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

Phase 2CompletedNCT02013323

Government Dental College and Research Institute, Bangalore60 enrolled

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)

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Chronic Periodontitis

Interventions

Scaling and root planing, and Septilin for 7 daysDRUG

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.

Scaling and root planing, and Placebo drug for 7 daysDRUG

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

Eligibility

Sex: ALLMin age: 30 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Government Dental College and Research Institute

Bangalore, Karnataka, India

Outcomes

Primary Outcomes

Clinical Attachment Level (CAL)

The primary outcome of the study was gain in CAL from Baseline to 6 month

Time frame: 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 months

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

Data from ClinicalTrials.gov

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