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RecruitingNCT06652230Updated Oct 22, 2024

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

An interventional study of Smile Arc Marginal Ridge Approach (SAMRA) and MBT Chart Method in Class I Malocclusion, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to participants aged 11 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-22.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 3 months ago, but the record still lists the study as recruiting.
  • Started Aug 2024; still recruiting 2 years 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
11 Years to 30 Years
Sex
All
01

Study 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.
02

Conditions studied

  • Class I Malocclusion
03

In context

Malocclusion, Angle Class I

35 studies on the registry are indexed under Malocclusion, Angle Class I; 10 are open to participants now.

This study's planned enrollment of 30 is close to the median of 32 across 31 interventional studies indexed under Malocclusion, Angle Class I.

Browse Malocclusion, Angle Class I studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
11 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Smile Arc Marginal Ridge Approach (SAMRA)

    Other: Smile Arc Marginal Ridge Approach (SAMRA)

  • Active comparator
    MBT Chart Method

    Other: MBT Chart Method

Interventions

  • OtherSmile Arc Marginal Ridge Approach (SAMRA)

    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.

  • OtherMBT Chart Method

    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.

06

What researchers measure

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.

    Time frame: 6 months

Secondary outcomes

  1. Number of additional archwire bending and bracket repositioning needed

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2024 (actual). Primary completion is estimated for Aug 2025, 12 months after the start.

Of 23 interventional studies with no phase under Malocclusion, Angle Class I, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 24. This study's planned 12 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 11, 2024
First posted
Oct 22, 2024
StartActual
Aug 1, 2024
Primary completionEst.
Aug 2025
CompletionEst.
Aug 2025
Last update
Oct 22, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06652230
Lead sponsor
Cairo University
Responsible party
Medhat Mostafa Kamal Abdelaziz (Principal Investigator, Cairo University) — Principal investigator
First posted
Oct 22, 2024
Start date
Aug 1, 2024
Primary completion
Aug 2025 (estimated)
Completion
Aug 2025 (estimated)
Last update
Oct 22, 2024

Study contacts

Medhat Mostafa Kamal
Contact
Medhat-Mostafa@dentistry.cu.edu.eg
+201229235977

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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