Malocclusion, Angle Class INCT07708363
Bracket Positioning Techniques and Quality of Orthodontic Finishing
A study testing Smile Arc Protection (SAP) bracket positioning, Smile Arc and Marginal Ridge Approach (SAMRA) bracket positioning; Procedure and McLaughlin-Bennett-Trevisi (MBT) chart bracket positioning in people with Malocclusion, Angle Class I and Dental Crowding, run by Future University in Egypt at 1 site in Egypt.
Trial summary
This three-arm randomized clinical trial compares three orthodontic bracket positioning techniques - Smile Arc Protection (SAP), Smile Arc and Marginal Ridge Approach (SAMRA), and the McLaughlin-Bennett-Trevisi (MBT) bracket placement chart (control) - in young patients with Angle Class I malocclusion and… Read more about this study
- Who is it for?
- Ages 14 to 25 years
- Conditions the study is for
- Malocclusion, Angle Class I, Dental Crowding
- What is being tested?
- Smile Arc Protection (SAP) bracket positioning, Smile Arc and Marginal Ridge Approach (SAMRA) bracket positioning; Procedure and McLaughlin-Bennett-Trevisi (MBT) chart bracket positioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2024to 1 Jul 2026
- 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 14 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Males and females aged 14-25 years with a full permanent dentition.
- Mild to moderate crowding requiring non-extraction orthodontic treatment (2-6 mm per Graber's classification).
- Angle Class I malocclusion.
- Normal skeletal vertical dimension (SN-MP angle 32° ± 5°).
Who cannot join
- 1. Medication that may cause gingival inflammation (e.g., cyclosporine, phenytoin).
- 2. Impacted, extracted, or missing permanent teeth (except third molars). 3. Periodontal disease or parafunctional habits (bruxism, tongue thrusting, mouth breathing).
- 4. History of previous orthodontic treatment. 5. Craniofacial anomalies, facial asymmetry, or skeletal discrepancy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of Orthodontics, Faculty of Oral and Dental Medicine, Future University in Egypt, Cairo, Egypt
New Cairo, Cairo Governorate, 11835
About this study
Official title: Comparison of Three Bracket Positioning Techniques (Smile Arc Protection, Smile Arc and Marginal Ridge Approach, and McLaughlin-Bennett-Trevisi) on the Quality of Orthodontic Finishing, Mini-Esthetics, and Anterior Tooth Tip and Torque: A Three-Arm Randomized Clinical Trial
This three-arm randomized clinical trial compares three orthodontic bracket positioning techniques - Smile Arc Protection (SAP), Smile Arc and Marginal Ridge Approach (SAMRA), and the McLaughlin-Bennett-Trevisi (MBT) bracket placement chart (control) - in young patients with Angle Class I malocclusion and mild-to-moderate crowding treated non-extraction. The primary aim is to determine which technique yields the highest quality of orthodontic finishing, measured with the American Board of Orthodontics Objective Grading System (ABO-OGS). Secondary aims compare anterior tooth tip and torque (assessed by CBCT) and mini-esthetic smile parameters (gingival display, incisal display, buccal corridor, and smile arc, assessed on standardized posed-smile photographs) among the three techniques.
Read the detailed description
Bracket positioning is one of the most influential operator-dependent factors affecting the quality of orthodontic finishing and the resulting smile esthetics. Three contemporary positioning philosophies are compared in this trial.
Design. Eligible participants are randomly allocated 1:1:1 to one of three parallel arms. Allocation is generated with an online randomizer, concealed in sequentially opaque sealed envelopes held by a co-supervisor, and revealed only on the day of intervention. Outcome assessors are blinded; operator blinding is not feasible.
Intervention. All arms receive a fully digital indirect-bonding workflow (intraoral scanning, virtual bracket placement in 3Shape Ortho-Analyzer, 3D-printed casts, vacuum-formed transfer trays) using a 0.018-inch MBT prescription, and an identical arch wire sequence ending in a 0.017 in × 0.025 in stainless steel wire maintained for three months. The arms differ only in the vertical/angular bracket-positioning rule applied (SAP, SAMRA, or MBT chart).
Assessment. Records are captured before bonding (T₀) and at the end of levelling and alignment (T₁). The ABO-OGS is scored on 3D-printed casts and the panoramic radiograph; tip and torque are measured on dentoalveolar CBCT; mini-esthetic parameters are measured on standardized frontal posed-smile photographs calibrated in Adobe Photoshop.
- Conditions
- Malocclusion, Angle Class I, Dental Crowding
- Being tested
- Smile Arc Protection (SAP) bracket positioning, Smile Arc and Marginal Ridge Approach (SAMRA) bracket positioning; Procedure, McLaughlin-Bennett-Trevisi (MBT) chart bracket positioning
- Keywords
- Bracket positioning, Smile arc, Indirect bonding, ABO Objective Grading System, Mini-esthetics, Tip and torque, Orthodontic finishing
- Medical subject headings
- Malocclusion, Angle Class I, Crowding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smile Arc Protection (SAP) bracket positioningProcedure or surgery
Bracket positioning by the Smile Arc Protection technique (anterior brackets placed relatively more gingival, referenced to canine crown height).
Smile Arc and Marginal Ridge Approach (SAMRA) bracket positioning; ProcedureProcedure or surgery
Bracket positioning by the Smile Arc and Marginal Ridge Approach (digital workflow referencing the marginal-ridge line and facial axis).
McLaughlin-Bennett-Trevisi (MBT) chart bracket positioningProcedure or surgery
Bracket positioning by the McLaughlin-Bennett-Trevisi bracket placement chart (bracket-to-incisal-edge distances from the standardized chart).
| Study group | Role | What they receive |
|---|---|---|
| Group SAP | Experimental | Bracket positioning by the Smile Arc Protection technique (anterior brackets placed relatively more gingival, referenced to canine crown height). Receives: Procedure: Smile Arc Protection (SAP) bracket positioning |
| Group SAMRA | Experimental | Bracket positioning by the Smile Arc and Marginal Ridge Approach (digital workflow referencing the marginal-ridge line and facial axis). Receives: Procedure: Smile Arc and Marginal Ridge Approach (SAMRA) bracket positioning; Procedure |
| Group MBT (Control) | Active comparator | Bracket positioning by the McLaughlin-Bennett-Trevisi bracket placement chart (bracket-to-incisal-edge distances from the standardized chart). Receives: Procedure: McLaughlin-Bennett-Trevisi (MBT) chart bracket positioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of orthodontic finishing - ABO Objective Grading System (ABO-OGS) total score
Total ABO-OGS score obtained on the Cast-Radiographic Evaluation (CRE) form. Seven parameters - alignment/rotations, marginal ridges, buccolingual inclination, occlusal contacts, occlusal relationships, overjet, and interproximal contacts - are scored on 3D-printed casts with the ABO measuring gauge; root angulation is scored on the panoramic radiograph. Point deductions are summed to give the total score (a lower total indicates better finishing).
Measured: At completion of the levelling and alignment phase (T₁), after the 0.017 in × 0.025 in stainless steel arch wire has been maintained for 3 months - approximately 7 months after bonding.
Secondary outcomes (6)
Anterior crown angulation (tip) - CBCT
Change in mesiodistal crown angulation (tip) of the anterior teeth, measured in degrees on dentoalveolar CBCT using defined landmarks and reference planes.
Measured: Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
Anterior crown inclination (torque) - CBCT
Change in labiolingual crown inclination (torque) of the anterior teeth, measured in degrees on dentoalveolar CBCT.
Measured: Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
Maxillary gingival display
Change in maxillary gingival display - the vertical distance (mm) between the inferior border of the upper lip and the gingival zenith of each maxillary anterior tooth (central incisor, lateral incisor, canine, both sides) on standardized posed-smile frontal photographs, measured in Adobe Photoshop after calibration against a metric ruler.
Measured: Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
Maxillary incisal display
Change in maxillary incisal display - the vertical amount (mm) of maxillary incisor crown visible relative to the upper lip during a posed smile, on standardized photographs.
Measured: Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
Buccal corridor width
Change in buccal corridor (lateral negative space) - the linear distance (mm) between the most posterior visible maxillary tooth and the corner of the mouth during posed smile, measured on each side and averaged.
Measured: Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
Smile arc category
Smile arc classified as consonant, flat, or reversed based on the relationship between the curvature of the maxillary incisal/canine/premolar edges and the curvature of the lower lip during posed smile.
Measured: Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start1 Jul 2024
- Primary completion1 Jul 2026
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malocclusion, Angle Class IStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hager Mansour Abdelbaseer Zoghby, Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07708363
- Sponsor's protocol ID
- FUE.REC(42)/10-2024
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Study data are stored confidentially within the Department of Orthodontics with access restricted to the investigator and supervisors; results will be disseminated through the institutional thesis repository and peer-reviewed publication.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Three Bracket Positioning Techniques (Smile Arc Protection, Smile Arc and Marginal Ridge Approach, and McLaughlin-Bennett-Trevisi) on the Quality of Orthodontic Finishing, Mini-Esthetics, and Anterior Tooth Tip and Torque: A Three-Arm Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07708363
- Acronym / sponsor ID
- FUE.REC(42)/10-2024
- Conditions
- Malocclusion, Angle Class I, Dental Crowding
- Keywords
- Bracket positioning, Smile arc, Indirect bonding, ABO Objective Grading System, Mini-esthetics, Tip and torque, Orthodontic finishing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 16 Jul 2026 (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.
This three-arm randomized clinical trial compares three orthodontic bracket positioning techniques - Smile Arc Protection (SAP), Smile Arc and Marginal Ridge Approach (SAMRA), and the McLaughlin-Bennett-Trevisi (MBT) bracket placement chart (control) - in young patients with Angle Class I malocclusion and mild-to-moderate crowding treated non-extraction. The primary aim is to determine which technique yields the highest quality of orthodontic finishing, measured with the American Board of Orthodontics Objective Grading System (ABO-OGS). Secondary aims compare anterior tooth tip and torque (assessed by CBCT) and mini-esthetic smile parameters (gingival display, incisal display, buccal corridor, and smile arc, assessed on standardized posed-smile photographs) among the three techniques.
Detailed description
Bracket positioning is one of the most influential operator-dependent factors affecting the quality of orthodontic finishing and the resulting smile esthetics. Three contemporary positioning philosophies are compared in this trial.
Design. Eligible participants are randomly allocated 1:1:1 to one of three parallel arms. Allocation is generated with an online randomizer, concealed in sequentially opaque sealed envelopes held by a co-supervisor, and revealed only on the day of intervention. Outcome assessors are blinded; operator blinding is not feasible.
Intervention. All arms receive a fully digital indirect-bonding workflow (intraoral scanning, virtual bracket placement in 3Shape Ortho-Analyzer, 3D-printed casts, vacuum-formed transfer trays) using a 0.018-inch MBT prescription, and an identical arch wire sequence ending in a 0.017 in × 0.025 in stainless steel wire maintained for three months. The arms differ only in the vertical/angular bracket-positioning rule applied (SAP, SAMRA, or MBT chart).
Assessment. Records are captured before bonding (T₀) and at the end of levelling and alignment (T₁). The ABO-OGS is scored on 3D-printed casts and the panoramic radiograph; tip and torque are measured on dentoalveolar CBCT; mini-esthetic parameters are measured on standardized frontal posed-smile photographs calibrated in Adobe Photoshop.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group SAP | Experimental | Procedure: Smile Arc Protection (SAP) bracket positioningBracket positioning by the Smile Arc Protection technique (anterior brackets placed relatively more gingival, referenced to canine crown height). |
| Group SAMRA | Experimental | Procedure: Smile Arc and Marginal Ridge Approach (SAMRA) bracket positioning; ProcedureBracket positioning by the Smile Arc and Marginal Ridge Approach (digital workflow referencing the marginal-ridge line and facial axis). |
| Group MBT (Control) | Active comparator | Procedure: McLaughlin-Bennett-Trevisi (MBT) chart bracket positioningBracket positioning by the McLaughlin-Bennett-Trevisi bracket placement chart (bracket-to-incisal-edge distances from the standardized chart). |
Who may qualify
- Ages
- 14 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Males and females aged 14-25 years with a full permanent dentition.
- Mild to moderate crowding requiring non-extraction orthodontic treatment (2-6 mm per Graber's classification).
- Angle Class I malocclusion.
- Normal skeletal vertical dimension (SN-MP angle 32° ± 5°).
Key exclusion criteria (3 listed)
- 1. Medication that may cause gingival inflammation (e.g., cyclosporine, phenytoin).
- 2. Impacted, extracted, or missing permanent teeth (except third molars). 3. Periodontal disease or parafunctional habits (bruxism, tongue thrusting, mouth breathing).
- 4. History of previous orthodontic treatment. 5. Craniofacial anomalies, facial asymmetry, or skeletal discrepancy.
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 Protection (SAP) bracket positioningBracket positioning by the Smile Arc Protection technique (anterior brackets placed relatively more gingival, referenced to canine crown height). | Procedure or surgery | Group SAP |
| Smile Arc and Marginal Ridge Approach (SAMRA) bracket positioning; ProcedureBracket positioning by the Smile Arc and Marginal Ridge Approach (digital workflow referencing the marginal-ridge line and facial axis). | Procedure or surgery | Group SAMRA |
| McLaughlin-Bennett-Trevisi (MBT) chart bracket positioningBracket positioning by the McLaughlin-Bennett-Trevisi bracket placement chart (bracket-to-incisal-edge distances from the standardized chart). | Procedure or surgery | Group MBT (Control) |
Primary outcome
Quality of orthodontic finishing - ABO Objective Grading System (ABO-OGS) total score
Time frame: At completion of the levelling and alignment phase (T₁), after the 0.017 in × 0.025 in stainless steel arch wire has been maintained for 3 months - approximately 7 months after bonding.
Total ABO-OGS score obtained on the Cast-Radiographic Evaluation (CRE) form. Seven parameters - alignment/rotations, marginal ridges, buccolingual inclination, occlusal contacts, occlusal relationships, overjet, and interproximal contacts - are scored on 3D-printed casts with the ABO measuring gauge; root angulation is scored on the panoramic radiograph. Point deductions are summed to give the total score (a lower total indicates better finishing).
6 secondary outcomes
Anterior crown angulation (tip) - CBCT
Time frame: Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
Anterior crown inclination (torque) - CBCT
Time frame: Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
Maxillary gingival display
Time frame: Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
Maxillary incisal display
Time frame: Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
Buccal corridor width
Time frame: Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
Smile arc category
Time frame: Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: Undecided. Study data are stored confidentially within the Department of Orthodontics with access restricted to the investigator and supervisors; results will be disseminated through the institutional thesis repository and peer-reviewed publication.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Protection (SAP) bracket positioning, Smile Arc and Marginal Ridge Approach (SAMRA) bracket positioning; Procedure and McLaughlin-Bennett-Trevisi (MBT) chart bracket positioning in people with Malocclusion, Angle Class I and Dental Crowding, run by Future University in Egypt 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 16 Jul 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of orthodontic finishing - ABO Objective Grading System (ABO-OGS) total score (time frame: At completion of the levelling and alignment phase (T₁), after the 0.017 in × 0.025 in stainless steel arch wire has been maintained for 3 months - approximately 7 months after bonding.). 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 16 Jul 2026.