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

Not Applicable

• Conditions: Crowding of Anterior Mandibular Teeth

• Registration Number: NCT06731465
• Lead Sponsor: University of Sharjah

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).

Study Timeline

• Study Start: 2023-10-16
• Study First Submitted: 2024-10-31
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-09
• Last Update Submitted: 2024-12-09
• Study First Posted: 2024-12-12
• Last Update Posted: 2024-12-12
• Primary Completion: 2026-12
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Symmetry of contact distribution	Baseline, and after an average of 6 months	Symmetry of contact distribution as measured by the T-scan device.
Total alignment time	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.
Bleeding on probing	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.
Occlusal contact surface area	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
Efficacy of clear aligners Vs fixed appliances in alignment of lower anterior teeth	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
Probing depth	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.
Plaque index	Baseline, after 3 months, and after 6 months	Plaque index to evaluate the level and rate of plaque formation on tooth surfaces
Gingival index	Baseline, after 3 months, and after 6 months	Gingival index to determine the severity of gingival inflammation with a score from 0 - 3
Total treatment time	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 Outcome Measures

Name	Time	Method
Total number of scheduled routine appointments and additional emergency visits	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.
Missed appointment rate	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.
Number of refinements	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
Bracket/ attachment failure rate	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).
Chair side time	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.
Treatment Efficiency Index	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.
BANA (Microbial-enzymatic N-benzoyl-DL-arginine-2-napthylamide) Score	Baseline, after 3 months, and after 6 months	Microbiological index for the subgingival plaque
Immunological Assay using ELISA	Baseline, after 3 months, and after 6 months	Immunological assay cytokine IL-1Beta in the gingival crevicular fluid
Patient's occlusal comfort level	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
Changes in mandibular incisor inclination	Baseline, and after an average of 6 months	Changes in mandibular incisor inclination as measured on the lateral cephalogram
Changes in the mandibular arch form	Baseline, and after an average of 6 months	Changes in the mandibular arch form as measured on the study model

Trial Locations

Locations (1)

University Dental Hospital Sharjah (UDHS_; 🇦🇪 Sharjah, United Arab Emirates