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

Phase 2

Completed

• Conditions: Chronic Periodontitis
• Interventions: Drug: Scaling and root planing, and Septilin for 7 days; Drug: Scaling and root planing, and Placebo drug for 7 days

• Registration Number: NCT02013323
• Lead Sponsor: Government Dental College and Research Institute, Bangalore

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 Timeline

• Study Start: 2013-03
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2013-12
• Study First Submitted: 2013-12-08
• Study First Submitted QC: 2013-12-11
• Last Update Submitted: 2013-12-11
• Study First Posted: 2013-12-17
• Last Update Posted: 2013-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Septilin Group	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
Placebo Group	Scaling and root planing, and Placebo drug for 7 days	Subjects in placebo group received Placebo tablets thrice daily for 7 days after Scaling and root planing

Primary Outcome Measures

Name	Time	Method
Clinical Attachment Level (CAL)	Gain in CAL from Baseline to 6 month	The primary outcome of the study was gain in CAL from Baseline to 6 month

Secondary Outcome Measures

Name	Time	Method
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	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

Trial Locations

Locations (1)

Government Dental College and Research Institute; 🇮🇳 Bangalore, Karnataka, India