Single Palatal Temporary Anchorage Device for Anterior Open Bite

Study Overview
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Brief Summary
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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
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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

Official Title
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Single Palatal Temporary Anchorage Device for Anterior Open Bite: a Randomized Clinical Trial

Conditions
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Anterior Openbite

Intervention / Treatment
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* Device: Single Palatal TAD
* Device: Two buccal TADs


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised parallel 2 group clinical trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Palatal TAD<br>Single Palatal TAD for orthodontic molar intrusion | Device: Single Palatal TAD<br>* A single mini-screw inserted in the mid-palate<br>|
| Experimental: Two buccal TADs<br>Two buccal TADs for orthodontic molar intrusion | Device: Two buccal TADs<br>* Two buccal TADs inserted in the upper jaw<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Molar intrusion | Amount of upper molar intrusion measured in mms on cephalometric radiograph | 9-12 months after treatment commences | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overbite (vertical overlap of anterior teeth) | 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 | 9-12 months after treatment commences | 
| Patient Experience | 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) | 9-12 months after treatment commences | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Orthodontics, Temporary Anchorage Device, Anterior Open Bite