Clinical and Microbiological Efficacy of Systemic Ayurvedic Immunomodulator Septilin in the Treatment of Chronic Periodontitis-- A Randomized Controlled Clinical Trial.
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Clinical Attachment Level (CAL)
Study Overview
Brief Summary
The present clinical trial was designed to investigate the clinical and microbiological effectiveness of systemic ayurvedic immunomodulator Septilin as an adjunct to scaling and root planing (SRP) in the treatment of chronic periodontitis (CP)
Detailed Description
OBJECTIVE
The present clinical trial was designed to investigate the clinical and microbiological effectiveness of systemic ayurvedic immunomodulator Septilin as an adjunct to scaling and root planing (SRP) in the treatment of chronic periodontitis (CP).
DESIGN: Sixty five subjects presenting at least twelve teeth with probing depth (PD) ≥4 mm were selected. 33 subjects were randomly assigned to full-mouth SRP + Septilin (group 1) and 32 subjects were assigned to full-mouth SRP + Placebo (group 2). The clinical outcomes evaluated were plaque index (PI), gingival index (GI), clinical attachment level (CAL), PD and % of sites with bleeding on probing (%BOP) at baseline (B\L), 10 days, 1, 3 and 6 months interval and percentage of sites positive for A. actinomycetemcomitans, P. gingivalis and T. forsythia were recorded at B/L, 3 and 6 months using polymerase chain reaction.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •age 30 to 50 years
- •atleast 12 scorable teeth with a probing depth (PD) ≥ 4 mm not including third molars
- •teeth with orthodontic appliances bridges, crowns, or implants
- •radiographic evidence of bone loss.
Exclusion Criteria
- •pregnancy or lactation
- •systemic diseases like diabetes mellitus, immunocompromised patients
- •systemic antibiotics taken within the previous 6 months
- •use of non-steroidal anti-inflammatory drugs
- •sub-gingival SRP or surgical periodontal therapy in the previous year.
Arms & Interventions
Septilin Group
Subjects in septilin group received Septilin tablets (Septilin tablets, Himalaya Drug Company, India), 500 mg of 2 tablets to be taken thrice daily for 7 days after scaling and root planing
Intervention: Scaling and root planing, and Septilin for 7 days (Drug)
Placebo Group
Subjects in placebo group received Placebo tablets thrice daily for 7 days after Scaling and root planing
Intervention: Scaling and root planing, and Placebo drug for 7 days (Drug)
Outcomes
Primary Outcomes
Clinical Attachment Level (CAL)
Time Frame: Gain in CAL from Baseline to 6 month
The primary outcome of the study was gain in CAL from Baseline to 6 month
Secondary Outcomes
- PIaque Index (PI), Gingival Index (GI), Probing Depth (PD), % Bleeding on Probing and reduction in number of sites positive for each microbial species(The differences in PI, GI, PD, %BOP between two groups and reduction in number of sites positive for each microbial species from Baseline to 6 month)
Investigators
Dr. A R Pradeep
Professor
Government Dental College and Research Institute, Bangalore