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Completed

NCT Number: NCT07503314

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

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

Completed

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Key information

Age range

13 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marium Jamil

Lahore, Punjab Province, 2500, Pakistan

About this study

This prospective, randomized controlled trial was conducted to evaluate the clinical effects of self-ligating brackets (SLBs) versus conventional brackets (CBs) in patients requiring premolar extractions. The study included 70 participants aged 13-30 years with moderate to severe crowding and skeletal Class I or mild-to-moderate Class II malocclusions.

Participants were randomly assigned to either the SLB or CB group (35 participants each) using computer-generated random numbers and allocation concealment through sequentially numbered, opaque, sealed envelopes. Blinding of the operator and participants was not possible due to the nature of the interventions; however, outcome assessors were blinded by covering brackets on dental casts with beading wax.

The study assessed alignment efficiency, arch dimensional changes, and passive extraction space closure over a 9-month period. Dental impressions and study casts were collected at baseline, 3, 6, and 9 months. Alignment was quantified using Little's Irregularity Index, while intercanine and intermolar widths and passive extraction space closure were measured using digital calipers. No active space-closing auxiliaries, such as power chains or springs, were used during the observation period.

All treatments were performed by trained orthodontic residents with calibration to ensure consistency in bonding procedures, archwire sequence, and ligation methods. Linear mixed-effects models with repeated measures and covariates (age, gender, and malocclusion type) were used for statistical analysis, and regression coefficients with 95% confidence intervals were reported.

The trial aims to determine whether SLBs differ from conventional brackets in terms of alignment speed, arch dimensional changes, and passive space closure in extraction cases. Findings from this study can inform evidence-based bracket selection and clinical decision-making in orthodontic practice.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age 13-30 years, any gender Moderate (4-8 mm) or severe (>8 mm) dental crowding Skeletal Class I (ANB 0-20) or mild-to-moderate Class II (ANB 3-50) Normal or vertical growth pattern (FMA 22-280) Good oral hygiene (plaque index ≤1) Require extraction-based orthodontic treatment

Exclusion criteria

Previous orthodontic treatment Asymmetric extractions Systemic diseases or medications affecting bone metabolism Cleft lip/palate or other craniofacial anomalies Congenital absence of teeth (except third molars) Low-angle (hypodivergent) growth pattern Inability to comply with treatment/follow-up

Treatment and study plan

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

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.

Primary outcomes

  1. Dental alignment assessed by Little's Irregularity Index

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

    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.

  2. Intermolar width

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

    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.

Secondary outcomes

  1. Intercanine width

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

    Distance between the cusp tips of the canines on study casts. Measured by a blinded examiner using a digital caliper (0.01 mm accuracy) to monitor transverse changes in the anterior arch.

  2. Passive extraction space closure

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

    Measured at extraction sites as the distance between nearest reproducible points on crowns adjacent to extraction sites. No active space-closing auxiliaries were used to isolate the effect of bracket type. Measured by a blinded examiner using digital calipers.

Sponsors and collaborators

Lead sponsor

Saidu College of Dentistry

Other

Registry information

Official study title

Comparison of Alignment Efficiency, Arch Dimensional Changes, and Passive Extraction Space Closure Between Self-Ligating and Conventional Brackets: A Prospective Randomized Clinical Trial

Acronym: SLBs CBs RCT

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 31, 2026
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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