Efficiency, Efficacy, Periodontal & Occlusal Outcomes for Aligners Versus Fixed Orthodontic Appliances in Crowded Incisor Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Clear aligner therapy, Fixed pre-adjusted edgewise orthodontic appliance.
- Who it may be relevant to
- Registry conditions: Crowding of Anterior Mandibular Teeth. Basic parameters: 13 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Arab Emirates
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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).
Interventions
- 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. - 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.
Primary outcome measures
- Total alignment time [Time frame: Through alignment, an average of 6 months]
- Bleeding on probing [Time frame: Baseline, after 3 months, and after 6 months]
- Occlusal contact surface area [Time frame: 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 [Time frame: Baseline, and after an average of 6 months]
- Symmetry of contact distribution [Time frame: Baseline, and after an average of 6 months]
- Probing depth [Time frame: Baseline, after 3 months, and after 6 months]
- Plaque index [Time frame: Baseline, after 3 months, and after 6 months]
- Gingival index [Time frame: Baseline, after 3 months, and after 6 months]
- Total treatment time [Time frame: Through treatment, an average of 1 year]
Secondary outcome measures (11)
- Total number of scheduled routine appointments and additional emergency visits [Time frame: Through alignment, an average of 6 months]
- Missed appointment rate [Time frame: Through alignment, an average of 6 months]
- Number of refinements [Time frame: Through alignment, an average of 6 months]
- Bracket/ attachment failure rate [Time frame: Through alignment, an average of 6 months]
- Chair side time [Time frame: Through alignment, an average of 6 months]
- Treatment Efficiency Index [Time frame: Through alignment, an average of 6 months]
- BANA (Microbial-enzymatic N-benzoyl-DL-arginine-2-napthylamide) Score [Time frame: Baseline, after 3 months, and after 6 months]
- Immunological Assay using ELISA [Time frame: Baseline, after 3 months, and after 6 months]
- Patient's occlusal comfort level [Time frame: Baseline, and after an average of 6 months, and after treatment an average of 1 year]
- Changes in mandibular incisor inclination [Time frame: Baseline, and after an average of 6 months]
- Changes in the mandibular arch form [Time frame: Baseline, and after an average of 6 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United Arab Emirates · 1 center
- University Dental Hospital Sharjah (UDHS_ — Sharjah city
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. PMID 24749702
Identifiers
NCT: NCT06731465 · REC-23-05-13-01-PG