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Crowding of Anterior Mandibular TeethNCT06731465

Efficiency, Efficacy, Periodontal & Occlusal Outcomes for Aligners Versus Fixed Orthodontic Appliances in Crowded Incisor Treatment

A study testing Clear aligner therapy and Fixed pre-adjusted edgewise orthodontic appliance in people with Crowding of Anterior Mandibular Teeth, run by University of Sharjah at 1 site in United Arab Emirates.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to compare between fixed labial braces and clear aligners for the straightening of moderately overlapped lower front teeth. The main questions it aims to answer are: Effect of treatment on gum health Which treatment achieves lower front teeth alignment faster in terms of alignment… Read more about this study

Who is it for?
Ages 16 to 45 years
Conditions the study is for
Crowding of Anterior Mandibular Teeth
What is being tested?
Clear aligner therapy and Fixed pre-adjusted edgewise orthodontic appliance
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited Arab Emirates
Study dates
16 Oct 2023to Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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 16 to 45 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Patients with moderate-severe lower crowding (Little's irregularity index 4 to 9 mm), non-extraction treatment
  • Age range: 16-45 years old
  • Class I malocclusion
  • Full permanent dentition
  • No caries or periodontal disease

Who cannot join

  • Extraction cases
  • Patients with craniofacial syndromes, or cleft palate
  • Patients with uncontrolled medical conditions or taking medication that can interfere with orthodontic tooth movement.
  • Presence of extensive dental restorations in proximity to the gingival margin
  • Presence of fixed bridges/crowns or partial dentures

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United Arab Emirates1 site
  • University Dental Hospital Sharjah (UDHS_

    Sharjah city, Emirate of Sharjah, 27272

Other trials in United Arab Emirates

About this study

Official title: Efficiency, Efficacy, Periodontal and Occlusal Outcomes for Clear Aligners Versus Pre-adjusted Orthodontic Appliances in Moderately Crowded Lower Incisor Treatment: A Randomized Clinical

The goal of this clinical trial is to compare between fixed labial braces and clear aligners for the straightening of moderately overlapped lower front teeth. The main questions it aims to answer are:

  • Effect of treatment on gum health
  • Which treatment achieves lower front teeth alignment faster in terms of alignment time and t number of visits required to the orthodontist
  • How well it straightens teeth.
Read more

Participants will:

  • Receive either labial braces or clear aligners as part of their orthodontic treatment.
  • Come for regular follow-up visits every 4 to 6 weeks with the orthodontist till full straightening of the lower front teeth.
  • Have a 3D scan of their teeth taken after their teeth are aligned along with a specialized x-ray of their head and jaw.
Read the detailed description

The study is a randomized controlled trial aimed at comparing the efficiency, efficacy, periodontal and occlusal outcomes between two orthodontic treatment options: clear aligners and traditional fixed braces for patients with moderate crowding in the lower incisors.

Pre-treatment diagnostic records including clinical examination, intraoral scans, intraoral and extraoral photographs will be obtained for each participant.

To ensure that participants in both groups have similar levels of crowding severity and comparable dental health characteristics at the start of the study, randomization will be conducted in blocks. A total of forty participants (20 in each group) will be selected according to specific criteria designed to maintain this uniformity across both treatment groups.This study follows a parallel-group design and the participants will be randomly allocated into one of the two groups included in the study:

Intervention Groups:

  • Group A - Fixed Labial Braces (Master Series®, American Orthodontics): In the traditional braces group, fixed metal brackets will be bonded to the lower teeth, and archwires will be used in a specific sequence designed to bring the teeth into alignment over time.
  • Group B - Clear Aligners (EON Aligner): The clear aligner group will receive custom-fitted aligners created using a digital model of each participant's teeth. These aligners are removable, requiring patient adherence to wearing them for at least 22 hours daily.

Primary Outcomes:

  1. Total alignment time
  2. Clinical measures of periodontal status
  3. Occlusal contact distribution
  4. Efficacy of clear aligners Vs fixed appliances in alignment of lower anterior teeth

Secondary Outcomes:

  1. Total number of scheduled routine appointments and additional emergency visits
  2. Missed appointment rate
  3. Number of refinements
  4. Bracket/ attachment failure rate
  5. Chair-side Time
  6. Treatment Efficiency Index
  7. BANA (Microbial-enzymatic N-benzoyl-DL-arginine-2-napthylamide) Score
  8. Immunological Assay using ELISA
  9. Patient's occlusal comfort level
  10. Changes in mandibular incisor inclination
  11. Changes in the mandibular arch form

Data will be analyzed using SPSS (Statistical Package for the Social Sciences) software, with statistical tests appropriate to the variable types (e.g., Mann-Whitney for group comparisons and Wilcoxon Signed-Rank test for time-related variables).

Being tested
Clear aligner therapy, Fixed pre-adjusted edgewise orthodontic appliance
Keywords
Clinical trial, Clear Aligners, Fixed Pre-adjusted Edgewise Orthodontic Appliance, Orthodontic Treatment, Efficiency, Efficacy, Periodontal Outcomes, Randomized Clinical Trial, Orthodontic alignment time, Occlusal outcomes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Clear aligner therapyDevice

    Also called Clear aligners, Clear aligner therapy (CAT), Eon aligner

    Participants in this group will receive clear aligners (EON Aligner, Minneapolis), designed and customized based on a digital model of each patient's dental structure. Aligners will be worn for at least 22 hours daily, and patients will change to a new aligner depending on treatment progress.

  • Fixed pre-adjusted edgewise orthodontic applianceDevice

    Also called Fixed orthodontic appliance, Fixed labial braces, Conventional braces, Edgewise appliance

    Participants in this group will be treated with pre-adjusted fixed orthodontic appliances (Master Series®, American Orthodontics™, WI, USA). This system includes fixed brackets bonded on the labial surface of teeth and a sequence of progressively larger arch wires aimed at achieving alignment over time.

Study groups in NCT06731465
Study groupRoleWhat they receive
Fixed labial braces groupActive comparatorParticipants in this group will be treated with pre-adjusted fixed orthodontic appliances.
Receives: Device: Fixed pre-adjusted edgewise orthodontic appliance
Clear aligner groupActive comparatorParticipants in this group will receive clear aligners customized based on a digital model of each patient's dentition.
Receives: Device: Clear aligner therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total alignment time

    The duration of treatment time (rounded to the nearest day) required to achieve full alignment of the mandibular incisors determined clinically as <1mm little's irregularity index, evaluated for both treatment groups. This information is to be extracted from participant notes into a data collection sheet designed specifically for this study.

    Measured: Through alignment, an average of 6 months

  2. Bleeding on probing

    Bleeding on probing as an indicator of tissue inflammatory response to bacterial pathogensis, using the Michigan Williams probe assigned a score of 0 - 3 for each site.

    Measured: Baseline, after 3 months, and after 6 months

  3. Occlusal contact surface area

    Occlusal contact surface area as measured by the T-scan device in terms of no. of pixels

    Measured: Baseline, and after an average of 6 months, and after treatment an average of 1 year

  4. Efficacy of clear aligners Vs fixed appliances in alignment of lower anterior teeth

    Efficacy of clear aligners Vs fixed appliances in alignment of lower anterior teeth using Little's irregularity index

    Measured: Baseline, and after an average of 6 months

  5. Symmetry of contact distribution

    Symmetry of contact distribution as measured by the T-scan device.

    Measured: Baseline, and after an average of 6 months

  6. Probing depth

    The distance measured from the base of the pocket to the most apical point on the gingival margin using the Michigan Williams probe.

    Measured: Baseline, after 3 months, and after 6 months

  7. Plaque index

    Plaque index to evaluate the level and rate of plaque formation on tooth surfaces

    Measured: Baseline, after 3 months, and after 6 months

  8. Gingival index

    Gingival index to determine the severity of gingival inflammation with a score from 0 - 3

    Measured: Baseline, after 3 months, and after 6 months

  9. Total treatment time

    The duration of treatment time (rounded to the nearest day) required to complete treatment, evaluated for both treatment groups. This information is to be extracted from participant notes into a data collection sheet designed specifically for this study.

    Measured: Through treatment, an average of 1 year

Secondary outcomes (11)
  1. Total number of scheduled routine appointments and additional emergency visits

    The number of scheduled routine appointments required to achieve full mandibular incisor alignment and additional visits for emergencies as recorded in participants' notes and the data collection sheet.

    Measured: Through alignment, an average of 6 months

  2. Missed appointment rate

    The number of scheduled routine appointments that the patient failed to attend during the alignment phase of treatment as recorded in both participants' notes and the data collection sheet.

    Measured: Through alignment, an average of 6 months

  3. Number of refinements

    If any of the participants required a refinement scan prior to completion of leveling and alignment of the mandibular incisors, this would be recorded in both participants' notes and the data collection sheet

    Measured: Through alignment, an average of 6 months

  4. Bracket/ attachment failure rate

    Adverse events i.e., bracket failure rate in Group A and attachment failure rate in Group B were recorded in both participants' notes and the data collection sheet. The patient's provider noted in the clinical chart every bracket that had bond failure during the course of the study trial period. The brackets on the molar teeth were omitted. Brackets that debonded twice or more on the same tooth were counted only once. At the end of 180 days post-bonding, the percentage of broken brackets was calculated as: number of debonded brackets divided by the total number of teeth bonded (excluding molar teeth).

    Measured: Through alignment, an average of 6 months

  5. Chair side time

    The average time taken at the initial banding and bonding visit for the group A and the initial attachment bonding and aligner delivery visit for group B along with multiple routine mid-treatment appointments for both the groups during the alignment phase of treatment, as well as one emergency appointment for both measured using a digital stopwatch. The appointment times were rounded to the nearest minute with the total chair side time beginning when the patient sits on the chair and ending when they stood up to leave.

    Measured: Through alignment, an average of 6 months

  6. Treatment Efficiency Index

    The treatment efficiency index calculated by measuring the average Little's irregularity index before treatment and dividing it by the average treatment time in months/ days for alignment of the mandibular incisors.

    Measured: Through alignment, an average of 6 months

  7. BANA (Microbial-enzymatic N-benzoyl-DL-arginine-2-napthylamide) Score

    Microbiological index for the subgingival plaque

    Measured: Baseline, after 3 months, and after 6 months

  8. Immunological Assay using ELISA

    Immunological assay cytokine IL-1Beta in the gingival crevicular fluid

    Measured: Baseline, after 3 months, and after 6 months

  9. Patient's occlusal comfort level

    Patient's occlusal comfort level assessed by means of a Visual Analog Scale with a score from 0 - 10, 0 being least comfortable and 10 being most comfortable

    Measured: Baseline, and after an average of 6 months, and after treatment an average of 1 year

  10. Changes in mandibular incisor inclination

    Changes in mandibular incisor inclination as measured on the lateral cephalogram

    Measured: Baseline, and after an average of 6 months

  11. Changes in the mandibular arch form

    Changes in the mandibular arch form as measured on the study model

    Measured: Baseline, and after an average of 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 posted12 Dec 2024
  2. Study start16 Oct 2023
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2028 (estimated)

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
Model description
The interventional study model used in this study is a two-arm, parallel-group, randomized controlled trial (RCT) with a 1:1 allocation ratio between two treatment arms: clear aligners and fixed braces. The study is structured to evaluate the treatment efficiency, efficacy and periodontal as well as occlusal parameters in participants treated with fixed labial braces or clear aligners for alignment of moderately crowded lower incisors. Block randomization is used to ensure an equal number of participants in each group, reducing potential imbalances in group size and baseline characteristics. Both groups will have regular progress checks every 4-6weeks, with adjustments or new aligners provided based on treatment progression.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06731465
Sponsor's protocol ID
REC-23-05-13-01-PG
Status last verified
Apr 2026
First submitted
31 Oct 2024
Last updated
11 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All IPD collected throughout the trial

Publications

  • Buschang PH, Shaw SG, Ross M, Crosby D, Campbell PM. Comparative time efficiency of aligner therapy and conventional edgewise braces. Angle Orthod. 2014 May;84(3):391-6. doi: 10.2319/062113-466. Epub 2013 Nov 18.

    PubMed 24749702

Questions about this trial

What is this clinical trial studying?

A study testing Clear aligner therapy and Fixed pre-adjusted edgewise orthodontic appliance in people with Crowding of Anterior Mandibular Teeth, run by University of Sharjah at 1 site in United Arab Emirates.

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 5 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 11 Aug 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 United Arab Emirates. 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?

This study is still under way. Results are not available in the source record yet.

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?

Total alignment time (time frame: Through alignment, an average of 6 months). The study lists 9 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 NCT06731465, which also lists 1 linked publication.

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 11 Aug 2026.

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