Probiotics as Adjunctive Therapy in the Management of Periodontitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Periodontal pocket depths
研究概览
简要总结
The goal of this clinical trials is to learn about the effect of taking Prodentis on a long term basis following periodontal therapy. The main question it aims to answer is
1. what is the effect of long-term consumption of Prodentis on regulating periodontal health and systemic immune-response, when compare to only taking it for 3 months post RSD?
详细描述
Following root surface debridement (RSD), subjects in the control group (group NP) will be instructed to take Prodentis® twice/day immediately for 3 months only then continue 3 monthly review until month 12th.
For subjects in the test group (group OP), following RSD, they will be instructed to take Prodentis® twice/day immediately for 3 months then continue Prodentis® once a day until month 12th. They will be reviewed 3 monthly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject has given their written consent to participate in the trial.
- •All subjects must be aged >18 years old, not pregnant, and presented with number of teeth > 12
- •Diagnosis for periodontitis Stage III and IV, will be according to 2017 the American Academy of Periodontology (AAP) and European Federation of Periodontology (EFP) classification
- •Has had 1 round of periodontal therapy within 3-6 months' time from recruitment date, and currently presented with at least 4 residual pockets with pocket depth 5mm and above.
排除标准
- 未提供
研究组 & 干预措施
OP group
Following root surface debridement (RSD), subjects in the test group (group OP) will be instructed to take Prodentis® twice/day immediately for 3 months then continue Prodentis® once a day until month 12th.
干预措施: Prodentis (Dietary Supplement)
NP group
Following root surface debridement (RSD), subjects in the control group (group NP) will be instructed to take Prodentis® twice/day immediately for 3 months then discontinue. The will be reviewed at similar intervals as the test group until month 12th.
干预措施: Prodentis (Dietary Supplement)
结局指标
主要结局
Periodontal pocket depths
时间窗: Baseline, 3 months, 6 months and 1 year
UNC-15 probe will be used to measure this outcome
次要结局
- Biomarkers from Serum and Saliva(The collection of saliva and serum will be done at baseline, 3 month and 6 months post RSD, and finally at 12 month.)
研究者
Dr CHEAH CHIA WEI
Dr
University of Malaya