AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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

Other trials in Egypt

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.

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 groups in NCT07878234
Study groupRoleWhat they receive
Self-ligating bracketsExperimentalLower 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 bracketsActive comparatorLower 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  1. First posted16 Oct 2026
  2. Study start12 Mar 2023
  3. Primary completion12 Mar 2024
  4. Study completion15 Aug 2025

Resources

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)
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.

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.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in