NCT07708363

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 7, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 16, 2026

Completed
Last Updated

July 16, 2026

Status Verified

July 1, 2026

Enrollment Period

2 years

First QC Date

July 7, 2026

Last Update Submit

July 10, 2026

Conditions

Keywords

Bracket positioningSmile arcIndirect bondingABO Objective Grading SystemMini-estheticsTip and torqueOrthodontic finishing

Outcome Measures

Primary Outcomes (1)

  • 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).

    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 from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding

  • Anterior crown inclination (torque) - CBCT

    Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding

  • Maxillary gingival display

    Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding

  • Maxillary incisal display

    Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding

  • Buccal corridor width

    Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding

  • +1 more secondary outcomes

Study Arms (3)

Group SAP

EXPERIMENTAL

Bracket positioning by the Smile Arc Protection technique (anterior brackets placed relatively more gingival, referenced to canine crown height).

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).

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).

Procedure: McLaughlin-Bennett-Trevisi (MBT) chart bracket positioning

Interventions

Bracket positioning by the Smile Arc Protection technique (anterior brackets placed relatively more gingival, referenced to canine crown height).

Group SAP

Bracket positioning by the Smile Arc and Marginal Ridge Approach (digital workflow referencing the marginal-ridge line and facial axis).

Group SAMRA

Bracket positioning by the McLaughlin-Bennett-Trevisi bracket placement chart (bracket-to-incisal-edge distances from the standardized chart).

Group MBT (Control)

Eligibility Criteria

Age14 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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°).

You may not qualify if:

  • \. Medication that may cause gingival inflammation (e.g., cyclosporine, phenytoin).
  • \. Impacted, extracted, or missing permanent teeth (except third molars). 3. Periodontal disease or parafunctional habits (bruxism, tongue thrusting, mouth breathing).
  • \. History of previous orthodontic treatment. 5. Craniofacial anomalies, facial asymmetry, or skeletal discrepancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthodontics, Faculty of Oral and Dental Medicine, Future University in Egypt, Cairo, Egypt

New Cairo, Cairo Governorate, 11835, Egypt

Location

MeSH Terms

Conditions

Malocclusion, Angle Class ICrowding

Condition Hierarchy (Ancestors)

MalocclusionTooth DiseasesStomatognathic DiseasesSpatial BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

July 7, 2026

First Posted

July 16, 2026

Study Start

July 1, 2024

Primary Completion

July 1, 2026

Study Completion

July 1, 2026

Last Updated

July 16, 2026

Record last verified: 2026-07

Locations