Preferred Reporting Items for Systematic review and Meta-Analysis (PRISMA) checklist was used as a template for this review.
2.1 Protocol and registration: Not available
2.2 Eligibility criteria:
participants, interventions, comparators, and outcomes (PICO) was used to formulate the review objective and inclusion criteria
participant: children up to 18 years old.
interventions: any type of oral appliance as the primary treatment, use of oral appliance in conjunction with other treatment modalities, comparison between different types of oral appliances, comparison between oral appliances and other treatment modalities.
comparators: treatment vs control group, treatment vs different type of treatment, before vs after treatment.
Outcome: primary outcome reduction of AHI, secondary outcomes: significant changes in other sleep parameters (e.g.: oxygen saturation, arousal index), craniodental changes, daytime and nocturnal symptoms.
Included studies: randomized controlled trials RCT, clinical studies both randomized and nonrandomized either retrospective or prospective.
due to the limited number of published RCT in the literature other types of clinical studies were included. pilot, preliminary and case report studies were not included due to limited sample size and higher risk of bias.
Studies publish in English from the year 2000 to May 2019.
2.3 Exclusion criteria:
Studies that includes adults in its sample, Studies that evaluate the use of other modalities in the treatment of OSA in children and Studies including a specific sample group: children with syndromes or systemic disorders.
2.4 Information sources
Systemic research of electronic databases: PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), international Registry Platform for ongoing trials and clinical trails.gov, Embase Ovid, Medline complete.
RCT, NRCT, prospective and retrospective clinical studies that uses an oral appliance as a primary treatment or in conjunction with other treatment modalities and uses AHI to measure the effectiveness of the intervention were included in this review
Studies publish in English langue from 2000-May 2019
The last search was done on 27th of May 2019
The search was done independently in duplication by 2 reviewers (Norah Alotaibi and Amani Alkhamees) and any disagreement between the reviews was dissolved by the supervisor (Rabia Bilal).
Search words were a combination of: “oral appliances/ oral device/ orthodontics/mandibular advancement appliance/ maxillary expansion” and “obstructive sleep apnea or obstructive sleep apnea or OSA” and “children/pediatric”
For PubMed the following limits were set: study type: controlled clinical trials, randomized control trails
custom date range 01-01-2000 to 25-05-2019, language: English, Age: child: birth- 18 years
For Medline complete the following limits were set: Date (2000-2019), language: English, age: all child:0-18
For Cochrane Central Register of Controlled Trials (central) the following limits were set: year (2000-2019), Trails
For Embase Ovid the search was done using the multifield feature was used and the following limits were set: publication year (2000-current), Age group (All child 0 to 18), languages (English), publication type (clinical trial), publication types (clinical trials, ALL).
2.6 Study selection
Database search was done for possible studies, abstracts of the studies were screened for identification of eligible studies, Full text articles were obtained and assessed and a final list of included studies was made.
This process was done independently and in duplication by 2 reviewers and any disagreement was resolved by the 3rd reviewer
References were organized and managed using Mendeley desktop (version 1. 19. 4)
2.7 Data collection process
We developed a form based on the Cochrane Consumers and Communication Review Group’s data extraction template and followed it for each study.
Two reviewers collected the data independently collected data was combined and compared for accuracy any discrepancies were solved by a third reviewer.
2.8 Data items
Data collected from the selected studies included: study design, study population (sample size, age, diagnosis, method of diagnosis, pre intervention records), intervention applied (type, duration of treatment and follow up), outcomes (primary outcome: changes in AHI, secondary outcome: changes in oxygen saturation, craniofacial and dental changes, reported symptoms changes)
2.9 Risk of bias in individual studies
Risk of bias assessment was done following The Cochrane Risk of Bias criteria. The assessment was done by two reviewers independently and in duplication and any discrepancies were resolved by the third reviewer.
2.10 Summary measures
primary outcome reduction of AHI, secondary outcomes: other significant changes in sleep parameters, craniodental changes, daytime and nocturnal symptoms.
2.11 Synthesis of results:
Due to the difference in the included studies: study designs, lack of control groups in some studies, sample size, type of intervention used, duration of treatment, duration of follow up meta-analysis was not be conducted.