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NCT Number: NCT06652230

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

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.

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Key information

Conditions

Class I Malocclusion Malocclusion Malocclusion, Angle Class I Stomatognathic Diseases Tooth Diseases

Age range

11 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry Cairo University

Cairo, Manial, 12613, Egypt

Location status: Recruiting

Location contact

Medhat M Kamal

CONTACT

[email protected]

+201229235977

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

  1. Number of additional archwire bending and bracket repositioning needed

    Time frame: 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Medhat Mostafa Kamal

CONTACT

[email protected]

+201229235977

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 22, 2024
Registry last updated
Oct 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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