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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:
Participants will:
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:
Primary Outcomes:
Secondary Outcomes:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fixed labial braces group | Active Comparator | Participants in this group will be treated with pre-adjusted fixed orthodontic appliances. |
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| Clear aligner group | Active Comparator | Participants in this group will receive clear aligners customized based on a digital model of each patient's dentition. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clear aligner therapy | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mais Medhat Sadek, BDS, MSc, PHD, Morth(RCSEd) | University of Sharjah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Dental Hospital Sharjah (UDHS_ | Sharjah city | Emirate of Sharjah | 27272 | United Arab Emirates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24749702 | Result | 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. |
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All IPD collected throughout the trial
IPD will be available once the trial is finalized up to 3 years post recruitment
Principle investigator and researchers will have access to all IPD collected throughout the trial once it has been depersonalized.
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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.
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| Fixed pre-adjusted edgewise orthodontic appliance | 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. |
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| 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 |
| 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 |
| ID | Term |
|---|---|
| D000077744 | Orthodontic Appliances, Fixed |
| ID | Term |
|---|---|
| D009967 | Orthodontic Appliances |
| D009970 | Orthodontics |
| D003813 | Dentistry |
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