Evaluation of Functional Orthodontic Treatment on Sleep Quality

Gökçenur Gökçe Kara

Status: Completed

Conditions: Mandibular Retrognathia; Sleep Apnea Syndromes in Children; Functional Orthodontic Treatment; Upper Airway

Treatments: Procedure: Functional orthodontic treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT06660771

M01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 11 to 15 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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46 participants in 2 patient groups

Herbst

Experimental group

Description:

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.

Treatment:

Procedure: Functional orthodontic treatment

Twin Block

Experimental group

Description:

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.

Treatment:

Procedure: Functional orthodontic treatment