CTRI/2024/03/064247已完成2/3 期
Effect of folic acid supplementation on periodontal status, gingival biotype and keratinized gingival width in subjects undergoing fixed orthodontic therapy
Dr Iman Ahmad1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年3月25日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Periodontal status, gingival biotype and keratinised gingival width
研究概览
简要总结
Fixed orthodontic appliances impede proper oral hygiene, resulting in increased plaque accumulation and patient’s risk of periodontal inflammation. Studies have shown that folic acid supplementation results in significant reduction in gingival inflammation. This study aims to evaluate the effect of systemic folic acid supplementation on the periodontal condition of subjects undergoing fixed orthodontic therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 13.00 Year(s) 至 25.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients having complete permanent dentition and undergoing fixed orthodontic mechanotherapy
- •Planned for premolar extractions in all 4 quadrants, followed by anterior retraction in maxillary and mandibular arches
- •Gingivitis in the anterior region after levelling and alignment stage of treatment (as per AAP 2018 classification).
排除标准
- •Previous functional orthopaedic and/or fixed orthodontic treatment
- •Destructive periodontal disease and/or gingival recession before treatment
- •Received periodontal treatment within the previous year
- •Iron/vitamin supplement(s) within the previous 6 months
- •Systemic conditions with related medications
- •Pregnancy and lactation 7.
结局指标
主要结局
Periodontal status, gingival biotype and keratinised gingival width
时间窗: T0 baseline- after levelling and alignment of teeth, T1- after 4 months of anterior retraction, T2- after complete anterior retraction
次要结局
- Serum folate estimation(T0 baseline- after levelling and alignment of teeth, T1- after 4 months of anterior retraction, T2- after complete anterior retraction)
- Rate of orthodontic tooth movement(T0 baseline- after levelling and alignment of teeth, T1- after 4 months of anterior retraction, T2- after complete anterior retraction)
研究者
Iman Ahmad
Aligarh Muslim University, Aligarh
研究点 (1)
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