A Randomized Clinical Trial to Investigate Whether Self Ligating Brackets or Conventional Brackets Are Better for Treating Bimaxillary Proclination

The study is a single blind randomised control trial.The patients will be randomly assigned to have conventional brackets placed or self ligating brackets placed.

All patients will undergo full Orthodontic records. This will include an Orthodontic assesment, study models relevant xrays (orthopantogram and a cephalomgram) and clinical photos. After records analysis, patients will be given a prophylaxis and oral hygiene instructions.

Either 3m Victory Series™ Metal Braces or 3m SmartClip™ SL3 Self-Ligating Braces both bracket types will carry the MBT prescription 0.022 slot height, will be bonded using Transbond™ XT (3M Unitek, Monrovia, California, USA) composite resin according to the manufactuer's instruction.

These patients will be recalled at monthly intervals for the duration of treatment time which will be 3 years. A cephalogram will be taken at the end of treatment

Study Overview

• Status: Unknown
• Conditions: Bimaxillary Proclination
• Intervention / Treatment: Other: Orthodontic Brackets

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Trudee Hoyte; Phone Number: 8686845008; Email: Trudee.Hoyte@sta.uwi.edu
• Study Contact Backup: Name: David Bearn; Phone Number: +441382381604; Email: D.Bearn@dundee.ac.uk

Study Locations

• Trinidad and Tobago
  • Saint Augustine, Trinidad and Tobago
    • Recruiting
    • UWI Dental School
    • Contact: Trudee Hoyte; Phone Number: 8686845008; Email: Trudee.Hoyte@sta.uwi.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 16 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Bimaxillary Proclination
• Class I or Class II division 1 incisor relationship with an overjet less than or equal to 6.0 mm
• The cases can be extraction or non extraction cases
• Extraction cases must be of at least both upper first premolars to relieve moderate to severe crowding and/or to reduce the overjet
• No previous orthodontic treatment
• No systemic illness
• No use of anti inflammatory drugs prior to placement of the fixed appliance
• Good oral hygiene and periodontal health with periodontal pockets of less than or equal to 4 mm, full-mouth plaque score less than or equal to 20 per cent
• Cooperative and motivated
• In the permanent dentition with all teeth present at least to the first molars
• No radiographic bone loss was observed on the dental pantomographic image.

Exclusion criteria:

• Patients who required surgery to correct skeletal discrepancies.
• Patients with hyperdontia, hypodontia, or syndromic diseases (e.g. cleft lip and palate).
• Uncooperative patients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment time	Length of time each bracket takes to treat a bimaxillary proclination patient	18-24 months

Collaborators and Investigators

• Sponsor: The University of The West Indies
• Collaborators: University of Dundee
• Investigators: Principal Investigator: Trudee Hoyte, The University of the West Indies

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 4, 2017
• Primary Completion (ANTICIPATED): May 31, 2021
• Study Completion (ANTICIPATED): June 30, 2021

Study Registration Dates

• First Submitted: June 26, 2019
• First Submitted That Met QC Criteria: June 26, 2019
• First Posted (ACTUAL): June 28, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 28, 2019
• Last Update Submitted That Met QC Criteria: June 26, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: UWestIndiesSt.Augustine

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