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

Bimaxillary Proclination Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04001816
• Other study ID #: UWestIndiesSt.Augustine
• Status: Recruiting
• Phase: N/A
• Start date: January 4, 2017
• Est. completion date: June 30, 2021

Study information

• Verified date: June 2019
• Source: The University of The West Indies
• Contact: Trudee Hoyte
• Phone: 8686845008
• Email: Trudee.Hoyte[@]sta.uwi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Bimaxillary Proclination

Intervention

Other:
• Orthodontic Brackets
Self ligating and Conventional brackets

Locations

Country	Name	City	State
Trinidad and Tobago	UWI Dental School	Saint Augustine

Sponsors (2)

Lead Sponsor	Collaborator
The University of The West Indies	University of Dundee

Country where clinical trial is conducted

Trinidad and Tobago, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment time	Length of time each bracket takes to treat a bimaxillary proclination patient	18-24 months