Dental CrowdingSLBs CBs RCTNCT07503314
Comparison of Alignment Efficiency, Arch Dimensional Changes, and Passive Extraction Space Closure Between Self-Ligating and Conventional Brackets
A study testing Self-Ligating Brackets (SLB) and Conventional Bracket in people with Dental Crowding and Passive Extraction Space, run by Saidu College of Dentistry at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Crowding, Passive Extraction Space, Intercanine Width
- What is being tested?
- Self-Ligating Brackets (SLB) and Conventional Bracket
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2024to 25 Jun 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 13 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Alignment Efficiency, Arch Dimensional Changes, and Passive Extraction Space Closure Between Self-Ligating and Conventional Brackets: A Prospective Randomized Clinical Trial
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.
Read more
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
Read the detailed description
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.
- Being tested
- Self-Ligating Brackets (SLB), Conventional Bracket
- Keywords
- Self-ligating brackets, Conventional brackets, Orthodontic alignment, Dental crowding
- Medical subject headings
- Crowding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 BracketDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Conventional Bracket |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (T₀) to 9 months (T₃), assessed at 3-month intervals
Secondary outcomes (2)
Intercanine width
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.
Measured: Baseline (T₀) to 9 months (T₃), assessed at 3-month intervals
Passive extraction space closure
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.
Measured: Baseline (T₀) to 9 months (T₃), assessed at 3-month intervals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start1 Feb 2024
- Primary completion25 Jun 2025
- Study completion25 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dental CrowdingStudies 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
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saidu College of Dentistry
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Ajmal Khan, Saidu College of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07503314
- Sponsor's protocol ID
- UHS-ORTHO-2026-01
- Other IDs
- UHS-ORTHO-2026-01
- Acronym
- SLBs CBs RCT
- Status last verified
- Mar 2026
- First submitted
- 25 Mar 2026
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) will include de-identified demographic, clinical, and outcome measurements (Little's Irregularity Index, intercanine and intermolar widths, arch depth, passive extraction space) collected during the trial. No personal identifiers will be included. Supporting documents such as study protocol, statistical analysis plan, and analytic code will also be shared.
Publications
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.
Jamil M, Bokhari F, Hammad A, Saeed H, Mumtaz M, Kamran MA, Alqerban A, Hussain U, Bukhary F, Rehman A. Comparison of Alignment Efficiency, Arch Dimensional Changes, and Passive Extraction Space Closure Between Self-Ligating and Conventional Brackets in Extraction Crowding Patients: A Prospective Randomized Clinical Trial. Int J Dent. 2026 Aug 13;2026:4061065. doi: 10.1155/ijod/4061065. eCollection 2026.
PubMed 42602182
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Alignment Efficiency, Arch Dimensional Changes, and Passive Extraction Space Closure Between Self-Ligating and Conventional Brackets: A Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07503314
- Acronym / sponsor ID
- SLBs CBs RCT / UHS-ORTHO-2026-01
- Keywords
- Self-ligating brackets, Conventional brackets, Orthodontic alignment, Dental crowding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Saidu College of DentistryUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 25 Jun 2025 (actual)
- Study completion
- 25 Jun 2025 (actual)
- First posted
- 31 Mar 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.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Conventional Bracket Group (CB) | Active comparator | Device: Self-Ligating Brackets (SLB)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. |
| Self-Ligating Bracket Group (SLB) | Experimental | Device: Conventional BracketParticipants 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. |
Who may qualify
- Ages
- 13 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| Self-Ligating Brackets (SLB)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. | Device | Conventional Bracket Group (CB) |
| Conventional BracketParticipants 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. | Device | Self-Ligating Bracket Group (SLB) |
Primary outcome
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.
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.
2 secondary outcomes
Intercanine width
Time frame: Baseline (T₀) to 9 months (T₃), assessed at 3-month intervals
Passive extraction space closure
Time frame: Baseline (T₀) to 9 months (T₃), assessed at 3-month intervals
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 31 Mar 2026.
- Results publication14. 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.
- Derived from this study: PubMed 42602182Jamil M, Bokhari F, Hammad A, Saeed H, Mumtaz M, Kamran MA, Alqerban A, Hussain U, Bukhary F, Rehman A. Comparison of Alignment Efficiency, Arch Dimensional Changes, and Passive Extraction Space Closure Between Self-Ligating and Conventional Brackets in Extraction Crowding Patients: A Prospective Randomized Clinical Trial. Int J Dent. 2026 Aug 13;2026:4061065. doi: 10.1155/ijod/4061065. eCollection 2026.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) will include de-identified demographic, clinical, and outcome measurements (Little's Irregularity Index, intercanine and intermolar widths, arch depth, passive extraction space) collected during the trial. No personal identifiers will be included. Supporting documents such as study protocol, statistical analysis plan, and analytic code will also be shared.
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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 Self-Ligating Brackets (SLB) and Conventional Bracket in people with Dental Crowding and Passive Extraction Space, run by Saidu College of Dentistry at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 31 Mar 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 Pakistan. 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?
Dental alignment assessed by Little's Irregularity Index (time frame: Baseline (T₀) to 9 months (T₃), assessed at 3-month intervals). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07503314, which also lists 2 linked publications.
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 31 Mar 2026.