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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04001816
Enrollment
100
Registered
2019-06-28
Start date
2017-01-04
Completion date
2021-06-30
Last updated
2019-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bimaxillary Proclination

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

Interventions

Self ligating and Conventional brackets

Sponsors

University of Dundee
CollaboratorOTHER
The University of The West Indies
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
11 Years to 16 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Treatment time18-24 monthsLength of time each bracket takes to treat a bimaxillary proclination patient

Countries

Trinidad and Tobago

Contacts

Primary ContactTrudee Hoyte
Trudee.Hoyte@sta.uwi.edu8686845008
Backup ContactDavid Bearn
D.Bearn@dundee.ac.uk+441382381604

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026