Single Palatal Temporary Anchorage Device for Anterior Open Bite

Not Applicable

Recruiting

• Conditions: Anterior Openbite
• Interventions: Device: Two buccal TADs; Device: Single Palatal TAD

• Registration Number: NCT04419805
• Lead Sponsor: University of Dundee

Brief Summary

Participants are orthodontic patients with anterior open bite (AOB) malocclusion. These patients will be treated by molar intrusion achieved using one of two interventions, either orthodontic fixed appliances incorporating a single palatal Temporary Anchorage Device (TAD) or orthodontic fixed appliances incorporating two buccal TADs

Detailed Description

Participants will be recruited from those attending Dundee Dental Hospital Orthodontic Department and those currently awaiting treatment. Those that meet the inclusion and exclusion criteria will be invited to participate. After obtaining consent they will be allocated to receive one of the two interventions. The two interventions represent the currently available options for treatment of mild - moderate (1-6mm) anterior open bite in the Orthodontic Department and as such patients will be receiving routine treatment regardless of the arm they are randomised to. In order to assess the more effective intervention additional records will be taken during the treatment involving additional cephalometric radiographs, additional intra-oral scans or dental impressions (See later for details). Primary outcome is at the end of intrusion with TADs after 9-12 months, but participants will be followed until completion of treatment for the secondary outcome of stability of intrusion and overbite correction

Study Timeline

• Study First Submitted: 2020-05-29
• Study First Submitted QC: 2020-06-04
• Study First Posted: 2020-06-05
• Study Start: 2021-04-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-08
• Last Update Posted: 2024-02-12
• Primary Completion: 2025-10-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Patients with AOB of 1-6mm
• Aged between (12 and 40 years).
• Able to consent.
• Patient due to undergo orthodontic treatment with fixed orthodontic braces.

Exclusion Criteria

• Patient has previously had upper first permanent molar extraction.
• Patient with congenital cleft of lip and/or palate or any other craniofacial anomalies.
• Patient with bone disease or taking medications that affect the bone quality or nature.
• Patient with an active digit sucking habit.
• Pregnant or breastfeeding women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Two buccal TADs	Two buccal TADs	Two buccal TADs for orthodontic molar intrusion
Single Palatal TAD	Single Palatal TAD	Single Palatal TAD for orthodontic molar intrusion

Primary Outcome Measures

Name	Time	Method
Molar intrusion	9-12 months after treatment commences	Amount of upper molar intrusion measured in mms on cephalometric radiograph

Secondary Outcome Measures

Name	Time	Method
Overbite (vertical overlap of anterior teeth)	9-12 months after treatment commences	Change in overbite (vertical overlap of anterior teeth) measured clinically directly from the teeth with a ruler and on 3D dental scans using 3D analysis software, both in mms
Patient Experience	9-12 months after treatment commences	Patient experience with the use of temporary anchorage devices for intrusion by validated questionnaire which uses 3 or 4 point Likert Scales for a range of questions across relevant doamins. Depending on the question the scales are 'Improved/Same/Worse/Much worse' or 'Not at all / A little / A lot' or 'I do more / no difference / I do less' (Yassir et al 2017)

Trial Locations

Locations (1)

Dundee Dental Hospital; 🇬🇧 Dundee, United Kingdom