Dundee Dental Hospital
Dundee, DD1 4HR, United Kingdom
NCT Number: NCT04419805
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
This study is active but is not currently recruiting participants.
Notify Me12 year–40 year
All sexes
Interventional
Not applicable
Dundee, DD1 4HR, United Kingdom
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A single mini-screw inserted in the mid-palate
Two buccal TADs inserted in the upper jaw
Time frame: 9-12 months after treatment commences
Amount of upper molar intrusion measured in mms on cephalometric radiograph
Time frame: 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
Time frame: 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)
University of Dundee
Other
Single Palatal Temporary Anchorage Device for Anterior Open Bite: a Randomized Clinical Trial
Acronym: SPaTAR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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