Side effects of mandibular advancement splints for the treatment of snoring and obstructive sleep apnea: a systematic review

Martins, Olivia de Freitas Mendes; Chaves Junior, Cauby Maia; Rossi, Rowdley Robert Pereira; Cunali, Paulo Afonso; Dal-Fabbro, Cibele; Bittencourt, Lia

doi:10.1590/2177-6709.23.4.045-054.oar

ABSTRACT

Introduction:

Occlusal side effects or development of pain and/or functional impairment of the temporomandibular complex are potential reasons for poor compliance or abandonment of mandibular advancement splints treatment for snoring and obstructive sleep apnea.

Objective:

This study aimed at providing a comprehensive review evaluating the craniofacial side effects of oral appliance therapy for snoring and obstructive sleep apnea.

Methods:

An electronic search was systematically conducted in PubMed and Virtual Health Library from their inception until October 2016. Only Randomized Controlled Trials whose primary aim was to measure objectively identified side effects on craniofacial complex of a custom-made oral appliance for treating primary snoring or obstructive sleep apnea were included. Studied patients should be aged 20 or older. The risk of bias in the trials was assessed in accordance with the recommendations of The Cochrane Risk of Bias criteria.

Results:

A total of 62 full-text articles were assessed for eligibility. After the review process, only 6 met all the inclusion criteria. All studies were rated as having a high risk of bias. The most uniformly reported mandibular advancement splint side effects were predominantly of dental nature and included a decrease in overjet and overbite. The risk of developing pain and function impairment of the temporomandibular complex appeared limited with long-term mandibular advancement splint use.

Conclusion:

The limited available evidence suggests that mandibular advancement splint therapy for snoring and obstructive sleep apnea results in changes in craniofacial morphology that are predominantly dental in nature, specially on a long-term basis. Considering the chronic nature of obstructive sleep apnea and that oral appliance use might be a lifelong treatment, a thorough customized follow-up should therefore be undertaken to detect possible side effects on craniofacial complex. It is also important to provide adequate information to the patients regarding these possible changes, especially to those in whom larger occlusal changes are to be expected or in whom they are unfavorable. Long-term assessments of adverse effects of oral appliance therapy, with larger study samples and recruitment of homogenous patient population are still required.

Keywords:
Obstructive seep apnea; Adverse effects; Mandibular advancement splints; Systematic review

[1] Contact address: Olivia de Freitas Mendes Martins Av. Aviador Irapuã Rocha, 2336, Bairro de Fátima - Teresina/PI, Brasil CEP: 64.048-232 - E-mail: oliviaortodontia@gmail.com.

Author (year)	Method	MAS		Subjects		Control	Follow-up period	MAS Use	Side effects summary
Author (year)	Method	Type	Protrusion	Type	n
Doff et al.¹⁶16 Doff MHJ, Hoekema A, Pruim GJ, Huddleston Slater JJR, Stegenga B. Long-term oral-appliance therapy in obstructive sleep apnea: a cephalometric study of craniofacial changes. J Dent. 2010 Dec;38(12):1010-8. (2010)	Cephalometry	Thornton Adjustable Positioner (TAP®)	79 ± 20% of maximum protrusion	OSA	31	CPAP	2.3 ± 0.2 year	> 6 nights/week	Overbite and overjet decreased; retroclination of the upper incisors and proclination of the lower incisors; lower and total anterior facial height increased significantly; no changes in skeletal variables were found
Doff et al.¹⁰10 Doff MHJ, Veldhuis SK, Hoekema A, Slater JJ, Wijkstra PJ, De Bont LG, et al. Long-term oral appliance therapy in obstructive sleep apnea syndrome: a controlled study on temporomandibular side effects. Clin OralInvestig. 2012 June;16(3):689-97. (2012)	Clinical measurements (RDC/TMD) and questionnaire	Thornton Adjustable Positioner (TAP®)	76 ± 25% of maximum protrusion	OSA	51	CPAP	2 months, 1 year and 2 years	6.7 ± 0.6 nights/week	OA therapy results in more pain-related TMDs in the initial period of use, compared with CPAP therapy
Doff et al.¹⁷17 Doff MHJ, Finnema KJ, Hoekema A, Wijkstra, PJ, Bont LGM, Stegenga M. Long-term oral appliance therapy in obstructive sleep apnea syndrome: a controlled study on dental side effects. Clin Oral Invest. 2013 Mar;17(2):475-82. (2013)	Dental plaster study models	Thornton Adjustable Positioner (TAP®)	79 ± 19% of maximum protrusion	OSA	51	CPAP	2.3 ± 0.2 year	6.9 ± 0.4 nights/week	Decreased overjet/overbite, anteroposterior change in the occlusion, decreased number of occlusal contact points in the posterior region
Ringqvist et al.¹⁴14 Ringqvist M, Walker-Engström ML, Tegelberg A, Ringqvist I. Dental and skeletal changes after 4 years of obstructive sleep apnea treatment with a mandibular advancement device: a prospective, randomized study. Am J Orthod Dentofacial Orthop. 2003 July;124(1):53-60. (2003)	Cephalometry	Non- adjustable	50% of maximum protrusion	OSA	27	Uvulopala-topharyn-goplasty	4.1 year (4.0 - 4.2)	6.1 nights/week	Changes in vertical positions of the maxillary incisors and the mandibular incisors, posterior rotation of the mandible; overjet and overbite did not change significantly
Robertson et al.¹³13 Robertson C, Herbison P, Harkness M. Dental and occlusal changes during mandibular advancement splint therapy in sleep disordered patients. Eur J Orthod. 2003 Aug;25(4):371-6. (2003)	Cephalometry	Non- adjustable	75% of maximum protrusion	OSA/ snoring	100	Pre-MAS therapy	6, 12, 18, 24 and 30 months	> 5-6 hours/nights 7 nights/week	Changes in face height, the position of the mandible, overjet, and overbite occurred as early as 6 months. Over-eruption of the maxillary first premolars and mandibular first molars and proclination of the mandibular incisors were not evident for at least 2 years.
Tegelberg et al.¹⁵15 Tegelberg A, Wilhelmsson B, Walker-Engstrom M, Ringqvist M, Andersson L, Krekmanov L, et al. Effects and adverse events of a dental appliance for treatment of obstructive sleep apnea. Swed Dent J. 1999;23(4):117-26. (1999)	Clinical examination (Helkimo; Eichner index of occlusal support zones)	Non- adjustable	50% of maximum protrusion	OSA	37	Uvulopala-topharyn-goplasty	1 year	6 nights/week	Few adverse events in the stomatognathic system or other complications

Characteristic	Study
Characteristic	Doff et al,¹⁶16 Doff MHJ, Hoekema A, Pruim GJ, Huddleston Slater JJR, Stegenga B. Long-term oral-appliance therapy in obstructive sleep apnea: a cephalometric study of craniofacial changes. J Dent. 2010 Dec;38(12):1010-8. 2010	Doff et al,¹⁰10 Doff MHJ, Veldhuis SK, Hoekema A, Slater JJ, Wijkstra PJ, De Bont LG, et al. Long-term oral appliance therapy in obstructive sleep apnea syndrome: a controlled study on temporomandibular side effects. Clin OralInvestig. 2012 June;16(3):689-97. 2012	Doff et al,¹⁷17 Doff MHJ, Finnema KJ, Hoekema A, Wijkstra, PJ, Bont LGM, Stegenga M. Long-term oral appliance therapy in obstructive sleep apnea syndrome: a controlled study on dental side effects. Clin Oral Invest. 2013 Mar;17(2):475-82. 2013
Sequence generation (selection bias)	Unclear	Unclear	Unclear
Allocation concealment (selection bias)	Unclear	Unclear	Unclear
Blinding of participants and personnel (performance bias)	High: performance bias due to knowledge of the allocated interventions by participants and personnel during the study	High: performance bias due to knowledge of the allocated interventions by participants and personnel during the study	High: performance bias due to knowledge of the allocated interventions by participants and personnel during the study
Blinding of outcome assessment (detection bias)	Low: one blinded observer performed all tracings	Unclear: unclear if outcome assessor was blinded	Low: one blinded observer performed twice all measurements
Incomplete outcome data (attrition bias)	Low: reasons for withdrawals were both reported and balanced across groups	Low: reasons for withdrawals were both reported and balanced across groups	Low: reasons for withdrawals were both reported and balanced across groups
Selective outcome reporting (reporting bias)	Low: pre-specified outcomes were reported	Low: pre-specified outcomes were reported	Low: pre-specified outcomes were reported
Other sources of bias	High: inter- and intraobserver reliability measurements were not carried out	Unclear	Unclear
Overall risk of bias	High	High	High
Characteristic	Study
Characteristic	Ringqvist et al,¹⁴14 Ringqvist M, Walker-Engström ML, Tegelberg A, Ringqvist I. Dental and skeletal changes after 4 years of obstructive sleep apnea treatment with a mandibular advancement device: a prospective, randomized study. Am J Orthod Dentofacial Orthop. 2003 July;124(1):53-60. 2003	Robertson et al,¹³13 Robertson C, Herbison P, Harkness M. Dental and occlusal changes during mandibular advancement splint therapy in sleep disordered patients. Eur J Orthod. 2003 Aug;25(4):371-6. 2003	Tegelberg et al,¹⁵15 Tegelberg A, Wilhelmsson B, Walker-Engstrom M, Ringqvist M, Andersson L, Krekmanov L, et al. Effects and adverse events of a dental appliance for treatment of obstructive sleep apnea. Swed Dent J. 1999;23(4):117-26. 1999
Sequence generation (selection bias)	Unclear	Unclear	Unclear
Allocation concealment (selection bias)	Unclear	Unclear	Unclear
Blinding of participants and personnel (performance bias)	High: performance bias due to knowledge of the allocated interventions by participants and personnel during the study	High: performance bias due to knowledge of the allocated interventions by participants and personnel during the study	High: performance bias due to knowledge of the allocated interventions by participants and personnel during the study
Blinding of outcome assessment (detection bias)	Unclear: unclear if outcome assessor was blinded	Unclear: unclear if outcome assessor was blinded	Unclear: unclear if outcome assessor was blinded
Incomplete outcome data (attrition bias)	High: large number of patients lost to follow up (33% in MAS group)	Low: no missing outcome data	Low: reasons for withdrawals are both reported and balanced across groups
Selective outcome reporting (reporting bias)	Low: pre-specified outcomes were reported	Low: pre-specified outcomes were reported	High
Other sources of bias	High: in the experimental (MAS) and control (UPPP) groups, some patients (10% and 27%) received both treatments	High: no control group	Unclear
Overall risk of bias	High	High	High

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