Orthodontic-orthopedic devices for maxillary expansion assessed in Spain

In January 2019, the Health Institute Carlos III published a report titled “Efficiency and safety analysis of orthodontic-orthopedic devices for maxillary expansion as an alternative to adenotonsillectomy and/or pharmacological treatment for Pediatric Obstructive Sleep Apnea-Hypopnea Syndrome (OSAHSp).”

OSAHSp is associated with difficulties in sleep and changes in daytime behavior. The syndrome can involve critical clinical consequences such as endothelial damage and cardiovascular alterations, endocrine-metabolic complications and neurocognitive problems. The syndrome leads to a decrease in the quality of life of both the child and his family. The prevalence of OSAHSp ranges from 2% to 4% in children from 2 to 6 years of age, affecting both sexes. The etiology is multifactorial and anatomical, functional and genetic factors influence the pathological process. The diagnosis of OSAHS in children is sometimes complex.

The management options of OSAHSp includes different therapeutic alternatives. Although adenotonsillectomy is the most frequent treatment. There are other options: the use of continuous positive pressure in the upper airway, pharmacological treatment, mandibular advancement devices, and orthodontic-orthopedic treatments with maxillary expanders. In the latter case, this is related to the fact that specific craniofacial and dental features can be associated with chronic airway flow obstruction typical of OSAHS in children.

The objective of this study is to analyze the efficacy and safety of orthodontic-orthopedic devices for maxillary expansion versus adenotonsillectomy and/or pharmacological treatment for the treatment of pediatric OSAHS.

A systematic review (SR) of the scientific literature was carried out in the main medical databases. Furthermore, a search for the grey literature and websites of national and international health technology assessment agencies was also carried out. Moreover, it was performed a hand search to identify additional literature from the references founds. The search was not restricted to any language or sample size of studies designs, and it included patients under 18 years with sleep apnea-hypopnea syndrome (SAHS) until of May 15, 2017. The identification, selection, and review of the studies were carried out by two reviewers independently.

Results:

• Methodology:
  • After a review of the articles, 5 met inclusion criteria: 1 clinical trial and 4 SRs with meta-analysis. The trial, included in one of the reviews, was selected as the only study found that responds to the objective of our review (patients treated with RME versus those treated with ATT)
• Effectiveness results:
  • 21 studies are analyzed in the included SRs (some of them included in more than one SR). The clinical trial includes 52 patients. The study population were patients with SAHSp and a mean age of 5.02 ± 2.03 years. The 4 SRs include among 5 and 17 clinical trials, and the number of patients ranges from 123 to 314. The study population were, in general, children under 18 years of age. The intervention consisted of RME treatment using different types of devices, with some differences in anchoring and inactivation protocol. The follow-up period varied from 1 month to more than 3 years
  • The 52 patients of the clinical trial were non-randomly distributed in two study groups. One group was treated with ATT (group I) and the other group was treated with RME (group II). The parameters were analyzed at the beginning of the study (T0) and at 12 months (T1). A significant decrease in apnea-hypopnea index (AHI) was observed in the two groups (group I: 17,25 ± 13,94 vs. 1,79 ± 1,82events / hour at T0 and T1 respectively, p = 0.000, group II: 5.81 ± 6.05 vs. 2.64 ± 3.11 events / hour at T0 and T1 respectively, p = 0.005); and an increase in mean oxygen saturation during night (group I: 96.11 ± 2.68 vs 97.50 ± 1.14 at T0 and T1 respectively, p = 0.013, group II: 96.56 ± 1, 47 vs 97.42 ± 1.84 at T0 and T1 respectively, p = 0.013)
• Safety results:
  • The clinical trial shows that parents of patients don’t report adverse side effects after receiving treatment. The 4 RSs don’t provide data in relation to the safety of RME treatment
• Results of biases assessment and quality of the studies:
  • According to the tool proposed by the Cochrane Collaboration, the clinical trial has a high risk of selection bias because it doesn’t generate or hide the randomization sequence. It also presents a high risk of performance bias since there is no masking of researchers or participants, and it has a high risk of detection bias due to the lack of masking of results evaluation. Regarding the quality of the reviews, 2 of them meet the 11 items described in the AMSTAR scale, so they could be considered of good quality

Conclusions:

• This report aims to evaluate treatment with RME versus ATT and/or pharmacological treatment for SAHSp. However, only found one non-randomized clinical trial that analyzes the treatment with RME and with ATT was found
• In relation to the efficacy of the treatment with RME, it was found that such treatment improves the AHI in children with SAHS, although there isn’t enough information about long-term results
• The information on other clinical variables of RME treatment results is very poor, and quality of life studies for patients after treatment were not found
• In relation to the safety of the RME, the studies don’t report side effects to the treatment or don´t state the absence of complications. Although it would be convenient to have more information, it is believed that the safety of RMEs is not a relevant problem
• The studies have limitations in relation, above all, to the lack of randomization and the absence of a comparator. They also show a high heterogeneity, so the results on the effectiveness of RME should be interpreted cautiously
• It is considered fundamental to carry out well-designed research studies. To study the effectiveness of RME in relation to other therapeutic alternatives and to know which patients could benefit more from the intervention would be of special interest

See the full report in Spanish with a summary in English here

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