Class I MalocclusionNCT06652230
Assessment of Treatment Efficacy Using Smile Arc Marginal Ridge Approach Versus MBT Chart Method for Bracket Positioning
A study testing Smile Arc Marginal Ridge Approach (SAMRA) and MBT Chart Method in people with Class I Malocclusion, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Class I Malocclusion
- What is being tested?
- Smile Arc Marginal Ridge Approach (SAMRA) and MBT Chart Method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2024to Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry Cairo University
Cairo, Manial, 12613
Medhat M Kamal, +201229235977, Medhat-Mostafa@dentistry.cu.edu.eg
About this study
Official title: Assessment of Treatment Efficacy Using Smile Arc Marginal Ridge Approach Versus MBT Chart Method for Bracket Positioning: A Randomized Clinical Trial
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:
Read more
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
- Being tested
- Smile Arc Marginal Ridge Approach (SAMRA), MBT Chart Method
- Medical subject headings
- Malocclusion, Angle Class I
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 MethodOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Smile Arc Marginal Ridge Approach (SAMRA) | Experimental | Not described Receives: Other: Smile Arc Marginal Ridge Approach (SAMRA) |
| MBT Chart Method | Active comparator | Not described Receives: Other: MBT Chart Method |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
Number of additional archwire bending and bracket repositioning needed
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start1 Aug 2024
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class I MalocclusionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Medhat Mostafa Kamal Abdelaziz, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06652230
- Sponsor's protocol ID
- 42/7/24
- Status last verified
- Oct 2024
- First submitted
- 11 Oct 2024
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Treatment Efficacy Using Smile Arc Marginal Ridge Approach Versus MBT Chart Method for Bracket Positioning: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06652230
- Acronym / sponsor ID
- 42/7/24
- Conditions
- Class I Malocclusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 22 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smile Arc Marginal Ridge Approach (SAMRA) | Experimental | Other: Smile Arc Marginal Ridge Approach (SAMRA) |
| MBT Chart Method | Active comparator | Other: MBT Chart Method |
Who may qualify
- Ages
- 11 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smile 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. | Other | Smile Arc Marginal Ridge Approach (SAMRA) |
| MBT Chart MethodFor 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. | Other | MBT Chart Method |
Primary outcome
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.
1 secondary outcome
Number of additional archwire bending and bracket repositioning needed
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smile Arc Marginal Ridge Approach (SAMRA) and MBT Chart Method in people with Class I Malocclusion, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Medhat Mostafa Kamal (+201229235977, Medhat-Mostafa@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Orthodontic treatment results (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2024.