Single Palatal Temporary Anchorage Device for Anterior Open Bite

Anterior Openbite Clinical Trial

— SPaTAR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04419805
• Other study ID #: 2-054-19
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: December 30, 2025

Study information

• Verified date: February 2024
• Source: University of Dundee
• Contact: David Bearn, BDS
• Phone: 01382385024
• Email: d.bearn[@]dundee.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: December 30, 2025
• Est. primary completion date: October 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Openbite
• Open Bite

Intervention

Device:
• Single Palatal TAD
A single mini-screw inserted in the mid-palate
• Two buccal TADs
Two buccal TADs inserted in the upper jaw

Locations

Country	Name	City	State
United Kingdom	Dundee Dental Hospital	Dundee

Sponsors (1)

Lead Sponsor	Collaborator
University of Dundee

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Yassir YA, McIntyre GT, Bearn DR. Three questionnaires to assess the perception of fixed orthodontic therapy before, during and after treatment: validity and reliability. Eur J Orthod. 2017 Aug 1;39(4):402-410. doi: 10.1093/ejo/cjw076. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Molar intrusion	Amount of upper molar intrusion measured in mms on cephalometric radiograph	9-12 months after treatment commences
Secondary	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
Secondary	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