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.
Overview
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Terna Dental College and Hospital
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- 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?
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •An individual who will be able to attend the examination for 10 weeks of study.
- •Pocket depth greater than or equal to 4mm bilaterally.
Exclusion Criteria
- •History of Diabetes Chronic Gastrointestinal Conditions Current or previous use of antibiotics within the past 4 weeks Smokers Pregnant and lactating women.
Outcomes
Primary Outcomes
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?
Time Frame: 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
Secondary Outcomes
No secondary outcomes reported
Investigators
Himani Jagtap
Terna Dental College