Clinical trial NCT06660771: Evaluation of Functional Orthodontic Treatment on Sleep Quality
Official title: Polygraphic Evaluation of the Effects of Functional Orthodontic Treatment with Twin Block and Herbst Appliances on Sleep Quality: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea Syndromes in Children
Functional Orthodontic Treatment
Mandibular Retrognathia
Upper Airway
Keywords: Obstructive sleep apnea
Herbst
Twin Block
Lead sponsor: Marmara University
Sponsor class: OTHER
Collaborators: name: Izmir Katip Celebi University
name: Ege University
First posted: 2024-10-28
Enrollment: 46
Sex: ALL
Minimum age (years): 11
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2-arm parallel trial
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* no prior orthodontic treatment, nasal, tonsillar, or adenoid surgery
* absence of any oral, nasal or systemic disease
* the existence of skeletal Class II and dental Class II Division 1 malocclusion (ANB \>4°; SNB \<80°; incisor overjet \>3 mm)
* requiring functional orthodontic treatment
* Individuals are in the MP3cap and S period according to hand-wrist films, and in the CS3 and CS4 period using the CVM method
* patients with OSA (apnea/hypopnea index (AHI)\>1/h

Exclusion Criteria:

* body mass index (BMI) ≥ 30 (weight (kg)/height (m2))
* the presence of nasopharyngeal pathologies, craniofacial anomalies, , systemic disorder, or weak oral hygiene
* history of previous orthodontic treatment

Primary outcomes:
measure: Correction of mandibular retrognathia
timeFrame: Following 6-8 months active treatment
Secondary outcomes:
measure: Polygraphic assessment of sleep parameters
timeFrame: Following 6-8 months active treatment
measure: Polygraphic assessment of sleep parameters
timeFrame: Following 6-8 months active treatment
measure: Polygraphic assessment of sleep parameters
timeFrame: Following 6-8 months active treatment
measure: Polygraphic assessment of sleep parameters
timeFrame: Following 6-8 months active treatment
measure: Polygraphic assessment of sleep parameters
timeFrame: Following 6-8 months active treatment
measure: Polygraphic assessment of sleep parameters
timeFrame: Following 6-8 months active treatment
measure: Polygraphic assessment of sleep parameters
timeFrame: Following 6-8 months active treatment
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Gökçenur Gökçe Kara
state: Maltepe
Study officials:
affiliation: Marmara University
name: Gökçenur Gökçe Kara
role: PRINCIPAL_INVESTIGATOR
References: