Assessment of Treatment Efficacy Using Smile Arc Marginal Ridge Approach Versus MBT Chart Method for Bracket Positioning: A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Cairo University
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Orthodontic treatment results
Study Overview
Brief Summary
The goal of this randomized clinical trial is to evaluate the effect of Smile Arc Marginal Ridge Approach (SAMRA) versus MBT chart method for bracket positioning on orthodontic treatment results.
The main questions it aims to answer are:
Is there a difference in orthodontic treatment results between smile arc marginal ridge approach (SAMRA) and MBT chart method for bracket positioning?
Does SAMRA provide more accurate orthodontic results and reduce the number of archwire bendings and brackets repositioning needed during finishing?
The investigators will compare Smile Arc Marginal Ridge Approach (SAMRA) with MBT Chart Method (gold standard) to see if SAMRA provides more accurate orthodontic results and reduce the need for archwire bendings and brackets repositioning during finishing.
Participants will:
- Undergo orthodontic treatment and divided into two groups, Group A (SAMRA) and Group B (MBT Chart Method).
- 0.018-inch MBT brackets will be used in both groups.
- Follow ups every 1 month will take place to change the archwires after becoming passive.
- After leveling and alignment is completed, orthodontic treatment results, number of archwire bendings and brackets repositioning needed will be determined to see which type of intervention is better or if both provide similar results.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 11 Years to 30 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Orthodontic patients aged 11-30 years old.
- •Mild or moderate crowding not requiring tooth extraction.
- •Full permanent dentition including fully erupted 7s not necessarily 8s.
- •Good oral hygiene.
- •Skeletal and dentoalveolar class I malocclusion.
Exclusion Criteria
- •Systemic disease potentially affecting the study outcome.
- •Cleft lip and palate/syndromic patients.
- •Any signs or symptoms of temporomandibular disorders (TMD).
- •Previous orthodontic treatment.
- •Pregnant females.
- •Chronic use of medications.
Outcomes
Primary Outcomes
Orthodontic treatment results
Time Frame: 6 months
Orthodontic treatment results will be assessed according to the American Board of Orthodontics Objective Grading System (ABO-OGS) using the ABO measuring gauge.
Secondary Outcomes
- Number of additional archwire bending and bracket repositioning needed(6 months)
Investigators
Medhat Mostafa Kamal Abdelaziz
Principal Investigator
Cairo University
