An interventional study of Functional orthodontic treatment in Sleep Apnea Syndromes in Children, Functional Orthodontic Treatment and Mandibular Retrognathia, sponsored by Gökçenur Gökçe Kara. Completed at 1 site in Turkey. Open to participants aged 11 Years to 15 Years. Per ClinicalTrials.gov, last updated 2024-10-28.
Sponsored by Gökçenur Gökçe Kara · Not applicable, Interventional, and Treatment
Functional appliances are used in the treatment of Class II anomalies caused by mandibular rethrognathia. Herbst which is a fixed and rigid functional appliance and TWB which is removable appliance can be successful in the treatment of mandibular retrognathia in a short period of six to eight months during the pubertal growth phase. An increase in the upper airway size occurs as a result of functional orthopedic treatment devices eliminating the problem of mandibular retrognathia and stimulating mandibular growth. The aim of this randomized controlled trial was to evaluate the effects of TWB and Herbst appliances on sleep quality in children with obstructive sleep apnea. The null hypothesis was that there is no difference for the sleep quality between the appliances.
Introduction: This multicenter clinical study aimed to investigate the effects of twin block (TB) and Herbst functional appliances on sleep quality in children with OSAS and mandibular retrognathia. Methods: A total of 46 patients having mandibular retrognathia and identified with OSA were divided randomly into two groups: twin block (TB) and Herbst functional appliances. Changes in sleep parameters at baseline and an avarage of 8-month follow-up detected by polygraphy and Pittsburg Sleep Quality Index (PSQI) were the primary outcome. Treatment of the mandibular retrognathia was the secondary outcome. hapiro Wilk test and Q-Q graphs were used to examine the distribution assumptions of continuous variables according to groups. Mann Whitney U test was used to evaluate two independent group means or distributions of continuous measurements. Paired sample t test or Wilcoxon signed rank test was used to evaluate the differences between the baseline and follow-up times at p \< 0.05 significance level.
26 studies on the registry are indexed under Micrognathism; 7 are open to participants now.
This study's enrollment of 46 is above the median of 24 across 22 interventional studies indexed under Micrognathism.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The Herbst appliance is fixed and rigid functional appliance. It consists of attachments (casted splints) in the lateral segments of both jaws which are connected by a telescoping mechanism from the upper posterior to the lower anterior region resulting in mandibular bite jumping.
Procedure: Functional orthodontic treatment
Twin-block appliance is used with two separate acrylic plates for the lower and upper jaw. It consists of acrylic bite blocks that lock together at a 70° angle, allowing the mandible to be positioned in front.
Procedure: Functional orthodontic treatment
The patients were treated with Twin block and Herbst functional appliances. Alginate impressions and a protrusive wax bite were taken for the construction of each appliance. Each device was fitted and then reviewed 4-6 weeks later. First group was treated with Twin block which was manufactured basically according to the original design described by Clark. The overjet was measured from the patients in centric relationship and maximum protrusion position, and construction bite was recorded with 70% of the total advancement capacity of the mandible and 2-4 mm above the freeway space vertically. Overjet measurements were made at each session and active treatment was terminated when a normal overjet in the retracted position was recorded. Second group was treated with the stainless-steel crown Herbst appliance, included crowned maxillary first molars and mandibular first premolars. The construction bite was recorded with the mandible forward by edge-to-edge incisor position.
Correction of mandibular retrognathia
A normal or corrected overjet in the retracted position
Time frame: Following 6-8 months active treatment
Polygraphic assessment of sleep parameters
Changes in apnea hypopnea index (AHI)
Time frame: Following 6-8 months active treatment
Polygraphic assessment of sleep parameters
Changes in number of apnea and hypopnea
Time frame: Following 6-8 months active treatment
Polygraphic assessment of sleep parameters
Changes in number of hypopnea
Time frame: Following 6-8 months active treatment
Polygraphic assessment of sleep parameters
Changes in desaturation index
Time frame: Following 6-8 months active treatment
Polygraphic assessment of sleep parameters
Changes in lowest desaturation
Time frame: Following 6-8 months active treatment
Polygraphic assessment of sleep parameters
Changes in average saturation
Time frame: Following 6-8 months active treatment
Polygraphic assessment of sleep parameters
Changes in the value of Supin AHI
Time frame: Following 6-8 months active treatment
Plan to share: Undecided
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