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

NCT06731465 | Enrolling By Invitation

• 1 other identifier: REC-23-05-13-01-PG
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Crowding of Anterior Mandibular Teeth

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

Outcome Measures

Primary Outcomes (9)

• 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.

  Through alignment, an average of 6 months

• 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.

  Baseline, after 3 months, and after 6 months

• Occlusal contact surface area

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

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

• 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

  Baseline, and after an average of 6 months

• Symmetry of contact distribution

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

  Baseline, and after an average of 6 months

• 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.

  Baseline, after 3 months, and after 6 months

• Plaque index

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

  Baseline, after 3 months, and after 6 months

• Gingival index

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

  Baseline, after 3 months, and after 6 months

• 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.

  Through treatment, an average of 1 year

Secondary Outcomes (11)

• Total number of scheduled routine appointments and additional emergency visits

  Through alignment, an average of 6 months

• Missed appointment rate

  Through alignment, an average of 6 months

• Number of refinements

  Through alignment, an average of 6 months

• Bracket/ attachment failure rate

  Through alignment, an average of 6 months

• Chair side time

  Through alignment, an average of 6 months

Study Arms (2)

Fixed labial braces group

ACTIVE COMPARATOR

Participants in this group will be treated with pre-adjusted fixed orthodontic appliances.

Device: Fixed pre-adjusted edgewise orthodontic appliance

Clear aligner group

ACTIVE COMPARATOR

Participants in this group will receive clear aligners customized based on a digital model of each patient's dentition.

Device: Clear aligner therapy

Interventions

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.

Also known as: Clear aligners, Clear aligner therapy (CAT), Eon aligner

Clear aligner group

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.

Also known as: 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

Fixed labial braces group

Eligibility Criteria

• Age: 13 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sharjah: lead

Study Sites (1)

University Dental Hospital Sharjah (UDHS_

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

Location

Related Publications (1)

• 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.

  PMID: 24749702 RESULT

MeSH Terms

Interventions

Orthodontic Appliances, Fixed

Intervention Hierarchy (Ancestors)

Orthodontic Appliances; Orthodontics; Dentistry

Study Officials

• Mais Medhat Sadek, BDS, MSc, PHD, Morth(RCSEd)

  University of Sharjah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: December 12, 2024
• Study Start: October 16, 2023
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD will be available once the trial is finalized up to 3 years post recruitment
• Access Criteria: Principle investigator and researchers will have access to all IPD collected throughout the trial once it has been depersonalized.

Locations

AE (1)