Skip to main content
OpenTrials
Completed

NCT Number: NCT06660771

Evaluation of Functional Orthodontic Treatment on Sleep Quality

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sleep Apnea Syndromes in Children Apnea Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Dyssomnias Functional Orthodontic Treatment Jaw Abnormalities Jaw Diseases Mandibular Retrognathia Maxillofacial Abnormalities Micrognathism Musculoskeletal Abnormalities Musculoskeletal Diseases Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Stomatognathic Diseases Stomatognathic System Abnormalities Upper Airway

Age range

11 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gökçenur Gökçe Kara

Istanbul, Maltepe, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Functional orthodontic treatment

Procedure

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.

Primary outcomes

  1. Correction of mandibular retrognathia

    Time frame: Following 6-8 months active treatment

    A normal or corrected overjet in the retracted position

Secondary outcomes

  1. Polygraphic assessment of sleep parameters

    Time frame: Following 6-8 months active treatment

    Changes in apnea hypopnea index (AHI)

  2. Polygraphic assessment of sleep parameters

    Time frame: Following 6-8 months active treatment

    Changes in number of apnea and hypopnea

  3. Polygraphic assessment of sleep parameters

    Time frame: Following 6-8 months active treatment

    Changes in number of hypopnea

  4. Polygraphic assessment of sleep parameters

    Time frame: Following 6-8 months active treatment

    Changes in desaturation index

  5. Polygraphic assessment of sleep parameters

    Time frame: Following 6-8 months active treatment

    Changes in lowest desaturation

  6. Polygraphic assessment of sleep parameters

    Time frame: Following 6-8 months active treatment

    Changes in average saturation

  7. Polygraphic assessment of sleep parameters

    Time frame: Following 6-8 months active treatment

    Changes in the value of Supin AHI

Sponsors and collaborators

Lead sponsor

Gökçenur Gökçe Kara

Other

Collaborators

  • Ege University
  • Izmir Katip Celebi University

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Oct 28, 2024
Registry last updated
Oct 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.