Comparative evaluation of rate of extraction space closure between early and delayed therapeutic 1st premolar extraction in bimaxillary protrusion patients using mini implants. A Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Rate of extraction space closure in early and delayed extraction of 1st premolars
Study Overview
Brief Summary
This study is a randomized, parallel group trial investigating in Bimaxillary protrusion patients the effect of early versus delayed extraction (premolar) on the speed of tooth movement in orthodontic treatment by using mini implants. The primary outcome of the study is to compare and evaluate the rate of extraction space closure in early and delayed extraction of 1st premolars for the period of 20 months. The secondary outcomes is to assess root resorption of maxillary anterior teeth pre-treatment and post-retraction and also to assess Tooth angulation of maxillary incisor teeth pre-treatment and post-retraction for the period of 20 months. Total sample size was calculated to be 30 including expected dropout rate of 20 %.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 35.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Class 1 bi-maxillary protrusion without any impacted teeth in maxillary and mandibular anterior region.
- •2.Cases requiring extraction of both maxillary and mandibular first premolar 3.Little’s index for crowding: 1- 3 mm (minimal crowding) 4.Adult patients 18-35 years of age, both male and female.
- •5.Patients with periodontally sound dentition.
- •6.Patients with good general health.
Exclusion Criteria
- •1.Skeletal/Dental class II malocclusion 2.Skeletal/Dental class III malocclusion 3.Poor oral hygiene 4.Smoking.
Outcomes
Primary Outcomes
Rate of extraction space closure in early and delayed extraction of 1st premolars
Time Frame: 20 months
Secondary Outcomes
- To assess Root resorption of maxillary anterior teeth pre-treatment and post-retraction(20 months)
- To assess Tooth angulation of maxillary incisor teeth pre-treatment and post-retraction(20 months)
Investigators
Dr Mohamed Shamsudeen
Government Dental College and Hospital, Cuddalore