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

NCT ID: NCT06731465

Last Updated: 2024-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-16

Study Completion Date

2027-06-30

Brief Summary

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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

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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

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Crowding of Anterior Mandibular Teeth

Keywords

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Clinical trial Clear Aligners Fixed Pre-adjusted Edgewise Orthodontic Appliance Orthodontic Treatment Efficiency Efficacy Periodontal Outcomes Randomized Clinical Trial Orthodontic alignment time Occlusal outcomes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Fixed labial braces group

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

Group Type ACTIVE_COMPARATOR

Fixed pre-adjusted edgewise orthodontic appliance

Intervention Type DEVICE

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.

Clear aligner group

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

Group Type ACTIVE_COMPARATOR

Clear aligner therapy

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

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Clear aligners Clear aligner therapy (CAT) Eon aligner 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

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sharjah

OTHER

Sponsor Role lead

Responsible Party

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Mais Medhat Sadek AbdelAzim

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mais Medhat Sadek, BDS, MSc, PHD, Morth(RCSEd)

Role: PRINCIPAL_INVESTIGATOR

University of Sharjah

Locations

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University Dental Hospital Sharjah (UDHS_

Sharjah city, Ash Shāriqah, United Arab Emirates

Site Status

Countries

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United Arab Emirates

References

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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.

Reference Type BACKGROUND
PMID: 24749702 (View on PubMed)

Other Identifiers

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REC-23-05-13-01-PG

Identifier Type: -

Identifier Source: org_study_id