Evaluation of Functional Orthodontic Treatment on Sleep Quality
Launched by GÖKÇENUR GÖKÇE KARA · Oct 25, 2024
Trial Information
Current as of June 21, 2025
Completed
Keywords
ClinConnect Summary
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 seconda...
Gender
ALL
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
About Gökçenur Gökçe Kara
Gökçenur Gökçe Kara is a dedicated clinical trial sponsor with a commitment to advancing medical research and improving patient outcomes. With a focus on innovative therapeutic solutions, the organization emphasizes rigorous study design, ethical practices, and compliance with regulatory standards. Leveraging a collaborative approach, Gökçenur Gökçe Kara works closely with healthcare professionals, research institutions, and regulatory bodies to facilitate the successful execution of clinical trials. Their mission is to contribute to the development of safe and effective treatments, ultimately enhancing the quality of care for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Istanbul, Maltepe, Turkey
Patients applied
Trial Officials
Gökçenur Gökçe Kara
Principal Investigator
Marmara University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported