Single Palatal TAD for Anterior Open Bite: a RCT
Research type
Research Study
Full title
Single Palatal Temporary Anchorage Devices (TADs) for Anterior Open Bite (AOB): a Randomised Clinical Trial (RCT).
IRAS ID
258241
Contact name
Peter Mossey
Contact email
Sponsor organisation
Tayside Medical Science Centre -Ninewells Hospital & Medical School
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
3 years, 1 months, 19 days
Research summary
Participants who have a gap between the upper and lower front teeth will be recruited from those attending Dundee Dental Hospital Orthodontic Department and those currently awaiting treatment. Those that meet the full inclusion and exclusion criteria will be invited to participate. The patients who are eligible for the trial but not interested in taking part will be treated according to normal departmental clinical protocol. Patients who for any reason are found not to meet the inclusion criteria will still be offered orthodontic treatment according to a normal departmental clinical protocol.
After obtaining consent they will be allocated to receive one of the two interventions. The two interventions represent two of the currently available options for treatment of anterior open bite (where front teeth do not meet) in the Orthodontic Department and as such patients will be receiving routine treatment regardless of the arm they are randomised to. The two groups are treated using a temporary mini screw placed in the roof of the mouth or two temporary mini screws, one on each side of the mouth. To assess the more effective of these two interventions, additional records will be taken during the treatment involving an additional dental (cephalometric) radiograph, additional digital scans of the teeth and patient questionnaires.
After 9-12 months, the primary outcome will be recorded in terms of how much the gap between the upper and lower front teeth has reduced, and the participants will be followed until completion of the orthodontic treatment for the secondary outcome of stability of the changes achieved.REC name
East of Scotland Research Ethics Service REC 2
REC reference
20/ES/0043
Date of REC Opinion
17 Nov 2020
REC opinion
Further Information Favourable Opinion