NCT06731465

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

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Sharjah · Academic / Other
• Sex: All
• Age: 13 Years – 45 Years
• Healthy volunteers: Not accepted

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.

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).

Conditions

• Crowding of Anterior Mandibular Teeth

Interventions

Type	Name	Description
DEVICE	Clear aligner therapy	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.
DEVICE	Fixed pre-adjusted edgewise orthodontic 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.

Timeline

• Start date: 2023-10-16
• Primary completion: 2026-12-01
• Completion: 2027-06-01
• First posted: 2024-12-12
• Last updated: 2024-12-12

Locations

1 site across 1 country: United Arab Emirates