Comparison of Alignment Efficiency, Arch Dimensional Changes, and Passive Extraction Space Closure Between Self-Ligating and Conventional Brackets

NCT07503314 | Completed DMC

• 1 other identifier: UHS-ORTHO-2026-01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: This study aims to compare two types of orthodontic braces - self-ligating brackets (SLBs) and conventional brackets (CBs) - to see which one aligns teeth faster, affects the width of the dental arch, and closes spaces after premolar extractions more efficiently. Who Can Join: Ages 13-30 years Moderate to severe dental crowding Skeletal Class I or mild to moderate Class II malocclusions Good oral hygiene Requiring extraction of premolars What Participants Will Do: Participants are randomly assigned to either the SLB group or the CB group. Braces are bonded to the teeth following standard orthodontic procedures. Dental impressions and measurements will be taken at baseline, 3, 6, and 9 months. No extra devices (like power chains) will be used for space closure during the study. What is Being Measured: Alignment of teeth using Little's Irregularity Index Intercanine and intermolar widths (arch dimensions) Passive closure of extraction spaces Why This Study is Being Done: The study investigates whether SLBs provide any clinical advantage over conventional braces in terms of faster alignment, arch width changes, and efficient space closure in extraction cases. This could help orthodontists make evidence-based decisions when choosing braces. Study Duration: Total observation period: 9 months Monthly follow-ups for adjustments and measurements

Conditions

Dental Crowding; Passive Extraction Space; Intercanine Width; Intermolar Width

Keywords

Self-ligating brackets; Conventional brackets; Orthodontic alignment; Dental crowding

Outcome Measures

Primary Outcomes (2)

• Dental alignment assessed by Little's Irregularity Index

  The primary outcome is the degree of dental alignment in extraction cases, measured on study casts using Little's Irregularity Index. Measurements were performed by a single calibrated examiner blinded to bracket type using a digital caliper (0.01 mm accuracy). Higher scores indicate greater crowding, while lower scores indicate improved alignment.

  Baseline (T₀) to 9 months (T₃), assessed at 3-month intervals

• Intermolar width

  The primary outcome is the degree of dental alignment in extraction cases, measured on study casts using Little's Irregularity Index. Measurements were performed by a single calibrated examiner blinded to bracket type using a digital caliper (0.01 mm accuracy). Higher scores indicate greater crowding, while lower scores indicate improved alignment.

  Baseline (T₀) to 9 months (T₃), assessed at 3-month intervals

Secondary Outcomes (2)

• Intercanine width

  Baseline (T₀) to 9 months (T₃), assessed at 3-month intervals

• Passive extraction space closure

  Baseline (T₀) to 9 months (T₃), assessed at 3-month intervals

Study Arms (2)

Conventional Bracket Group (CB)

ACTIVE COMPARATOR

Participants in this group received 0.022-inch slot conventional MBT brackets (Dentaurum, Germany) bonded to all teeth up to the second premolars. Alignment started with 0.014-inch NiTi archwires and progressed according to a standardized archwire sequence. Stainless steel lacebacks were used for early canine control, and no active space-closing auxiliaries (e.g., power chains or closed-coil springs) were applied during the 9-month observation period. Outcome measurements were taken at baseline, 3, 6, and 9 months on blinded study casts.

Device: Self-Ligating Brackets (SLB)

Self-Ligating Bracket Group (SLB)

EXPERIMENTAL

Participants in this group received 0.022-inch slot self-ligating MBT brackets (American Orthodontics, USA) bonded to all teeth up to the second premolars. Alignment started with 0.014-inch NiTi archwires and progressed using the same standardized archwire sequence. Stainless steel lacebacks were applied for early canine control, and no active space-closing auxiliaries were used during the 9-month observation period. Outcome measurements were taken at baseline, 3, 6, and 9 months on blinded study casts.

Device: Conventional Bracket

Interventions

Self-Ligating Brackets (SLB) DEVICE

Participants received 0.022-inch slot MBT conventional brackets (Equilibrium 2, Dentaurum, Germany) bonded to all teeth up to the second premolars. Alignment began with 0.014-inch NiTi archwires and progressed through the same standardized sequence as the SLB group. Stainless steel lacebacks were applied for early canine control. No active space-closing auxiliaries (power chains or closed-coil springs) were used during the 9-month observation period. Outcome measurements were taken at baseline, 3, 6, and 9 months on blinded study casts.

Conventional Bracket Group (CB)

Conventional Bracket DEVICE

Participants in this arm received 0.022-inch slot MBT conventional brackets (Equilibrium 2, Dentaurum, Germany) bonded to all teeth up to the second premolars. Alignment began with 0.014-inch NiTi archwires and progressed using a standardized archwire sequence (0.016, 0.018 NiTi, 0.016×0.022 NiTi, 0.019×0.025 stainless steel). Stainless steel lacebacks were applied for early canine control, and no active space-closing auxiliaries (e.g., power chains or NiTi closed-coil springs) were used during the 9-month observation period. Outcome measurements were taken at baseline, 3, 6, and 9 months on blinded study casts.

Self-Ligating Bracket Group (SLB)

Eligibility Criteria

• Age: 13 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

Sponsors & Collaborators

• Saidu College of Dentistry: lead

Study Sites (1)

Marium Jamil

Lahore, Punjab Province, 2500, Pakistan

Location

Related Publications (1)

• 14. Scott P, DiBiase AT, Sherriff M, Cobourne MT. Alignment efficiency of Damon3 self-ligating and conventional orthodontic bracket systems: a randomized clinical trial. American journal of orthodontics and dentofacial orthopedics. 2008;134(4):470. e1-. e8. 2. Fleming PS, DiBiase AT, Sarri G, Lee RT. Comparison of mandibular arch changes during alignment and leveling with 2 preadjusted edgewise appliances. American Journal of Orthodontics and Dentofacial Orthopedics. 2009;136(3):340-7. 3. Pandis N, Polychronopoulou A, Katsaros C, Eliades T. Comparative assessment of conventional and self-ligating appliances on the effect of mandibular intermolar distance in adolescent nonextraction patients: a single-center randomized controlled trial. American journal of orthodontics and dentofacial orthopedics. 2011;140(3):e99-e105.

  RESULT

MeSH Terms

Conditions

Crowding

Condition Hierarchy (Ancestors)

Spatial Behavior; Behavior

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: The University of Lahore, Pakistan

Model Details: This is a parallel-arm, randomized controlled trial comparing two types of fixed orthodontic appliances. Participants were randomly assigned to either the self-ligating bracket (SLB) group or the conventional bracket (CB) group in a 1:1 ratio. Each group received standard orthodontic treatment with premolar extractions, following the same archwire sequence and bonding protocols. Outcome measurements were taken at baseline, 3, 6, and 9 months.

Study Record Dates

• First Submitted: March 25, 2026
• First Posted: March 31, 2026
• Study Start: February 1, 2024
• Primary Completion: June 25, 2025
• Study Completion: June 25, 2025
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE
• Time Frame: IPD and supporting information will be available from 6 months after publication of the trial results and remain accessible for 5 years.
• Access Criteria: Qualified researchers can access the data for scientific purposes upon request. Requests require a brief proposal and agreement to data use terms to protect participant confidentiality. Data will be shared via secure email or repository upon request.

Locations

PA (1)