A Systematic Review of Oral Modifications Caused by the Prolonged Application of Continuous Positive Airway Pressure (CPAP) and Intraoral Appliances in Patients with Obstructive Sleep Apnea (OSA)
Study design: retrospective study Trial location: Japan
Participants
Number of participants: 64 patients Eligibility criteria: average age at start of treatment: years. The average duration of treatment was years
Intervention
Intervention: participants with OSA who received long-term oral treatment
Outcome
Primary outcome: As a result of the complete treatment, there was a significant reduction in overjet ( mm) and overbite ( mm), and an increase in the lower incisor line to the mandibular plane (3.1 5.4°). Treatment duration, use frequency, and mandibular advancement of the OAs were associated with greater reductions in OJ by 1 mm Secondary outcome: no significant skeletal changes were found after long-term treatment
Notes
Ethics approval: Osaka University Dental Hospital, No. H28-E20
Risk of bias
Bias
Authors’ judgment
Support for judgment
Random sequence generation (selection bias)
High risk
Allocation was not random
Allocation concealment (selection bias)
High risk
Subjects were paired according to age, type of surgery, educational attainment, and operative experience
Blinding of participants and personnel (performance bias)
High risk
There was no possibility of blinding
Blinding of outcome assessor (detection bias)
Low risk
Blinding is done
Incomplete outcome data (attrition bias)
Low risk
Due to the retrospective nature of the study, it was not possible to exclude participants from the study.
Selective reporting (reporting bias)
Low risk
All the prespecified outcomes in the method section were addressed adequately
Other biases
Work for this study was performed at the Osaka University Graduate School of Dentistry. The authors report no conflicts of interest.
Study design: randomized controlled study Trial location: Netherlands
Participants
Number of participants: 103 participants, age: years Eligibility criteria: Participants were individuals with obstructive sleep apnea syndrome who had received oral therapy or positive airway pressure therapy (CPAP).
Intervention
Intervention: Fifty-one participants were randomized to oral appliance therapy Control: 52 participants to CPAP therapy Treatment was at least 2 years
Outcome
Primary outcome: An oral appliance, in comparison with CPAP, resulted in small but significant (dental) changes. The lower and total anterior facial height increased significantly, by 0.8 (±1.5) mm and 0.9 (±1.4) mm, respectively The secondary outcome was the absence of any changes in skeletal variables.
Notes
Ethics approval: the Groningen University Medical Center’s Ethics Committee
Risk of bias
Bias
Authors’ judgment
Support for judgment
Random sequence generation (selection bias)
Low risk
Allocation was random
Allocation concealment (selection bias)
High risk
Participants were divided into two groups: oral appliance therapy and CPAP therapy.
Blinding of participants and personnel (performance bias)
High risk
Due to the nature of the study, it was not possible to blind
Blinding of outcome assessor (detection bias)
Unclear
Blinding is not explained.
Incomplete outcome data (attrition bias)
High risk
31 and 37 patients were divided into oral group and CPAP group, respectively. Other subjects were excluded from the study
Selective reporting (reporting bias)
Low risk
In the method section, all of the prespecified outcomes were adequately addressed
Other biases
Ethics approval for the present study was obtained from the Ethics Committee of Groningen University Medical Center. Each patient provided written informed consent prior to enrolment No information has been provided regarding the funding organization
Study design: retrospectively study Trial location: Columbia
Participants
Number of participants: 62 participants, average age at start of treatment: years Eligibility criteria: adults with mild to severe wheezing or OSA. At least 8 years have passed since treatment
Intervention
Subjects had been receiving OAM therapy for at least 8 years
Outcome
Primary outcome: that there are significant and progressive dental changes with prolonged OAM use. Over the same time period, skeletal or postural changes were negligible. Secondary outcome: treatment duration was the predictor consistently associated with the magnitude of the observed side effects
Notes
Ethics approval
Risk of bias
Bias
Authors’ judgment
Support for judgment
Random sequence generation (selection bias)
High risk
Allocation was not random
Allocation concealment (selection bias)
High risk
Due to the nature of the study, it was not possible to conceal the allocation
Blinding of participants and personnel (performance bias)
High risk
There was no possibility of blinding
Blinding of outcome assessor (detection bias)
Unclear
Blinding is not explained.
Incomplete outcome data (attrition bias)
Low risk
All the prespecified outcomes in the method section were addressed adequately
Selective reporting (reporting bias)
All the prespecified outcomes in the method section were addressed adequately
Other biases
No funding was provided for this study Ethics approval has been obtained. There was no conflict of interest.
Study design: retrospective study Trial location: China
Participants
Number of participants: 412 participants. Eligibility criteria: participants with OSAHS receiving OA treatment
Intervention
412 participants with OSAHS receiving OA treatment
Outcome
Primary outcome: Following the OA, the apnea-hypopnea index values were reduced from a median of 24.50 (quartiles, 14.65, 54.05) to 7.40 (2.12, 10.00) at baseline and to 4.25 at follow-up, respectively. Secondary outcome: Cephalometric analysis indicated mild and slow changes in the skeleton and occlusion after 5 years.
Notes
Ethics approval: UBC Clinical Research Ethics Board H11-01661.
Risk of bias
Bias
Authors’ judgment
Support for judgment
Random sequence generation (selection bias)
High risk
Allocation was not random
Allocation concealment (selection bias)
High risk
Subjects were paired according to age, type of surgery, educational attainment, and operative experience
Blinding of participants and personnel (performance bias)
High risk
There was no possibility of blinding
Blinding of outcome assessor (detection bias)
Unclear
Blinding is not explained.
Incomplete outcome data (attrition bias)
Low risk
All the prespecified outcomes in the method section were addressed adequately
Selective reporting (reporting bias)
Low risk
All the prespecified outcomes in the method section were addressed adequately
Other biases
The research was partly supported by the Capital Characteristics of Clinical Application Fund (D101100050010019). Ethics approval has been obtained.
Study design: retrospectively study Trial location: Italy
Participants
Number of participants: 20 participants Eligibility criteria: MAD therapy for more than 2 years without treatment discontinuation during the whole study period, MAD use for a minimum of 5 nights per week and usually for the entire night (assessed through a questionnaire administered at the long-term follow-up day), and availability of good quality study models and lateral cephalograms at the baseline and follow-up visits
Intervention
Participants had mild, moderate, and severe snoring that lasted an average of years.
Outcome
Primary outcome: the maxilla revealed a significant decrease in horizontal position and a significant retroclination of the upper incisor, while the mandible displayed a significant downward rotation and a proclination of the lower incisor Secondary outcome: decrease in upper total space discrepancy, overjet, and overbite. In the regression analysis, treatment time influenced the lower incisor inclination and OJ; participants’ initial characteristics had an effect on OJ.
Notes
Ethics approval: This study was approved by the Institutional Review Board (N. 268/15)
Risk of bias
Bias
Authors’ judgment
Support for judgment
Random sequence generation (selection bias)
High risk
Allocation was not random
Allocation concealment (selection bias)
High risk
Due to the nature of the study, it was not possible to conceal the allocation
Blinding of participants and personnel (performance bias)
High risk
There was no possibility of blinding
Blinding of outcome assessor (detection bias)
Unclear
Blinding is not explained.
Incomplete outcome data (attrition bias)
Low risk
All the prespecified outcomes in the method section were addressed adequately
Selective reporting (reporting bias)
High risk
Supplementary material is available at the European Journal of Orthodontics online.
Other biases
No funding was provided for this study. There was no conflict of interest
Study design: prospective study Trial location: Japan
Participants
Number of participants: 46 participants Eligibility criteria: (1) stop using nCPAP, (2) poor compliance (4 h/d or, 5 d/wk), (3) use of a nasal pillow or fullface type mask, (4) poor quality baseline radiograph for evaluation.
Intervention
Both baseline and follow-up cephalometry radiographs were obtained from 46 Japanese subjects who used nCPAP for at least two years. These two radiographs were analyzed, and changes in the craniofacial structures were assessed.
Outcome
Primary result: Cephalometric variables after nCPAP use showed significant anterior maxilla retrusion, decreased maxillary to mandibular discrepancy, supramental and chin position setback, maxillary incisor retroclination, and decreased facial convexity. Secondary result: No significant correlations were observed between craniofacial alterations, demographic characteristics, or nCPAP duration and no self-reported permanent changes in occlusion and facial profile
Notes
Ethics approval: The study protocol was approved by the local Kirigaoka Tsuda Hospital review board
Risk of bias
Bias
Authors’ judgment
Support for judgment
Random sequence generation (selection bias)
Unclear
How to randomize participants is not mentioned.
Allocation concealment (selection bias)
High risk
Due to the nature of the study, it was not possible to conceal the allocation
Blinding of participants and personnel (performance bias)
High risk
There was no possibility of blinding
Blinding of outcome assessor (detection bias)
Unclear
Blinding is not explained.
Incomplete outcome data (attrition bias)
Low risk
All prespecified results under the method section were satisfactorily addressed
Selective reporting (reporting bias)
Unclear
All prespecified results in the method section were satisfactorily addressed.
Other biases
Funding/support: Financial support for this study was received from the MITACS Graduate Research Internship Program. A MITACS Accelerate Internship Grant supported in part the postdoctoral fellow salary of H. Tsuda. No funding was provided for this study.
Study design: prospective study Trial location: Sweden
Participants
Number of participants: 77 people were included in the study Eligibility criteria: sufficient number of teeth to retain an MPD, good dental health, and a maximum protrusion range of $6 mm as measured with the George Gauge instrument (Boos Dental Laboratories, MN).
Intervention
Use of the mandibular protrusion device (MPD) in people with obstructive sleep apnea
Outcome
Primary outcome: The degree of deviation of the maxillary incisors decreased Secondary outcome: Significant changes in overjet and overbite reduction were observed in the MPD group
Notes
Ethics approval: The study is endorsed by the Orebro University Ethics Committee
Risk of bias
Bias
Authors’ judgment
Support for judgment
Random sequence generation (selection bias)
High risk
The distribution was not randomly chosen.
Allocation concealment (selection bias)
High risk
Experiments were matched based on MPD usage and discontinuation of MPD usage
Blinding of participants and personnel (performance bias)
High risk
After ten years, 12 participants went blind
Blinding of outcome assessor (detection bias)
Unclear
Blinding is not explained
Incomplete outcome data (attrition bias)
Low risk
The method section addressed all the prespecified outcomes.
Selective reporting (reporting bias)
Low risk
The method section addressed all the prespecified outcomes.
Other biases
All subjects provided informed consent after practicing about the study’s purpose. The study has indeed been authorised by the Orebro University Ethics Committee. The funding organization has not been disclosed.
Study design: randomized controlled trial Trial location: Netherlands
Participants
Number of participants: 94 people Eligibility criteria: Participants were individuals with obstructive sleep apnea syndrome who had received oral TAP or SomnoDent or positive airway pressure (CPAP) therapy
Intervention
Intervention group: 29 people in TAP group, 31 people in SomnoDent and control group, and 34 people in the CPAP group
Outcome
Primary outcome: The number of occlusal contact points in the premolar region decreased in all three groups Secondary outcome: Overbite changed in all three groups
Notes
Ethics approval
Risk of bias
Bias
Authors’ judgment
Support for judgment
Random sequence generation (selection bias)
Low risk
Allocation was random
Allocation concealment (selection bias)
High risk
Due to the nature of the study, it was not possible to conceal the allocation
Blinding of participants and personnel (performance bias)
High risk
Due to the nature of the study, it was not possible to blind
Blinding of outcome assessor (detection bias)
Unclear
Blinding is not explained.
Incomplete outcome data (attrition bias)
High risk
29 participants in TAP group, 31 participants in SomnoDent, and 34 participants in CPAP group were excluded from the study
Selective reporting (reporting bias)
Low risk
All outcomes clarified in the method section were fully explained.
Other biases
The funding organization has not been reported The authors report no conflicts of interest
Study design: retrospective study Trial location: Canada
Participants
Number of participants: 77 people with a mean age Eligibility criteria: has been treated with OSA for at least 8 years using MAS, continuous use of the device at night
Intervention
Treatment of obstructive sleep apnea (OSA) using long-term treatment of mandibular progressive splint (MAS)
Outcome
Primary outcome: Over time, a significant decrease was observed in overbite and overjet Secondary outcome: The overjet decreased continuously with a constant trend over time
Notes
Ethics approval: The Clinical Research Ethics Board of the University of British Columbia approved this study.
Risk of bias
Bias
Authors’ judgment
Support for judgment
Random sequence generation (selection bias)
High risk
Allocation was not random
Allocation concealment (selection bias)
High risk
Subjects were paired based on the history of MAS use and the presence of dental plaster
Blinding of participants and personnel (performance bias)
High risk
There was no possibility of blinding
Blinding of outcome assessor (detection bias)
Unclear
Blinding is not explained
Incomplete outcome data (attrition bias)
Low risk
Due to the retrospective nature of the study, it was not possible to exclude participants from the study
Selective reporting (reporting bias)
Low risk
All reports are given in the measurement method section
Other biases
It was not an industry-supported study. The University of British Columbia garnered assistance in the form of oral appliance royalties and a UBC Undergraduate Student Summer Internship Award. The authors have reported no financial conflicts of interest. The research was performed out at the Department of Oral Health Sciences, Faculty of Dentistry, University of British Columbia, Vancouver, BC, Canada.
Study design: a randomized trial study Trial location: Egypt
Participants
Participants: 31 people over 20 years old Eligibility criteria: having OSA, use alternative therapy at any time during follow-up, using oral devices for more than 5 nights a week and more than 6 hours a night
Intervention
10 participants in the maxillary splint (MAS) group, 10 participants in the tongue stabilization device (TSD), and 11 participants in the control group for continuous positive airway pressure therapy (CPAP)
Outcome
Primary outcome: MAS and TSD treatment showed small but significant dental changes compared to CPAP. Secondary outcome: In the MAS group, overbite and overjet were significantly reduced
Notes
Ethics approval: not reported
Risk of bias
Bias
Authors’ judgment
Support for judgment
Random sequence generation (selection bias)
Low risk
The distribution was random.
Allocation concealment (selection bias)
High risk
Due to the nature of the study, it was not possible to conceal the allocation
Blinding of participants and personnel (performance bias)
High risk
Due to the nature of the study, it was not possible to blind
Blinding of outcome assessor (detection bias)
Unclear
Blinding is not explained
Incomplete outcome data (attrition bias)
High risk
10 participants in the mandibular progression splint group (MAS), 10 participants in the tongue stabilization device (TSD), and 11 participants in the control group under continuous positive airway pressure (CPAP) were excluded from the study
Selective reporting (reporting bias)
Low risk
All the prespecified outcomes in the method section were addressed adequately
Other biases
Written informed consent was obtained from each patient before enrolment The funding organization has not been reported
Study design: prospective study Trial location: Australia
Participants
Number of participants: 52 Eligibility criteria: subjects with maxillary and mandibular first permanent molars and canines. Subjects who had worn a MAS continuously (minimum of five to six hours per night) for at least 6 months
Intervention
17 subjects wore soft elastomeric monoblock appliances, and 29 subjects wore hard acrylic
Outcome
Primary outcome: measurement of dental and arch changes on study models using standard biting radiographs Secondary outcome: BD users decreased in the distance between maxillary canines and increased in the distance between mandibular molars
Notes
Ethics approval: not reported
Risk of bias
Bias
Authors’ judgment
Support for judgment
Random sequence generation (selection bias)
High risk
Allocation was not random
Allocation concealment (selection bias)
High risk
Subjects were paired based on the use of monoblock and double-block devices
Blinding of participants and personnel (performance bias)
High risk
There was no possibility of blinding
Blinding of outcome assessor (detection bias)
Unclear
Blinding is not explained
Incomplete outcome data (attrition bias)
Low risk
All the prespecified outcomes in the method section were addressed adequately
Selective reporting (reporting bias)
Low risk
All the prespecified outcomes in the method section were addressed adequately
Other biases
No funding was provided for this study There was no conflict of interest
Study design: retrospective study Trial location: Canada
Participants
Number of participants: 21 participants (15 males, mean age y.o), with a mean treatment length of years ( to 14.3 years) Eligibility criteria: participants who wish to participate and have completed their informed consent. Participants who use OAM regularly and for at least 4.5 years. Use OAM for at least 5 nights a week and at least 4 hours a night. Availability of good quality pretreatment records for existing participants. The patient is at least 19 years old or older. The patient is able to understand and communicate in English
Intervention
Clinical follow-up of teeth through cephalograms and dental molds
Outcome
Primary outcome: PSR Absence of active periodontal disease using data Secondary outcome: with continuous use of OAM at different evaluation time periods, clinical crown height did not change
Notes
Ethics approval: University of British Columbia, Vancouver, No. H14-00743
Risk of bias
Bias
Authors’ judgment
Support for judgment
Random sequence generation (selection bias)
High risk
Allocation was not random
Allocation concealment (selection bias)
High risk
The subjects were paired based on cephalometric information
Blinding of participants and personnel (performance bias)
High risk
There was no possibility of blinding
Blinding of outcome assessor (detection bias)
Unclear
Blinding is not explained
Incomplete outcome data (attrition bias)
Low risk
Due to the retrospective nature of the study, it was not possible to exclude participants from the study
Selective reporting (reporting bias)
Low risk
All reports are given in the measurement method section
Other biases
The study was conducted at UBC Sleep Clinic and a clinic-affiliated private practice The study has a code of ethics
Study design: retrospective study Trial location: Spain
Participants
Number of participants: 18 people in the age range of 29 to 63 years, including a woman and 17 men Eligibility criteria: use of MAD as a treatment for OSA and availability of images required for this study
Intervention
CBCT scans of 0.3 mm voxel size were taken with the Carestream CS 9300 Select (Rochester, New York, USA), exposition 80 Kv 4 mA 8.01 s, dose 448 mGy cm2, size , and image according to manufacturer’s settings.
Outcome
Primary outcome: Symptoms can be seen using CBCT images Secondary outcome: MAD causes skeletal changes
Notes
Ethics approval: not reported
Risk of bias
Bias
Authors’ judgment
Support for judgment
Random sequence generation (selection bias)
High risk
Allocation was not random
Allocation concealment (selection bias)
High risk
Subjects were paired based on cone-beam computed tomography (CBCT) images in MAD consumers
Blinding of participants and personnel (performance bias)
High risk
There was no possibility of blinding
Blinding of outcome assessor (detection bias)
Unclear
Blinding is not explained
Incomplete outcome data (attrition bias)
Low risk
Due to the retrospective nature of the study, it was not possible to exclude participants from the study
Selective reporting (reporting bias)
Low risk
All reports are given in the measurement method section
Other biases
This study was performed at the orthodontic clinic of the University of Alfonso X in Madrid No funding was provided for this study
Study design: retrospective study Trial location: France
Participants
Number of participants: 22 participants, mean age was years Eligibility criteria: participants had used a rigid or semirigid device for more than six months. The medical record contained a film around the skull before the device was inserted, which is a document showing the initial AHI.
Intervention
9 people in the semirigid MAD group and 13 people in the rigid MAD group
Outcome
Primary outcome: reduce overbite and overjet with semirigid MAD Secondary outcome: showed statistically significant differences in dental analysis but insignificant differences in skeletal analysis.
Notes
Ethics approval: not reported
Risk of bias
Bias
Authors’ judgment
Support for judgment
Random sequence generation (selection bias)
High risk
Allocation was not random
Allocation concealment (selection bias)
High risk
Subjects were paired according to the type of MAD device
Blinding of participants and personnel (performance bias)
High risk
There was no possibility of blinding
Blinding of outcome assessor (detection bias)
Unclear
Blinding is not explained
Incomplete outcome data (attrition bias)
Low risk
Due to the retrospective nature of the study, it was not possible to exclude participants from the study
Selective reporting (reporting bias)
Low risk
All the prespecified outcomes in the method section were addressed adequately
Other biases
This study was performed in the Department of Oral and Maxillofacial Surgery at the Teaching Hospital of the University of Lille, France. The authors declare that they have no competing interest.
Study design: prospectively study Trial location: Sweden
Participants
Number of participants: 77 participants Eligibility criteria: having OSA problems and snoring, sufficient teeth for maintaining MPD, good dental health, and maximum ability to exhaust at least 6 mm using George Gauge®
Intervention
41 users of PMD, 19 people discontinued PMD
Outcome
Primary outcome: reduce overjet in both groups Secondary outcome: reduction of overjet and overbite in PMD discontinuation group
Notes
Ethics approval: The baseline study was approved by the Medical Ethics Committee at Örebro Medical Centre Hospital, Örebro, Sweden.
Risk of bias
Bias
Authors’ judgment
Support for judgment
Random sequence generation (selection bias)
High risk
Allocation was not random
Allocation concealment (selection bias)
High risk
Use of MPD handles in participants with OSA
Blinding of participants and personnel (performance bias)
Low risk
17 people were excluded from the study after 10 years of follow-up
Blinding of outcome assessor (detection bias)
Low risk
Blinding is not explained
Incomplete outcome data (attrition bias)
Low risk
The method section’s predetermined outcomes were all appropriately addressed.
Selective reporting (reporting bias)
Low risk
The method section’s predetermined outcomes were all appropriately addressed.
Other biases
No funds provided for this study. Verification of ethics has been obtained, but the ethics code has not been taken. There was no balance of interest. Informed consent form was signed at the 10-year follow-up, following approval by the Regional Ethics Review Board in Uppsala, Sweden.
Study design: prospectively study Trial location: Italy
Participants
Participants: 82 participants Eligibility criteria: age over 18 years of age, having apnea-hypopnea index (AHI) higher than 5
Intervention
41 people in the OSA group and 41 people in the control group
Outcome
Primary outcome: The groups differ in TMD, pain, and joint disorder Secondary outcome: No association was found between temporomandibular (TMD) disorders and OSA
Notes
Ethics approval: Gemelli Hospital approved the protocol with number 7372/18 before starting the trial
Risk of bias
Bias
Authors’ judgment
Support for judgment
Random sequence generation (selection bias)
High risk
The distribution was not arbitrary.
Allocation concealment (selection bias)
High risk
Subjects were matched in one group based on age, sex, and hospitalization in the ENT department or referring to the oral clinic.
Blinding of participants and personnel (performance bias)
High risk
There was no possibility of blinding
Blinding of outcome assessor (detection bias)
Low risk
Blinding is not explained
Incomplete outcome data (attrition bias)
Low risk
The method section’s predetermined outcomes were all suitably addressed.
Selective reporting (reporting bias)
Low risk
The method section’s predetermined outcomes were all suitably addressed.
Other biases
There has been no funding given for this investigation. The ethics board has given approval. A conflict of interest will not matter.
