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

Not Applicable

• Conditions: Bimaxillary Proclination

• Registration Number: NCT04001816
• Lead Sponsor: The University of The West Indies

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-04
• Status Verified: 2019-06
• Study First Submitted: 2019-06-26
• Study First Submitted QC: 2019-06-26
• Last Update Submitted: 2019-06-26
• Study First Posted: 2019-06-28
• Last Update Posted: 2019-06-28
• Primary Completion: 2021-05-31
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Treatment time	18-24 months	Length of time each bracket takes to treat a bimaxillary proclination patient

Trial Locations

Locations (1)

UWI Dental School; 🇹🇹 Saint Augustine, Trinidad and Tobago