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Active, not recruitingNCT04419805SPaTARUpdated Apr 20, 2026

Single Palatal Temporary Anchorage Device for Anterior Open Bite

An interventional study of Single Palatal TAD and Two buccal TADs in Anterior Openbite, sponsored by University of Dundee. Active, not recruiting at 1 site in United Kingdom. Open to participants aged 12 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-04-20.

Sponsored by University of Dundee · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
12 Years to 40 Years
Sex
All
01

Study 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

Read the 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

02

Conditions studied

  • Anterior Openbite

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Keywords

  • Orthodontics
  • Temporary Anchorage Device
  • Anterior Open Bite
03

In context

Open Bite

34 studies on the registry are indexed under Open Bite; 8 are open to participants now.

This study's planned enrollment of 32 is close to the median of 30 across 28 interventional studies indexed under Open Bite.

Browse Open Bite studies →

Lead sponsor

University of Dundee is the lead sponsor of 113 studies on the registry; 3 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
32 participants (estimated)

Study arms

  • Experimental
    Single Palatal TAD

    Single Palatal TAD for orthodontic molar intrusion

    Device: Single Palatal TAD

  • Experimental
    Two buccal TADs

    Two buccal TADs for orthodontic molar intrusion

    Device: Two buccal TADs

Interventions

  • DeviceSingle Palatal TAD

    A single mini-screw inserted in the mid-palate

  • DeviceTwo buccal TADs

    Two buccal TADs inserted in the upper jaw

06

What researchers measure

Primary outcomes

  1. Molar intrusion

    Amount of upper molar intrusion measured in mms on cephalometric radiograph

    Time frame: 9-12 months after treatment commences

Secondary outcomes

  1. 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

    Time frame: 9-12 months after treatment commences

  2. 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)

    Time frame: 9-12 months after treatment commences

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Study locations

1 site
  • Dundee Dental Hospital
    Dundee, DD1 4HR, United Kingdom
08

References and documents

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. PubMed 27864320 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04419805
Responsible party
Peter Mossey (Professor, University of Dundee) — Principal investigator
First posted
Jun 5, 2020
Start date
Apr 1, 2021
Primary completion
Oct 30, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Apr 20, 2026

Study contacts

Peter Mossey, BDS
principal investigator · University of Dundee

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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