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OpenTrials
Enrolling by Invitation

NCT Number: NCT06731465

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

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.

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.

Enrolling by Invitation

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Key information

Conditions

Crowding of Anterior Mandibular Teeth

Age range

13 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Dental Hospital Sharjah (UDHS_

Sharjah city, Emirate of Sharjah, 27272, United Arab Emirates

About this study

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:

  • Total alignment time
  • Clinical measures of periodontal status
  • Occlusal contact distribution
  • Efficacy of clear aligners Vs fixed appliances in alignment of lower anterior teeth

Secondary Outcomes:

  • Total number of scheduled routine appointments and additional emergency visits
  • Missed appointment rate
  • Number of refinements
  • Bracket/ attachment failure rate
  • Chair-side Time
  • Treatment Efficiency Index
  • BANA (Microbial-enzymatic N-benzoyl-DL-arginine-2-napthylamide) Score
  • Immunological Assay using ELISA
  • Patient's occlusal comfort level
  • Changes in mandibular incisor inclination
  • 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).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with moderate lower crowding (Little's 4 to 6 mm), non-extraction treatment
  • Age range: 13-45 years old
  • Class I malocclusion
  • Full permanent dentition
  • No caries or periodontal disease

Exclusion criteria

  • 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

Treatment and study plan

Clear aligner therapy

Device

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.

Other names: Clear aligners, Clear aligner therapy (CAT), Eon aligner

Fixed pre-adjusted edgewise orthodontic appliance

Device

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.

Other names: Fixed orthodontic appliance, Fixed labial braces, Conventional braces, Edgewise appliance, Fixed Appliance, Pre-adjusted Appliance, Straight-wire Appliance, Fixed Braces, Fixed Orthodontic Braces, Pre-adjusted Edgewise Bracket System, Straight-wire Bracket System, Fixed Multibracket Appliance, Fixed Straight-wire Technique

Primary outcomes

  1. Total alignment time

    Time frame: Through alignment, an average of 6 months

    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.

  2. Bleeding on probing

    Time frame: Baseline, after 3 months, and after 6 months

    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.

  3. Occlusal contact surface area

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

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

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

    Time frame: Baseline, and after an average of 6 months

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

  5. Symmetry of contact distribution

    Time frame: Baseline, and after an average of 6 months

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

  6. Probing depth

    Time frame: Baseline, after 3 months, and after 6 months

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

  7. Plaque index

    Time frame: Baseline, after 3 months, and after 6 months

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

  8. Gingival index

    Time frame: Baseline, after 3 months, and after 6 months

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

  9. Total treatment time

    Time frame: Through treatment, an average of 1 year

    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.

Secondary outcomes

  1. Total number of scheduled routine appointments and additional emergency visits

    Time frame: Through alignment, an average of 6 months

    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.

  2. Missed appointment rate

    Time frame: Through alignment, an average of 6 months

    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.

  3. Number of refinements

    Time frame: Through alignment, an average of 6 months

    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

  4. Bracket/ attachment failure rate

    Time frame: Through alignment, an average of 6 months

    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).

  5. Chair side time

    Time frame: Through alignment, an average of 6 months

    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.

  6. Treatment Efficiency Index

    Time frame: Through alignment, an average of 6 months

    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.

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

    Time frame: Baseline, after 3 months, and after 6 months

    Microbiological index for the subgingival plaque

  8. Immunological Assay using ELISA

    Time frame: Baseline, after 3 months, and after 6 months

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

  9. Patient's occlusal comfort level

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

    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

  10. Changes in mandibular incisor inclination

    Time frame: Baseline, and after an average of 6 months

    Changes in mandibular incisor inclination as measured on the lateral cephalogram

  11. Changes in the mandibular arch form

    Time frame: Baseline, and after an average of 6 months

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

Sponsors and collaborators

Lead sponsor

University of Sharjah

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Dec 12, 2024
Registry last updated
May 5, 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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