Single Palatal Temporary Anchorage Device for Anterior Open Bite (SPaTAR)

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Anterior Openbite
• Intervention / Treatment: Device: Single Palatal TAD; Device: 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

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Dundee, United Kingdom, DD1 4HR
    • Dundee Dental Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Palatal TAD; Single Palatal TAD for orthodontic molar intrusion	Device: Single Palatal TAD; A single mini-screw inserted in the mid-palate
Experimental: Two buccal TADs; Two buccal TADs for orthodontic molar intrusion	Device: Two buccal TADs; Two buccal TADs inserted in the upper jaw

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Molar intrusion	Amount of upper molar intrusion measured in mms on cephalometric radiograph	9-12 months after treatment commences

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Dundee
• Investigators: Principal Investigator: Peter Mossey, BDS, University of Dundee

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: May 29, 2020
• First Submitted That Met QC Criteria: June 4, 2020
• First Posted (Actual): June 5, 2020

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Orthodontics; Temporary Anchorage Device; Anterior Open Bite
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion; Open Bite
• Other Study ID Numbers: 2-054-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No