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NCT Number: NCT04419805

Single Palatal Temporary Anchorage Device for Anterior Open Bite

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Age range

12 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dundee Dental Hospital

Dundee, DD1 4HR, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Single Palatal TAD

Device

A single mini-screw inserted in the mid-palate

Two buccal TADs

Device

Two buccal TADs inserted in the upper jaw

Primary outcomes

  1. Molar intrusion

    Time frame: 9-12 months after treatment commences

    Amount of upper molar intrusion measured in mms on cephalometric radiograph

Secondary outcomes

  1. Overbite (vertical overlap of anterior teeth)

    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

  2. Patient Experience

    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)

Sponsors and collaborators

Lead sponsor

University of Dundee

Other

Registry information

Official study title

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

Acronym: SPaTAR

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jun 5, 2020
Registry last updated
Apr 20, 2026

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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