Efficiency, Efficacy, Periodontal and Occlusal Outcomes for Clear Aligners Versus Pre-adjusted Orthodontic Appliances in Moderately Crowded Lower Incisor Treatment: A Randomized Clinical
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Total alignment time
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with moderate-severe lower crowding (Little's irregularity index 4 to 9 mm), non-extraction treatment
- •Age range: 16-45 years old
- •Class I malocclusion
- •Full permanent dentition
- •No caries or periodontal disease
排除标准
- •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
研究组 & 干预措施
Fixed labial braces group
Participants in this group will be treated with pre-adjusted fixed orthodontic appliances.
干预措施: Fixed pre-adjusted edgewise orthodontic appliance (Device)
Clear aligner group
Participants in this group will receive clear aligners customized based on a digital model of each patient's dentition.
干预措施: Clear aligner therapy (Device)
结局指标
主要结局
Total alignment time
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
Symmetry of contact distribution
时间窗: Baseline, and after an average of 6 months
Symmetry of contact distribution as measured by the T-scan device.
Probing depth
时间窗: 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
时间窗: Baseline, after 3 months, and after 6 months
Plaque index to evaluate the level and rate of plaque formation on tooth surfaces
Gingival index
时间窗: 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
时间窗: 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.
次要结局
- BANA (Microbial-enzymatic N-benzoyl-DL-arginine-2-napthylamide) Score(Baseline, after 3 months, and after 6 months)
- Immunological Assay using ELISA(Baseline, after 3 months, and after 6 months)
- Total number of scheduled routine appointments and additional emergency visits(Through alignment, an average of 6 months)
- Missed appointment rate(Through alignment, an average of 6 months)
- Number of refinements(Through alignment, an average of 6 months)
- Bracket/ attachment failure rate(Through alignment, an average of 6 months)
- Chair side time(Through alignment, an average of 6 months)
- Treatment Efficiency Index(Through alignment, an average of 6 months)
- Patient's occlusal comfort level(Baseline, and after an average of 6 months, and after treatment an average of 1 year)
- Changes in mandibular incisor inclination(Baseline, and after an average of 6 months)
- Changes in the mandibular arch form(Baseline, and after an average of 6 months)
研究者
Mais Medhat Sadek AbdelAzim
Assistant Professor
University of Sharjah