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Clinical Trials/NCT06652230
NCT06652230RecruitingNot Applicable

Assessment of Treatment Efficacy Using Smile Arc Marginal Ridge Approach Versus MBT Chart Method for Bracket Positioning: A Randomized Clinical Trial

Cairo University2 sites in 1 country30 target enrollmentStarted: August 1, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Medhat Mostafa Kamal Abdelaziz

Principal Investigator

Cairo University

Study Sites (2)

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