Clinical and Microbiological Efficacy of Systemic Ayurvedic Immunomodulator Septilin in the Treatment of Chronic Periodontitis

Overview

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)

Full Title of Study: “Clinical and Microbiological Efficacy of Systemic Ayurvedic Immunomodulator Septilin in the Treatment of Chronic Periodontitis– A Randomized Controlled Clinical Trial.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 2013

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 (BL), 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.

Interventions

  • Drug: Scaling and root planing, and Septilin for 7 days
    • 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 and checked for clinical and micrbiological parameters at baseline, 10 days, 1 month, 3 months and 6 months.
  • Drug: Scaling and root planing, and Placebo drug for 7 days
    • Subjects in placebo group received placebo tablets taken thrice daily for 7 days and checked for clinical and microbiological parameters at baseline, 10 days, 1 month, 3 months and 6 months

Arms, Groups and Cohorts

  • Active Comparator: 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
  • Placebo Comparator: Placebo Group
    • Subjects in placebo group received Placebo tablets thrice daily for 7 days after Scaling and root planing

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • PIaque Index (PI), Gingival Index (GI), Probing Depth (PD), % Bleeding on Probing and reduction in number of sites positive for each microbial species
    • Time Frame: 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
    • 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 months

Participating in This Clinical Trial

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 – smokers – 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.

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Government Dental College and Research Institute, Bangalore
  • Collaborator
    • Himalaya Drug Company Ltd. India
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr. A R Pradeep, Professor – Government Dental College and Research Institute, Bangalore
  • Overall Official(s)
    • A R Pradeep, MDS, Principal Investigator, Govt Dental College and Research Institute

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