Evaluating the efficacy of Herbal extracts in preventing post-orthodontic relapse
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- To assess the efficacy of herbal extract on the stability of orthodontic treated patients.
研究概览
简要总结
This randomized controlled clinical trial is designed to evaluate the efficacy of selected herbal extracts in preventing post-orthodontic relapse among patients with Class I malocclusion who have completed fixed orthodontic treatment. A total of 52 participants aged 15–28 years, meeting the inclusion and exclusion criteria, will be randomly allocated into intervention and control groups. The intervention group will receive herbal extract–based formulations in addition to standard retention protocol, while the control group will receive standard retention protocol alone.
The primary outcome will be reduction in post-treatment relapse measured by Little’s Irregularity Index at baseline, 1 and 3 months. Secondary outcomes will include changes in gingival index and patient-reported comfort and compliance. Safety outcomes and adverse events will also be monitored at each follow-up visit.
This study will provide preliminary clinical evidence on the role of herbal extracts as a supportive adjunct in orthodontic retention and relapse prevention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 15.00 Year(s) 至 28.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients in the age group of 15 to 28 years.
- •Patient with erupted all permanent teeth except 3rd molars
- •Patient with good general health.
- •Patients voluntarily involved in the study.
- •Patients having skeletal class I and dental class I with moderate to severe crowing and/or spacing.
排除标准
- •Patients with syndromes or systemic diseases (Diabetes or any bone disorders)
- •Patients in pregnancy.
- •Patients with allergic to any ingredients in the herbal products.
- •Patients with multiple prosthesis.
- •Patients with periodontally compromised teeth.
- •Patients taking any nutrition supplements or drugs.
结局指标
主要结局
To assess the efficacy of herbal extract on the stability of orthodontic treated patients.
时间窗: Baseline (Day 0;after archwire removal), and after 3 months (±14 days).
次要结局
- To assess the effectiveness of herbal extracts on gingival health in orthodontically treated patients(Baseline (Day 0;after archwire removal), and after 3 months (±14 days).)
研究者
Dr Pravinkumar
CSMSS DENTAL COLLEGE AND HOSPITAL