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NCT06660771

Evaluation of Functional Orthodontic Treatment on Sleep Quality

Completed NA Last updated 28 October 2024
What this trial tests

NA trial testing Functional orthodontic treatment in Sleep Apnea Syndromes in Children in 46 participants. Completed in 28 May 2024.

Timeline
5 May 2021
Primary endpoint
28 January 2024
28 May 2024

Quick facts

Lead sponsorGökçenur Gökçe Kara
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment46
Start date5 May 2021
Primary completion28 January 2024
Estimated completion28 May 2024
Sites1 location across Turkey (Türkiye)

Drugs / interventions tested

Conditions studied

Sponsor

Gökçenur Gökçe Kara

Who can join

Adults 11 to 15, any sex, with Sleep Apnea Syndromes in Children or Functional Orthodontic Treatment. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing