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

University of Sharjah

Status: Invitation-only

Conditions: Crowding of Anterior Mandibular Teeth

Treatments: Device: Fixed pre-adjusted edgewise orthodontic appliance; Device: Clear aligner therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06731465

REC-23-05-13-01-PG

Details and patient eligibility

About

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.

Full 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).

Enrollment: 40 estimated patients

Sex: All

Ages: 13 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Fixed labial braces group

Active Comparator group

Description:

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

Treatment:

Device: Fixed pre-adjusted edgewise orthodontic appliance

Clear aligner group

Active Comparator group

Description:

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

Treatment:

Device: Clear aligner therapy