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

Study Overview
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Brief Summary
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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

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

Conditions
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Bimaxillary Proclination

Intervention / Treatment
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* Other: Orthodontic Brackets


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Orthodontic Brackets|Self ligating and Conventional brackets|

What is the study measuring?
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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 |