Assessment of Treatment Efficacy Using Smile Arc Marginal Ridge Approach Versus MBT Chart Method for Bracket Positioning

NCT06652230 | Recruiting DMC FDA Device

• 1 other identifier: 42/7/24
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Class I Malocclusion

Outcome Measures

Primary Outcomes (1)

• Orthodontic treatment results

  Orthodontic treatment results will be assessed according to the American Board of Orthodontics Objective Grading System (ABO-OGS) using the ABO measuring gauge.

  6 months

Secondary Outcomes (1)

• Number of additional archwire bending and bracket repositioning needed

  6 months

Study Arms (2)

Smile Arc Marginal Ridge Approach (SAMRA)

EXPERIMENTAL

Other: Smile Arc Marginal Ridge Approach (SAMRA)

MBT Chart Method

ACTIVE COMPARATOR

Other: MBT Chart Method

Interventions

Smile Arc Marginal Ridge Approach (SAMRA) OTHER

Smile Arc Marginal Ridge Approach (SAMRA) is a new orthodontic bonding technique proposed by Dr. Dalia El Bokle where she stated that it provides more accurate orthodontic results and less time and effort needed during finished. No randomized clinical trials are done on this new approach yet so our study is the first one to test it. 0.018-inch MBT brackets will be used in our study.

Smile Arc Marginal Ridge Approach (SAMRA)

MBT Chart Method OTHER

For our comparator group MBT Chart Method will be used. Using charts during orthodontic bonding procedures is considered the gold standard. 0.018-inch brackets will be used.

MBT Chart Method

Eligibility Criteria

• Age: 11 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry Cairo University

Cairo, Manial, 12613, Egypt

RECRUITING

MeSH Terms

Conditions

Malocclusion, Angle Class I

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Central Study Contacts

Medhat Mostafa Kamal

CONTACT

+201229235977; Medhat-Mostafa@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 22, 2024
• Study Start: August 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: October 22, 2024

Record last verified: 2024-10

Locations

EG (1)