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

NCT04001816 | Unknown

• 1 other identifier: UWestIndiesSt.Augustine
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bimaxillary Proclination

Outcome Measures

Primary Outcomes (1)

• Treatment time

  Length of time each bracket takes to treat a bimaxillary proclination patient

  18-24 months

Interventions

Orthodontic Brackets OTHER

Self ligating and Conventional brackets

Eligibility Criteria

• Age: 11 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• The University of The West Indies: lead
• University of Dundee: collaborator

Study Sites (1)

UWI Dental School

Saint Augustine, Trinidad and Tobago

RECRUITING

MeSH Terms

Interventions

Orthodontic Brackets

Intervention Hierarchy (Ancestors)

Orthodontic Appliances, Fixed; Orthodontic Appliances; Orthodontics; Dentistry

Study Officials

• Trudee Hoyte

  The University of The West Indies

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Trudee Hoyte

CONTACT

8686845008; Trudee.Hoyte@sta.uwi.edu

David Bearn

CONTACT

+441382381604; D.Bearn@dundee.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 26, 2019
• First Posted: June 28, 2019
• Study Start: January 4, 2017
• Primary Completion: May 31, 2021
• Study Completion: June 30, 2021
• Last Updated: June 28, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

TR (1)