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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Crowding of Anterior Mandibular Teeth
• Intervention / Treatment: Device: Fixed pre-adjusted edgewise orthodontic appliance; Device: Clear aligner therapy

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Arab Emirates
  • Emirate of Sharjah
    • Sharjah city, Emirate of Sharjah, United Arab Emirates, 27272
      • University Dental Hospital Sharjah (UDHS_

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fixed labial braces group; Participants in this group will be treated with pre-adjusted fixed orthodontic appliances.	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.; Other Names: 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
Active Comparator: Clear aligner group; Participants in this group will receive clear aligners customized based on a digital model of each patient's dentition.	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.; Other Names: Clear aligners; Clear aligner therapy (CAT); Eon aligner

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Sharjah
• Investigators: Principal Investigator: Mais Medhat Sadek, BDS, MSc, PHD, Morth(RCSEd), University of Sharjah

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2023
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: October 31, 2024
• First Submitted That Met QC Criteria: December 9, 2024
• First Posted (Actual): December 12, 2024

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Efficacy; Clinical trial; Randomized Clinical Trial; Efficiency; Orthodontic Treatment; Clear Aligners; Fixed Pre-adjusted Edgewise Orthodontic Appliance; Periodontal Outcomes; Orthodontic alignment time; Occlusal outcomes
• Additional Relevant MeSH Terms: Dentistry; Orthodontic Appliances; Orthodontics; Orthodontic Appliances, Fixed
• Other Study ID Numbers: REC-23-05-13-01-PG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD collected throughout the trial
• IPD Sharing Time Frame: IPD will be available once the trial is finalized up to 3 years post recruitment
• IPD Sharing Access Criteria: Principle investigator and researchers will have access to all IPD collected throughout the trial once it has been depersonalized.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No