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Evaluation of Functional Orthodontic Treatment on Sleep Quality

NCT06660771 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2024-10-28

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Izmir Katip Celebi University

    collaborator OTHER

  • Ege University

    collaborator OTHER

  • Gökçenur Gökçe Kara

    lead OTHER

Principal Investigators

  • Gökçenur Gökçe Kara · Marmara University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
11 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-05
Primary Completion
2024-01-28
Completion
2024-05-28

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06660771 on ClinicalTrials.gov