Trial | NCT02013323  Report issue

Title

Clinical and Microbiological Efficacy of Systemic Ayurvedic Immunomodulator Septilin in the Treatment of Chronic Periodontitis
Clinical and Microbiological Efficacy of Systemic Ayurvedic Immunomodulator Septilin in the Treatment of Chronic Periodontitis-- A Randomized Controlled Clinical Trial.

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    septilin ...

  • Study Participants

    60
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)
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 Started
Mar 31
2013
Primary Completion
Aug 31
2013
Study Completion
Aug 31
2013
Last Update
Dec 17
2013
Estimate

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

Septilin Group Active Comparator

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 Group Placebo Comparator

Subjects in placebo group received Placebo tablets thrice daily for 7 days after Scaling and root planing

Criteria 

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.
No Results Posted