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临床试验/CTRI/2025/11/097407
CTRI/2025/11/097407尚未招募2/3 期

Evaluation and comparison of the usage of a novel prebiotic as an adjunct to Scaling and Root Planing in the treatment of periodontitis A randomized controlled clinical trial.

Terna Dental College and Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年11月24日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
Is there any beneficial effect in usage of a novel prebiotic as an adjunct to SRP in reducing the inflammation in chronic periodontitis compared to the SRP alone?

研究概览

简要总结

TITLE- Evaluation And Comparison Of The Usage Of A Novel Prebiotic As An Adjunct To Scaling And Root Planing (SRP) Versus SRP Alone In The Non-Surgical Treatment Of Chronic Periodontitis: A Pilot Study.

 INTRODUCTION- Host modulation using prebiotics like high-molecular-weight inulin enhances gut microbiota, reducing endotoxemia and systemic inflammation. It lowers periodontal inflammation and prevents periodontal tissue degradation by improving immune response.

OBJECTIVE – To evaluate and compare the effectiveness of a novel prebiotic as an adjunct to SRP versus SRP alone on clinical periodontal parameters in individuals undergoing nonsurgical periodontal therapy.

**PRIMARY HYPOTHESIS-**There is a difference between the effectiveness of a novel prebiotic as an adjunct to SRP versus SRP alone in the nonsurgical treatment of Chronic Periodontitis.

**NULL HYPOTHESIS-**There is no difference between the effectiveness of a novel prebiotic as an adjunct to SRP versus SRP alone in the nonsurgical treatment of Chronic Periodontitis.

METHODOLOGY- The test group received 10mg inulin powder (5mg in the morning and 5 mg in the evening) mixed with water for 2 weeks before SRP and continued for 2 months, while the control group underwent SRP alone. Clinical parameters, Plaque index (PI), Gingival Index (GI), Bleeding on Probing (BOP), Pocket probing depth (PPD), Clinical Attachment Loss (CAL), were assessed at baseline, 1 month and 2 months.

研究设计

研究类型
Interventional
分配方式
Na
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • An individual who will be able to attend the examination for 10 weeks of study.
  • Pocket depth greater than or equal to 4mm bilaterally.

排除标准

  • History of Diabetes Chronic Gastrointestinal Conditions Current or previous use of antibiotics within the past 4 weeks Smokers Pregnant and lactating women.

结局指标

主要结局

Is there any beneficial effect in usage of a novel prebiotic as an adjunct to SRP in reducing the inflammation in chronic periodontitis compared to the SRP alone?

时间窗: The clinical periodontal parameters like plaque index PI gingival index GI Pocket depth PD and Clinical attachment loss CAL will be evaluated at Baseline, 4 weeks and 6 weeks

次要结局

未报告次要终点

研究者

发起方
Terna Dental College and Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Himani Jagtap

Terna Dental College

研究点 (1)

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