Clinical trial NCT06731465: Efficiency, Efficacy, Periodontal & Occlusal Outcomes for Aligners Versus Fixed Orthodontic Appliances in Crowded Incisor Treatment
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
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
Lead sponsor: University of Sharjah
Sponsor class: OTHER
First posted: 2024-12-12
Enrollment: 40
Sex: ALL
Minimum age (years): 13
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Total alignment time
timeFrame: Through alignment, an average of 6 months
measure: Bleeding on probing
timeFrame: Baseline, after 3 months, and after 6 months
measure: Occlusal contact surface area
timeFrame: Baseline, and after an average of 6 months, and after treatment an average of 1 year
measure: Efficacy of clear aligners Vs fixed appliances in alignment of lower anterior teeth
timeFrame: Baseline, and after an average of 6 months
measure: Symmetry of contact distribution
timeFrame: Baseline, and after an average of 6 months
measure: Probing depth
timeFrame: Baseline, after 3 months, and after 6 months
measure: Plaque index
timeFrame: Baseline, after 3 months, and after 6 months
measure: Gingival index
timeFrame: Baseline, after 3 months, and after 6 months
measure: Total treatment time
timeFrame: Through treatment, an average of 1 year
Secondary outcomes:
measure: Total number of scheduled routine appointments and additional emergency visits
timeFrame: Through alignment, an average of 6 months
measure: Missed appointment rate
timeFrame: Through alignment, an average of 6 months
measure: Number of refinements
timeFrame: Through alignment, an average of 6 months
measure: Bracket/ attachment failure rate
timeFrame: Through alignment, an average of 6 months
measure: Chair side time
timeFrame: Through alignment, an average of 6 months
measure: Treatment Efficiency Index
timeFrame: Through alignment, an average of 6 months
measure: BANA (Microbial-enzymatic N-benzoyl-DL-arginine-2-napthylamide) Score
timeFrame: Baseline, after 3 months, and after 6 months
measure: Immunological Assay using ELISA
timeFrame: Baseline, after 3 months, and after 6 months
measure: Patient's occlusal comfort level
timeFrame: Baseline, and after an average of 6 months, and after treatment an average of 1 year
measure: Changes in mandibular incisor inclination
timeFrame: Baseline, and after an average of 6 months
measure: Changes in the mandibular arch form
timeFrame: Baseline, and after an average of 6 months
Other outcomes:
Locations:
city: Sharjah
country: United Arab Emirates
facility: University Dental Hospital Sharjah (UDHS_
Study officials:
affiliation: University of Sharjah
name: Mais Medhat Sadek, BDS, MSc, PHD, Morth(RCSEd)
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.