Single Palatal Temporary Anchorage Device for Anterior Open Bite

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2025-12-30

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

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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

Conditions

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Anterior Openbite

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised parallel 2 group clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Outcome assessor will be blind to allocation

Study Groups

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Single Palatal TAD

Single Palatal TAD for orthodontic molar intrusion

Group Type EXPERIMENTAL

Single Palatal TAD

Intervention Type DEVICE

A single mini-screw inserted in the mid-palate

Two buccal TADs

Two buccal TADs for orthodontic molar intrusion

Group Type EXPERIMENTAL

Two buccal TADs

Intervention Type DEVICE

Two buccal TADs inserted in the upper jaw

Interventions

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Single Palatal TAD

A single mini-screw inserted in the mid-palate

Intervention Type DEVICE

Two buccal TADs

Two buccal TADs inserted in the upper jaw

Intervention Type DEVICE

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

Minimum Eligible Age

12 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No