NCT06660771

Evaluation of Functional Orthodontic Treatment on Sleep Quality

Polygraphic Evaluation of the Effects of Functional Orthodontic Treatment with Twin Block and Herbst Appliances on Sleep Quality: a Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Gökçenur Gökçe Kara · Academic / Other
• Sex: All
• Age: 11 Years – 15 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Sleep Apnea Syndromes in Children
• Functional Orthodontic Treatment
• Mandibular Retrognathia
• Upper Airway

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-05-05
• Primary completion: 2024-01-28
• Completion: 2024-05-28
• First posted: 2024-10-28
• Last updated: 2024-10-28

Locations

1 site across 1 country: Turkey (Türkiye)