Anterior Openbite
Conditions
Keywords
Orthodontics, Temporary Anchorage Device, Anterior Open Bite
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
Interventions
DEVICESingle Palatal TAD
A single mini-screw inserted in the mid-palate
DEVICETwo buccal TADs
Two buccal TADs inserted in the upper jaw
Sponsors
University of Dundee
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessor will be blind to allocation
Intervention model description
Randomised parallel 2 group clinical trial
Eligibility
Sex/Gender
ALL
Age
12 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Molar intrusion | 9-12 months after treatment commences | Amount of upper molar intrusion measured in mms on cephalometric radiograph |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
United Kingdom
Contacts
PRINCIPAL_INVESTIGATORPeter Mossey, BDS
University of Dundee
Outcome results
None listed