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Clinical Trials/NCT04419805
NCT04419805Active, not recruitingNot Applicable

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

University of Dundee2 sites in 1 country32 target enrollmentStarted: April 1, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
32
Locations
2
Primary Endpoint
Molar intrusion

Study Overview

Brief 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

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Masking Description

Outcome assessor will be blind to allocation

Eligibility Criteria

Ages
12 Years to 40 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Single Palatal TAD

Experimental

Single Palatal TAD for orthodontic molar intrusion

Intervention: Single Palatal TAD (Device)

Two buccal TADs

Experimental

Two buccal TADs for orthodontic molar intrusion

Intervention: Two buccal TADs (Device)

Outcomes

Primary Outcomes

Molar intrusion

Time Frame: 9-12 months after treatment commences

Amount of upper molar intrusion measured in mms on cephalometric radiograph

Secondary Outcomes

  • Overbite (vertical overlap of anterior teeth)(9-12 months after treatment commences)
  • Patient Experience(9-12 months after treatment commences)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Peter Mossey

Professor

University of Dundee

Study Sites (2)

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