Single Palatal Temporary Anchorage Device for Anterior Open Bite

NCT04419805 | Active Not Recruiting

• 1 other identifier: 2-054-19
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Conditions

Anterior Openbite

Keywords

Orthodontics; Temporary Anchorage Device; Anterior Open Bite

Outcome Measures

Primary Outcomes (1)

• Molar intrusion

  Amount of upper molar intrusion measured in mms on cephalometric radiograph

  9-12 months after treatment commences

Secondary Outcomes (2)

• Overbite (vertical overlap of anterior teeth)

  9-12 months after treatment commences

• Patient Experience

  9-12 months after treatment commences

Study Arms (2)

Single Palatal TAD

EXPERIMENTAL

Single Palatal TAD for orthodontic molar intrusion

Device: Single Palatal TAD

Two buccal TADs

EXPERIMENTAL

Two buccal TADs for orthodontic molar intrusion

Device: Two buccal TADs

Interventions

Single Palatal TAD DEVICE

A single mini-screw inserted in the mid-palate

Single Palatal TAD

Two buccal TADs DEVICE

Two buccal TADs inserted in the upper jaw

Two buccal TADs

Eligibility Criteria

• Age: 12 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Dundee: lead

Study Sites (1)

Dundee Dental Hospital

Dundee, DD1 4HR, United Kingdom

Location

Related 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.

  PMID: 27864320 BACKGROUND

Study Officials

• Peter Mossey, BDS

  University of Dundee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessor will be blind to allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomised parallel 2 group clinical trial

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: June 5, 2020
• Study Start: April 1, 2021
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)