Malocclusion Class INCT07878234
Self-ligating vs Conventional Brackets and Labial Bone Thickness During Crowding Correction in Adults
A study testing Self-ligating orthodontic brackets and Conventional orthodontic brackets in people with Malocclusion Class I and Crowding of Teeth, run by Future University in Egypt at 1 site in Egypt.
Trial summary
This randomized clinical trial compares two types of orthodontic brackets, self-ligating and conventional, in adults aged 18 to 25 with moderate crowding of the lower front teeth (4 to 8 mm). Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Malocclusion Class I, Crowding of Teeth
- What is being tested?
- Self-ligating orthodontic brackets and Conventional orthodontic brackets
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Mar 2023to 15 Aug 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 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18 to 25 years with a full set of permanent teeth
- Moderate lower anterior crowding (4 to 8 mm)
- Angle Class I malocclusion with skeletal Class I relationship
Who cannot join
- Medically compromised patients
- Skeletal discrepancies
- Periodontal problems
- Need for extraction as part of orthodontic treatment
- Patients taking medications
- Parafunctional habits (bruxism, tongue thrusting, mouth breathing)
- Nickel allergy
- Impacted lower teeth
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, 11817
About this study
Official title: Changes in the Labial Alveolar Bone Thickness Associated With Self-ligating vs Conventional Brackets Following Leveling and Alignment in Adult Patients With Moderate Anterior Crowding: A Randomized Clinical Trial
This randomized clinical trial compares two types of orthodontic brackets, self-ligating and conventional, in adults aged 18 to 25 with moderate crowding of the lower front teeth (4 to 8 mm). The main question is whether the type of bracket affects the thickness of the thin bone covering the front surface of the lower incisor roots (labial alveolar bone) during the leveling and alignment phase of treatment. Some clinicians claim that self-ligating brackets with light-force copper-nickel-titanium wires let the bone adapt and follow the teeth, while others report bone thinning with both systems. Twenty participants will be randomly assigned to self-ligating or conventional brackets. Bone thickness will be measured on cone beam computed tomography (CBCT) scans taken before treatment and at the end of leveling and alignment. The study will also compare the speed of alignment, changes in tooth inclination (torque and tip), pain, root resorption, and periodontal health between the two groups.
Read the detailed description
Dental crowding is one of the most common malocclusions. Non-extraction treatment is increasingly popular, but moving teeth beyond the alveolar housing can lead to bone dehiscence, fenestration, and gingival recession, especially in the lower incisor region. Self-ligating bracket systems are claimed to produce a "Frankel-like effect", in which low-friction brackets and light-force Cu-NiTi wires allow the arch to reshape physiologically with the alveolar bone following the teeth. Clinical evidence for this claim is limited and conflicting.
Design: Two-arm, parallel-group randomized clinical trial with a 1:1 allocation ratio, reported according to CONSORT guidelines, conducted at the Orthodontic Department clinic, Faculty of Oral and Dental Medicine, Future University in Egypt.
Null hypothesis: There is no difference in the change in lower labial alveolar bone thickness between self-ligating and conventional brackets.
Randomization: A computer-generated random sequence (Microsoft Excel RAND function) will be produced by the study supervisor. Allocation will be concealed in sealed, opaque, folded envelopes kept in a box at the secretary's office. Patients will draw an envelope before bonding.
Blinding: Operator and participants cannot be blinded. Outcome assessors will be blinded; patient identifiers will be removed from radiographs and models, and two assessors will measure independently.
Interventions:
Conventional group: 0.022-inch slot Roth prescription stainless steel brackets (American Orthodontics) with elastomeric ligatures. Wire sequence: 0.012 and/or 0.014-inch NiTi (chosen according to crowding), 0.016-inch NiTi, 0.016 x 0.022-inch NiTi, then 0.017 x 0.025-inch stainless steel for 4 weeks.
Self-ligating group: Roth prescription self-ligating brackets (American Orthodontics). Wire sequence: 0.014-inch Cu-NiTi for at least 10 weeks, 0.014 x 0.025-inch Cu-NiTi for at least 10 weeks, then 0.017 x 0.025-inch stainless steel customized to arch form for 4 weeks.
Patients will be reviewed monthly, with an intraoral scan at each visit. CBCT, standardized photographs, intraoral scans, and periodontal evaluation will be taken at baseline (T0) and at the end of leveling and alignment (T1).
Sample size: Using G*Power 3.1.9.7 with alpha 0.05, power 80%, and effect size d = 1.51 from a previous study, 16 participants are needed (8 per group), increased by 20% for dropout to 20 (10 per group).
Statistical analysis: Normality will be checked with Kolmogorov-Smirnov and Shapiro-Wilk tests. Normally distributed data will be compared with independent t-tests, and non-normal data with the Mann-Whitney U test. Categorical data will be analyzed with chi-square tests. Significance is set at p ≤ 0.05 (IBM SPSS Statistics v26). Intra- and inter-examiner reliability will be assessed with the intraclass correlation coefficient and kappa.
- Conditions
- Malocclusion Class I, Crowding of Teeth
- Being tested
- Self-ligating orthodontic brackets, Conventional orthodontic brackets
- Keywords
- Self-ligating brackets, conventional brackets, alveolar bone thickness, Little's irregularity index
- 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 orthodontic bracketsDevice
Self-ligating brackets (American Orthodontics, Roth prescription) bonded to the lower teeth with a light-force Cu-NiTi archwire sequence until leveling and alignment are complete. over a duration of 6 months
Conventional orthodontic bracketsDevice
Conventional stainless steel brackets (American Orthodontics, Roth prescription, 0.022 x 0.028" slot) ligated with elastomeric O-ties with a NiTi archwire sequence until leveling and alignment are complete. over a duration of 6 months
| Study group | Role | What they receive |
|---|---|---|
| Self-ligating brackets | Experimental | Lower arch leveling and alignment using Roth prescription self-ligating brackets with 0.014" Cu-NiTi, 0.014"x0.025" Cu-NiTi, then 0.017"x0.025" stainless steel archwires. over a duration of 6 months Receives: Device: Self-ligating orthodontic brackets |
| Conventional brackets | Active comparator | Lower arch leveling and alignment using 0.022" slot Roth prescription conventional brackets with elastomeric ligatures and 0.012"/0.014" NiTi, 0.016" NiTi, 0.016"x0.022" NiTi, then 0.017"x0.025" stainless steel archwires. over a duration of 6 months Receives: Device: Conventional orthodontic brackets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in labial alveolar bone thickness of lower anterior teeth
Labial bone thickness measured in millimeters on CBCT scans using 3Shape software, compared between baseline and end of leveling and alignment.
Measured: Baseline (T0) and end of leveling and alignment (T1), approximately 6 months
Secondary outcomes (6)
Rate of lower incisor alignment
Little's Irregularity Index (mm) measured on monthly digital intraoral scans using 3Shape software, expressed as mm per month.
Measured: Monthly from baseline to end of leveling and alignment, approximately 6 months
Change in torque of lower anterior teeth
Labiolingual inclination measured on CBCT in degrees (angular) and millimeters (linear) using 3Shape software.
Measured: T0 and T1, approximately 6 months
Change in tip of lower anterior teeth
Mesiodistal angulation measured on CBCT in degrees (angular) and millimeters (linear) using 3Shape software.
Measured: T0 and T1, approximately 6 months
Pain intensity
Visual analogue scale (0 to 10) recorded by participants.
Measured: At first archwire insertion, after 24 hours, after 7 days, then monthly until end of leveling and alignment which is approximately 6 months
Root resorption of lower anterior teeth
Graded on CBCT using the Levander and Malmgren 5-grade scoring system.
Measured: T0 and T1, approximately 6 months
Periodontal status
Probing depth (mm) and clinical attachment loss (mm) measured by the same periodontist.
Measured: T0 and T1, approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start12 Mar 2023
- Primary completion12 Mar 2024
- Study completion15 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malocclusion 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman mostafa, Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07878234
- Sponsor's protocol ID
- FUE.REC(12)/3-2023
- Status last verified
- Oct 2026
- First submitted
- 10 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be accessible only to the supervisors and principal investigator to protect participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in the Labial Alveolar Bone Thickness Associated With Self-ligating vs Conventional Brackets Following Leveling and Alignment in Adult Patients With Moderate Anterior Crowding: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07878234
- Acronym / sponsor ID
- FUE.REC(12)/3-2023
- Conditions
- Malocclusion Class I, Crowding of Teeth
- Keywords
- Self-ligating brackets, conventional brackets, alveolar bone thickness, Little's irregularity index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 12 Mar 2023 (actual)
- Primary completion
- 12 Mar 2024 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 16 Oct 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 randomized clinical trial compares two types of orthodontic brackets, self-ligating and conventional, in adults aged 18 to 25 with moderate crowding of the lower front teeth (4 to 8 mm). The main question is whether the type of bracket affects the thickness of the thin bone covering the front surface of the lower incisor roots (labial alveolar bone) during the leveling and alignment phase of treatment. Some clinicians claim that self-ligating brackets with light-force copper-nickel-titanium wires let the bone adapt and follow the teeth, while others report bone thinning with both systems. Twenty participants will be randomly assigned to self-ligating or conventional brackets. Bone thickness will be measured on cone beam computed tomography (CBCT) scans taken before treatment and at the end of leveling and alignment. The study will also compare the speed of alignment, changes in tooth inclination (torque and tip), pain, root resorption, and periodontal health between the two groups.
Detailed description
Dental crowding is one of the most common malocclusions. Non-extraction treatment is increasingly popular, but moving teeth beyond the alveolar housing can lead to bone dehiscence, fenestration, and gingival recession, especially in the lower incisor region. Self-ligating bracket systems are claimed to produce a "Frankel-like effect", in which low-friction brackets and light-force Cu-NiTi wires allow the arch to reshape physiologically with the alveolar bone following the teeth. Clinical evidence for this claim is limited and conflicting.
Design: Two-arm, parallel-group randomized clinical trial with a 1:1 allocation ratio, reported according to CONSORT guidelines, conducted at the Orthodontic Department clinic, Faculty of Oral and Dental Medicine, Future University in Egypt.
Null hypothesis: There is no difference in the change in lower labial alveolar bone thickness between self-ligating and conventional brackets.
Randomization: A computer-generated random sequence (Microsoft Excel RAND function) will be produced by the study supervisor. Allocation will be concealed in sealed, opaque, folded envelopes kept in a box at the secretary's office. Patients will draw an envelope before bonding.
Blinding: Operator and participants cannot be blinded. Outcome assessors will be blinded; patient identifiers will be removed from radiographs and models, and two assessors will measure independently.
Interventions:
Conventional group: 0.022-inch slot Roth prescription stainless steel brackets (American Orthodontics) with elastomeric ligatures. Wire sequence: 0.012 and/or 0.014-inch NiTi (chosen according to crowding), 0.016-inch NiTi, 0.016 x 0.022-inch NiTi, then 0.017 x 0.025-inch stainless steel for 4 weeks.
Self-ligating group: Roth prescription self-ligating brackets (American Orthodontics). Wire sequence: 0.014-inch Cu-NiTi for at least 10 weeks, 0.014 x 0.025-inch Cu-NiTi for at least 10 weeks, then 0.017 x 0.025-inch stainless steel customized to arch form for 4 weeks.
Patients will be reviewed monthly, with an intraoral scan at each visit. CBCT, standardized photographs, intraoral scans, and periodontal evaluation will be taken at baseline (T0) and at the end of leveling and alignment (T1).
Sample size: Using G*Power 3.1.9.7 with alpha 0.05, power 80%, and effect size d = 1.51 from a previous study, 16 participants are needed (8 per group), increased by 20% for dropout to 20 (10 per group).
Statistical analysis: Normality will be checked with Kolmogorov-Smirnov and Shapiro-Wilk tests. Normally distributed data will be compared with independent t-tests, and non-normal data with the Mann-Whitney U test. Categorical data will be analyzed with chi-square tests. Significance is set at p ≤ 0.05 (IBM SPSS Statistics v26). Intra- and inter-examiner reliability will be assessed with the intraclass correlation coefficient and kappa.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-ligating brackets | Experimental | Device: Self-ligating orthodontic bracketsLower arch leveling and alignment using Roth prescription self-ligating brackets with 0.014" Cu-NiTi, 0.014"x0.025" Cu-NiTi, then 0.017"x0.025" stainless steel archwires. over a duration of 6 months |
| Conventional brackets | Active comparator | Device: Conventional orthodontic bracketsLower arch leveling and alignment using 0.022" slot Roth prescription conventional brackets with elastomeric ligatures and 0.012"/0.014" NiTi, 0.016" NiTi, 0.016"x0.022" NiTi, then 0.017"x0.025" stainless steel archwires. over a duration of 6 months |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adults aged 18 to 25 years with a full set of permanent teeth
- Moderate lower anterior crowding (4 to 8 mm)
- Angle Class I malocclusion with skeletal Class I relationship
Key exclusion criteria (8 listed)
- Medically compromised patients
- Skeletal discrepancies
- Periodontal problems
- Need for extraction as part of orthodontic treatment
- Patients taking medications
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 orthodontic bracketsSelf-ligating brackets (American Orthodontics, Roth prescription) bonded to the lower teeth with a light-force Cu-NiTi archwire sequence until leveling and alignment are complete. over a duration of 6 months | Device | Self-ligating brackets |
| Conventional orthodontic bracketsConventional stainless steel brackets (American Orthodontics, Roth prescription, 0.022 x 0.028" slot) ligated with elastomeric O-ties with a NiTi archwire sequence until leveling and alignment are complete. over a duration of 6 months | Device | Conventional brackets |
Primary outcome
Change in labial alveolar bone thickness of lower anterior teeth
Time frame: Baseline (T0) and end of leveling and alignment (T1), approximately 6 months
Labial bone thickness measured in millimeters on CBCT scans using 3Shape software, compared between baseline and end of leveling and alignment.
6 secondary outcomes
Rate of lower incisor alignment
Time frame: Monthly from baseline to end of leveling and alignment, approximately 6 months
Change in torque of lower anterior teeth
Time frame: T0 and T1, approximately 6 months
Change in tip of lower anterior teeth
Time frame: T0 and T1, approximately 6 months
Pain intensity
Time frame: At first archwire insertion, after 24 hours, after 7 days, then monthly until end of leveling and alignment which is approximately 6 months
Root resorption of lower anterior teeth
Time frame: T0 and T1, approximately 6 months
Periodontal status
Time frame: T0 and T1, approximately 6 months
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 Oct 2026.
- Individual participant dataSharing planned: No. Data will be accessible only to the supervisors and principal investigator to protect participant confidentiality.
Related trials for Malocclusion Class I
Recruiting
Comparing 3D-Printed and Milled Titanium Plates in Jaw Surgery (Le Fort I): Accuracy and Operative Time
Malocclusion, Angle Class II, Malocclusion, Angle Class III
Recruiting
Diode Laser Versus LED for Maxillary Canine Retraction in Orthodontic Patients
Malocclusion Class I
Not yet recruiting
Clinical Comparison of Clear Aligners and Fixed Appliances in Dental Anterior Open Bite
Open Bite, Malocclusion Class I
Recruiting
Effect of Early Versus Late Premolar Extraction on Orthodontic Tooth Movement
Malocclusion Class II, Malocclusion, Angle Class I
Not yet recruiting
3D Printed Occlusal Splints for Intraoperative Use
Malocclusion, Angle Class I, Malocclusion, Angle Class II
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 orthodontic brackets and Conventional orthodontic brackets in people with Malocclusion Class I and Crowding of Teeth, 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 3 inclusion and 8 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 Oct 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?
Change in labial alveolar bone thickness of lower anterior teeth (time frame: Baseline (T0) and end of leveling and alignment (T1), approximately 6 months). 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 Oct 2026.