Therapeutic Efficacy of Local Vitamin D Drug as an Adjunct to Mechanical Debridement in the Treatment of Periodontitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Periodontal Assessment
研究概览
简要总结
The proposed study aims to investigate the impact of adjunctive vitamin D gel application on gingival crevicular fluid levels of alkaline phosphatase and interleukin-8 in periodontitis patients undergoing phase 1 periodontal therapy. By elucidating the molecular mechanisms underlying the therapeutic effects of vitamin D, this research seeks to contribute to the development of more effective treatment strategies for periodontitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with attachment loss 3-4 mm
- •periodontal pocket ≤ 5 mm
排除标准
- •- Patients with sensitivity to the medication used in the study.
- •Patients with a history of antibiotic use or anti-inflammatory drugs during the previous 3 months prior to the study.
- •Patients with systemic diseases.
- •Pregnant and lactating females.
- •Smokers and tobacco chewers.
- •Patients not compliant with oral hygiene procedures.
研究组 & 干预措施
vitamin D3-loaded Poly lactic-co-glycolic acid nanoparticles gel adjunct to mechanical debridement
vitamin D3-loaded Poly lactic-co-glycolic acid nanoparticles gel adjunct to mechanical debridement, and Interleukin 8/alkaline phosphatase Elisa analysis Frequency: once a week for 8 consecutive weeks Dosage, up to periodontal pocket fil
干预措施: vitamin D loaded Poly lactic-co-glycolic acid nanoparticles gel (Dietary Supplement)
vitamin D3-loaded Poly lactic-co-glycolic acid nanoparticles gel adjunct to mechanical debridement
vitamin D3-loaded Poly lactic-co-glycolic acid nanoparticles gel adjunct to mechanical debridement, and Interleukin 8/alkaline phosphatase Elisa analysis Frequency: once a week for 8 consecutive weeks Dosage, up to periodontal pocket fil
干预措施: only mechanical debridement (Procedure)
vitamin D3 gel (regular non-nanoparticle form) as an adjunct to mechanical debridement.
vitamin D3 gel (regular non-nanoparticle form) as an adjunct to mechanical debridement, and Interleukin 8/alkaline phosphatase Elisa analysis Frequency: once a week for 8 consecutive weeks Dosage, up to periodontal pocket fil
干预措施: vitamin D3 gel (regular non-nanoparticle form) (Dietary Supplement)
vitamin D3 gel (regular non-nanoparticle form) as an adjunct to mechanical debridement.
vitamin D3 gel (regular non-nanoparticle form) as an adjunct to mechanical debridement, and Interleukin 8/alkaline phosphatase Elisa analysis Frequency: once a week for 8 consecutive weeks Dosage, up to periodontal pocket fil
干预措施: only mechanical debridement (Procedure)
Poly lactic-co-glycolic acid nanoparticles placebo gel adjunct to mechanical debridement.
Poly lactic-co-glycolic acid nanoparticles placebo gel adjunct to mechanical debridement, and Interleukin 8/alkaline phosphatase Elisa analysis Frequency: once a week for 8 consecutive weeks Dosage, up to periodontal pocket fil
干预措施: Poly lactic-co-glycolic acid nanoparticles placebo gel (Other)
Poly lactic-co-glycolic acid nanoparticles placebo gel adjunct to mechanical debridement.
Poly lactic-co-glycolic acid nanoparticles placebo gel adjunct to mechanical debridement, and Interleukin 8/alkaline phosphatase Elisa analysis Frequency: once a week for 8 consecutive weeks Dosage, up to periodontal pocket fil
干预措施: only mechanical debridement (Procedure)
only mechanical debridement only
only mechanical debridement only.
干预措施: only mechanical debridement (Procedure)
Healthy patients
healthy patients, only added for Interleukin 8 and alkaline phosphatase Elisa analysis
结局指标
主要结局
Periodontal Assessment
时间窗: 12 weeks
Periodontal Index
次要结局
- Interleukin 8(8 weeks)
- alkaline phosphatase(8 weeks)