The Decrowding Rate Post Premolar Extraction With and Without Fixed Appliance: Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Anterior teeth alignment every 4 weeks at each time point.
Study Overview
Brief Summary
In orthodontics, the teeth tend to move to the extraction space. This tooth movement becomes of larger importance when there is a crowding. During the COVID lockdown period, It was noted that some cases have a significant improvement and almost all the crowding was relieved without appliance activation.
Detailed Description
In this randomized controlled trial, a sufficient number of patients would be randomly assigned into two groups; one with braces and one without fixed braces.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
The two groups will have lingual arches. However, patients without braces will not be informed about their braces before 5 months of trial initiation.
Eligibility Criteria
- Ages
- 13 Years to 30 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •- Patients with permanent dentition between age group of 13 - 30 years.
- •Maxillary or mandibular crowding >4.1mm and requiring extraction of maxillary first premolars or mandibular first premolars. The crowding will be measured using a caliper one cast models.
- •Fully erupted teeth from 1st molar to the 1st molar.
- •Patients with periodontally sound dentition.
- •Patients with good general health. No previous history of extraction or orthodontic tooth movement.
Exclusion Criteria
- •Cases requiring orthognathic surgery.
- •History of systemic and medical illness.
- •Contraindication of extraction.
- •Previous history of orthodontic treatment.
- •Poor oral hygiene.
- •Nickel allergy.
Outcomes
Primary Outcomes
Anterior teeth alignment every 4 weeks at each time point.
Time Frame: 6 months
The cumulative before extraction and space closure for 4 months (mean difference before and after)..
Secondary Outcomes
- Gingival invagination(9 months)
- Molar anchorage loss at each time point.(6 months)
Investigators
Samer Mheissen
Researcher
Samer Mheissen