019-00808-8) contains supplementary material, which is available to authorized users. * Karoline Weber dos Santos karolweber@gmail.com Rafaela Soares Rech rafasoaresrech@hotmail.com Eliana Márcia Da Ros Wendland elianawend@gmail.com Juliana Balbinot Hilgert jhilgert@gmail.com 1 Faculty of Dentistry, Federal University of Rio Grande do Sul (UFRGS), Porto Alegre, RS, Brazil 2 Public Health Department, Federal University of Health Sciences of Porto Alegre (UFCSPA), Porto Alegre, RS, Brazil prevalence in young adult males, are associated with a high cost of hospital admissions [1]. Most individuals have fractures in only one face bone, mainly the mandible. The fracture site has no direct association with the etiology of the trauma and surgical intervention is usually necessary [2, 3]. When the mandible is the affected bone, higher functional limitations are observed, especially when intermaxillary fixation that restricts active mobilization is needed [4, 5]. Trauma may cause temporary or permanent disorders in stomatognathic functions according to its complexity, fracture locations, and proposed interventions [4, 5]. Persistent orofacial pain is the main complaint associated to movement restrictions, bone and tissue asymmetries, and loss of strength of the masticatory muscles [6, 7]. Pain and edema after the trauma and the maxillofacial interventions are also consequences of tissue manipulation [8, 9]. The main dysfunction is the restriction of mandibular range of motion, especially when the mandible is fractured [3–6]. This restriction can be associated with bone misalignments that limit mobility [4, 7]; however, it is usually related to muscular tension caused by a protective containment response also associated with pain and edema [6, 7]. Considering this, therapeutic programs such as Oral Maxillofac Surg photobiomodulation [8], transcutaneous electrical stimulation (TENS), and active jaw mobilization [10] are described in the literature as alternatives to improve mouth functions and reduce discomfort, but the studies were not designed for patients with maxillofacial trauma. Different therapeutic approaches are used to reestablish stomatognathic functions or to reduce discomfort after surgery. Therapeutic programs described in literature vary according to its techniques proposed, being observed a wide range of protocol interventions among the studies, even when the same treatment strategy is used [8]. Particularly in maxillofacial trauma area, few programs were described and there is no uniformity in the techniques characterization. Thus, the identification of the therapeutic efficacy of the techniques to be chosen, that is, its effects on an environment and target audience previously defined as ideal, should be carefully evaluated for proper choice in clinical application [11]. Since there is no consensus among the rehabilitation programs in literature, this study aims to verify the efficacy of different therapeutic techniques compared to each other or to the usual treatments, based on medications, to improve stomatognathic functions in patients affected by maxillofacial trauma through a systematic review of clinical trials. Methods The study protocol was registered in PROSPERO (CRD42017078269) and structured in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The search strategy was defined as: & & & & Participants: individuals with maxillofacial trauma without restricting the location of fracture, with only one or multiple fractures. Data: first author, year of publication, country, mean age and gender in each sample group, maxillofacial fracture diagnosis and maxillofacial surgery performed. Interventions: therapies not based on medications that aim to reduce trismus, pain and edema after trauma or maxillofacial procedures. The treatment protocol and the follow up were registered. Controls: placebos of the main intervention, medications or no treatment. The treatment protocol and the follow up were registered. Outcomes: The main outcome was the mandibular range of motion measured by mouth opening using numerical scales. The secondary outcomes were pain, measured by numerical or visual analog scale, and edema, measured by volumetric assessment or distance between facial points. The search was performed at PubMed/Medline, The Cochrane Central Register of Controlled Trials, EMBASE a nd D e n t i s t r y & O r al S ci en c es S ou r c e ( D O S S) , complemented by manual search at other sources of the health area to reduce selection bias, published until November 2017. There were no restrictions related to language or date of publication. Keywords identified at MeSH and synonyms at Google were used. Interventional prospective studies were included (clinical trials, controlled clinical trials, and randomized clinical trials), since there is few numbers of randomized clinical trials published in literature to be included. The search strategy is presented in Appendix 1. The studies were analyzed initially by title and abstract by two independent authors (KWS and RSR), according to eligibility criteria, identifying them as “included,” “excluded,” or “not clear.” In cases where the inclusion was not clear, a third author resolved discrepancies (JBH). Those included at this stage were read in full for final decision. The selection stages are presented in the flow diagram in Fig. 1. The characteristics of the studies and the outcomes were extracted to a specific form designed for this study. The data were extracted was also performed by two independent authors (KWS and RSR) and with further discussion by all authors. In cases of missing data, the authors were contacted for clarification and if lack of answers, classified as incomplete in quality analysis. The risk of bias was classified using the Cochrane Collaboration’s tool [12] for assessment by two independent evaluators (KWS and RSR): “Low risk,” in green; “High risk,” in red; and “Unclear risk,” in yellow (Fig. 2). Disagreements were discussed until consensus with other authors. Studies that presented quantitative data were included in the meta-analysis. The estimated effect of a treatment between groups was expressed as mean difference, when the use of the same measurement scale was used between studies, or standardized mean difference, when the studies measured the same outcome but with different methods, with a 95% confidence interval. Heterogeneity was calculated using the chi-squared test (χ2), considered significant at p < 0.10. The quantifying inconsistency was expressed by I2, considering values greater than 50% as substantial heterogeneity. A fixed-effects model was used for calculation of summary estimates and their 95% confidence interval, unless there was significant heterogeneity, which was analyzed by a random-effects statistical model. Sensitivity analysis was performed on the results with high heterogeneity to assess the robustness of the data, excluding studies with high risk of bias and analyzing the effect on the overall estimates. Subgroup analysis was performed to compare different types of interventions keeping the same heterogeneity analysis previously described. Oral Maxillofac Surg Fig. 1 Flow diagram Meta-analysis was performed on software RevMan v5.3 and agreement between evaluators on Spss v.22. Results After removing duplicates, 5949 studies were screened. Of these, 33 articles were assessed for eligibility. After screening the full text, seven studies were included in qualitative synthesis [13–19] and five at quantitative analysis [14–17, 19] (Fig. 1). Inter-rater agreement of the search strategies, article inclusion, and data extraction were assessed using the kappa coefficient, with the following results, respectively: 0.95, 1, and 0.98, demonstrating a great agreement between the authors. The characteristics of included studies are presented in Table 1. Six studies were performed with two [13–17, 19] groups without crossover treatment and only one with one group [18]. The patients had fractures in the middle [14, 15] or lower third of the face [13, 16, 17, 19] or multiple maxillofacial fractures [18]. Men were the most affected in all studies with age around 40 years old. Regarding maxillofacial intervention, open reduction and internal fixation were performed in six studies [13–18], being in one of them associated with intermaxillary fixation for 1 week after surgery, without mentioning if rigid or elastic [18], and one study performed only intermaxillary fixation with elastics for 6 weeks [19]. Both studies that used intermaxillary fixation did not differentiate the procedure as intraoperative or postoperative. All included studied began the rehabilitation program immediately after surgery. The studies had different amounts of therapeutic sessions ranging from only one to weekly until 12 weeks after surgical procedure. Five studies used the same medicine therapy for both studied groups [13–17]. Concerning the rehabilitation techniques, one study described a photobiomodulation therapy using laser compared to a placebo treatment [13]. Two studies used kinesiologic tape associated with regular medicine treatment and ice packing compared to individuals without tape [14, 16]. Two studies compared different methods of cooling (hilotherapy X ice packing) [15, 17]. One study investigated oral exercises as the main intervention without a control group [18] and one study investigated TENS compared to treatment with medicines [19]. Oral Maxillofac Surg measures that do not depend on the individual’s response that could generate bias, on the contrary if the examiner’s blinding was not performed. In this case, only one study was considered low risk. Those that received a high or unclear risk did not blind the participants and not assure a blinded evaluation [14, 16, 18] or did not clearly specify blinding [13, 15, 19]. Incomplete outcome data Most of the studies had a low-risk classification due to the well-presented data about recruitment and follow-up [13, 15–17, 19]. One study had poor methodological description without enough information to be classified as low risk [18], and one did not specify loss of follow-up, with insufficient information concerning the sample size in results to evaluate missing data [14]. Selective reporting Most studies presented enough information and outcome descriptions [13–17] that allow reproducibility. Two studies were classified as high risk [18, 19] due to low quality of description in the methodology and the results session. The procedures were poorly described, not being possible to reproduce the study or the results were biased. Other potential sources of bias We consider that the main aspects about bias were adequately evaluated in the other sessions, and no other aspects that could generate bias were identified. Effects of interventions Fig. 2 Risk of bias in included studies Risk of bias in included studies Allocation Most of the studies presented a high or unclear risk [15, 17–19]. The authors did not perform randomization [18] or described subjects as randomly assigned but with insufficient information to determine allocation concealment [15, 17, 19]. Blinding Four studies presented a low risk of blinding of participants and personnel [13–15, 17]. Some proposed interventions did not allow blinding of the participants due to the nature of the treatment, but it is still not a justifiable aspect to consider a low bias, most of the studies were thus classified because it is understood that the investigated outcomes are objective Although the location of the fracture is a factor that influences the analyzed outcomes and was considered an important variable for data stratification in the protocol of this systematic review, it was not possible to be performed due to the few number of articles in the literature. Nevertheless, a sensitivity analysis was performed removing studies with different types of fracture and no difference was observed in results of the meta-analysis. Considering that we included studies with different types of fractures and few number of included studies, we decided not to perform an indirect meta-analysis between different rehabilitation strategies because those results could be biased and not bring adequate information. Nevertheless, it was decided to compare the use of different techniques versus the use of conventional practice in order to verify the effect of using any additional technique to clinical practice, regardless of the treatment method chosen. Thus, the studies were grouped according to days after intervention in each outcome in order to investigate the effects in an overall way for patients with Characteristics of included studies First author Year Country Study design Population N (mean age (years)) Gender (F/M) Diagnosis Maxilofacial surgery Intervention group Lauriti 2017 Brazil Randomized control trial I: 6 C: 6 (34.5 ± 7) 12 (M) Mandibular fractures Open reduction and internal fixation Ristow 2014 Germany Randomized 30 (41.4 ± 18.5) clinical trial 14/16 Zygomatic-orbital Open reduction and internal fixation fracture and zygomatic maxillary fracture involving orbital floor Modabber Randomized control trial 2013 Germany I: 21 (36.5 ± 16.1) I: 4/17 C: 21 (35.6 ± 21.9) C:3/18 Unilateral zygomatic bone fractures Open reduction and internal fixation Ristow 2013 Germany Randomized control trial I: 13 (43.8 ± 20.7) I: 7/6 C: 13 (42.5 ± 16.7) C: 4/9 Mandibular fractures Open reduction and internal fixation Rana 2013 Germany Randomized control trial I: 16 (27.1 ± 11.9) I: 3/13 C: 16 (33.4 ± 13.3) C: 2/14 Bilateral mandibular fractures Open reduction and internal fixation Control group Treatment protocol Laser therapy + Laser sham + - 3 sections per week antibiotics and antibiotics and beginning anti-inflammatory anti-inflammatory immediately after steroids steroids surgery. 15 sections: 0, 7, 14, 30 and 60 days after surgery. - Drug therapy not described Kinesiologic tape + Analgesic drug - Kinesiologic tape left analgesic drug therapy + ice pack at least 5 days therapy + ice pack application 6 h (edges were application 6 h after surgery trimmed if tape after surgery (alternating each lifted before (alternating each 30 min) removal.) 30 min) - Drug therapy for 3 days in both groups - Both cooling Conventional Hilotherapy + methods were cooling + analgesic drug initiated after analgesic drug therapy surgery until therapy postoperative day 3 continuously for 12 h daily. - Drug therapy for 3 days in both groups Kinesiologic tape + Analgesic drug - Kinesiologic tape left analgesic drug therapy + ice pack at least 5 days therapy + ice pack application 6 h (edges were application 6 after surgery trimmed if tape hours after surgery (alternating each lifted before (alternating each 30 min) removal.) 30min) - Drug therapy for 3 days in both groups Conventional Hilotherapy + - Both cooling cooling + analgesic drug methods were analgesic drug therapy initiated after therapy surgery until postoperative day 3 continuously for 12 h daily. - Drug therapy for 3 days in both groups Evaluation follow-up - Mouth opening, pain and edema: 7, 14, 21, 30, and 60 days after surgery - Any loss of follow-up - Mouth opening, pain and edema: preoperative, after operation, 1, 2, 3, and 7 postoperative days - Loss of follow-up: not mentioned - Edema: 1, 2, 3, 7, and 28 postoperative days. The 90 postoperative day ware considered the reference of patient. - Pain: preoperative, 1, 2, and 7 postoperative days - Any loss of follow-up - Mouth opening, pain and edema: preoperative, after operation, 1, 2, 3, and 7 postoperative days - Any loss of follow-up - Mouth opening: before and directly after surgery, 2, 10, 28, and 90 days after surgery - Pain: preoperative, 1, 2, and 10 postoperative days - Edema: 1, 2, 3, 10, and 28 postoperative days. The Oral Maxillofac Surg Table 1 Table 1 (continued) First author Year Country Study design Population N (mean age (years)) Gender (F/M) Feng 2009 China Clinical trial 117 (range 31/86 between 19 and 62) Fagade 2005 Nigeria Randomized control trial I: 10 (34,5) C: 10 (36,2) I: 4/6 C: 6/4 Diagnosis Maxilofacial surgery Intervention group Single or multiple Open reduction and Jaw exercises jaw fractures, internal fixation + with or without Intermaxillary fracture of the fixation with zygoma and elastics for 1 week zygomatic arch but no deossification Simple and Intermaxillary Jaw exercises with unilateral fixation for 6 wooden spatula + mandibular weeks TENS + jaw fracture exercises again Control group No controls Jaw exercises with wooden spatula + analgesic treatment (1000 mg paracetamol) + jaw exercises again Treatment protocol Evaluation follow-up 90 postoperative day ware considered the reference of patient - Any loss of follow-up Weekly, until 12 - Mouth opening: 1, 4, 8, weeks after surgery and 12 postoperative weeks - Any loss of follow-up One session after - Mouth opening: the removal of the maximum number of Intermaxillary wooden spatula that the fixation patient could tolerate - Did the exercise, and the inter-incisal disapplied TENS for tance were measured 30 minutes and then before and after each repeat the exercises treatment - Did the exercise, took medication and wait 30 min to repeat the exercises F female, M male, I intervention group, C control group, TENS transcutaneous electrical nerve stimulation Oral Maxillofac Surg Oral Maxillofac Surg maxillofacial fractures. The effects of intervention presented different results according to the outcome evaluated. Trismus Four studies compared the mandibular range of motion by mouth opening with five different modalities of treatment: laser therapy [13], kinesiologic tape [14, 16], hilotherapy [17], oral exercises [18], and TENS [19]. All studies presented results with improvement in mandibular range of motion after interventions, but with no difference between the study groups in all proposed treatments at any time. Pain Three modalities of treatment were proposed to reduce pain: laser therapy [13], kinesiologic tape [14, 16] and hilotherapy [15, 17]. No difference between the investigated groups was found using laser therapy. The patients who received hilotherapy presented better results compared to the usual treatment in 1 and 2 days of intervention when the mandible [17] or the zygomatic bone [15] was affected, without difference between study groups using kinesiologic tape (Fig. 3). Edema Five articles measured edema in different times of investigation using laser therapy [13], hilotherapy [15, 17], and kinesiologic tape [14, 16] as experimental group. Using laser therapy [13], no difference was found between the study groups. After 1 day of intervention [14–17], individuals treated as the experimental group presented statistical reduced edema, compared to controls, using hilotherapy [15, 17] and kinesiologic tape [14]. Considering the measures 2 and 3 days after intervention, there was a statistical difference between experimental and control groups, but with high heterogeneity Fig. 3 Meta-analysis of outcome pain among studies (I2 > 50%), even when a random effect model was applied. Performing a sensitivity analysis, considering only studies with low risk of bias in blinding [15–17], individuals treated as experimental group also presented statistical reduced edema compared to controls and low heterogeneity between studies after 2 days after intervention. The final sensitivity analysis is presented in Fig. 4. Discussion The results of this systematic review present different strategies of rehabilitation after surgical procedures in patients with maxillofacial trauma without guidance regarding the best treatment option. The orientation of orofacial rehabilitation after trauma, especially with mandibular involvement, recommends the use of exercises after surgical interventions to restore mouth opening and mandibular functionalities [4–6], which was observed to be little used, being identified only in two included studies [18, 19]. The association of complementary therapeutic methods with interventions conventionally used, fundamentally based on medicines, may favor recovery of pain and edema and provide comfort to the patient at the postoperative moment, as observed in the experimental group of the presented studies in different types of bones fractures. The presence of mandibular trismus is one of the main disturbances observed in patients with facial trauma [6, 7]. Rehabilitation techniques should be performed to minimize the range of motion deficit after maxillofacial intervention and to restore normal amplitude in order to improve stomatognathic functions [4, 5]. We identified studies that used laser therapy [13], kinesiologic tape [14, 16], hilotherapy [17] and TENS [19], but those interventions did not present better results compared to controls. The use of laser therapy has been widely studied in the maxillofacial area, with favorable results for the management of trismus, since it increases the ATP synthesis and, consequently, the muscle activity Oral Maxillofac Surg Fig. 4 Meta-analysis of outcome edema. Legend: Risdow 2013 was removed from the final model after sensitivity analysis Legend: Risdow 2013 was removed from the final model after sensitivity analysis. [20–22]. The authors of the included study identified improvement of mouth opening earlier in the treated group [13]; however, due to the small number of participants included, this difference did not appear to be significant. The strategies based on kinesiologic tape and hilotherapy act on the reduction of local inflammatory response [14, 16, 17], but do not act directly on the muscular performance in order to promote mobility improvement. The only study that used oral exercises in both groups, as recommended by the literature, presented good improvement for the entire sample independently of the main strategy to reduce pain. As mentioned before, the use of oral exercises promotes the mobilization of the masticatory muscles, reducing the presence of trismus [7]. This technique has a high level of evidence that supports its use for the management of trismus and painful response especially in patients with chronic orofacial pain [22, 23], but few studies have evaluated its applicability in the treatment of maxillofacial trauma. Its indication is found in many maxillofacial surgery guidelines [4–6], but there is a lack of protocols in literature to guide practice, and the results in this review are insufficient to provide new orientation about that. Postoperative pain is also a factor that may limit mouth opening, leading to increased use of medications for symptomatic relief, and may become persistent if untreated [21,23]. Two rehabilitation techniques were identified, kinesiologic tape and hilotherapy, but only the latter favored symptomatic relief when compared to controls [15–17]. The benefits of stimulating local circulation through constant cooling favors pain relief and can contribute to reduce medicine intake in different types of fractures, promoting patient comfort even though it does not favor the reestablishment of mouth opening [15, 17]. The presence of postoperative edema results from the surgical manipulation of bone fragments and tissues and also the surgical incision required for the procedure [21]. Its treatment is usually performed with medicines [21, 23], as presented in all studies included in this review. Despite this, the use of antiedematous drugs is restricted for some patients, who may benefit from complementary techniques if effective. The use of photobiomodulation has been pointed out as a good tool to control postoperative edema in the maxillofacial area [21, 24], but the only study that used it in trauma did not find differences between its groups. The use of hilotherapy and kinesiologic tape led to less postoperative edema in individuals in the experimental groups, with no difference between therapeutic techniques. After a sensitivity analysis, individuals exposed to the complementary rehabilitation strategies presented less edema compared to individuals treated only with medicines until three postoperative days. Despite the differences in the complication rate of the different treatment modalities that influence the results of the present systematic review, these findings could help to guide the use of non-drug therapies after surgery in order to control edema. We found few non-surgical rehabilitation studies for inclusion in this review, meaning that the evidence in this area is still limited. There is diversity among the proposed rehabilitation techniques and types of fractures, and there are few included participants in each study, which may compromise the clinical significance of the results, making it not possible to homogenize the indications and contraindications of those strategies. Besides, it is necessary that further researches using oral exercises be performed in order to clarify its role since it is usually indicated after maxillofacial interventions. The methodological quality of the studies also limits its reproducibility, Oral Maxillofac Surg making evidence of rehabilitation strategies still insufficient to guide protocols. It is important to emphasize the diversity of population included in this review. Different types of trauma can affect the assessed outcomes in different ways and should be analyzed separately, but there are few studies to allow this evaluation. Despite this, this review is relevant to present interventions not based on medicines that may contribute in the maxillofacial rehabilitation process and the importance of future researches in the area. For future studies, it is important that further efficacy studies be conducted to identify the effects of the techniques used, as there is a scarcity of evidence to guide clinical practice. Besides that, the bias should be adequately controlled based on the thorough elaboration of clinical trial protocols based on CONSORT. Other outcomes, as bite force and improvement in food texture, should be analyzed in follow-up in order to provide better data regarding long-term stomatognathic functionality. 3. 4. 5. 6. 7. 8. 9. Conclusion 10. The results obtained in this review are still insufficient to promote evidence that allow a clear definition of how to use non-drug rehabilitation techniques in patients with maxillofacial trauma since there are few studies with reasonable methodological quality, with a low quality of evidence according to GRADE assessment. It is important that future randomized clinical trials with appropriate methodological propositions be performed in order to provide evidence in the area before definitive conclusions can be provided. 11. 12. 13. Acknowledgments Juliana Balbinot Hilgert thanks CNPq (Brazilian National Research Council) for her productivity grant. Compliance with ethical standards Conflict of interest The authors declare that they have no conflict of interest. 14. Ethical approval This article does not contain any studies with human participants or animals performed by any of the authors. 15. References 1. 2. 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