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

Government Dental College and Research Institute, Bangalore

Status and phase: Completed; Phase 2

Conditions: Chronic Periodontitis

Treatments: Drug: Scaling and root planing, and Placebo drug for 7 days; Drug: Scaling and root planing, and Septilin for 7 days

Study type: Interventional

Funder types: Other

Identifiers

NCT02013323

GDCRI/ACM/PG/PhD/10/2013-14

Details and patient eligibility

About

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 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.

Enrollment: 60 patients

Sex: All

Ages: 30 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Septilin Group

Active Comparator group

Description:

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

Treatment:

Drug: Scaling and root planing, and Septilin for 7 days

Placebo Group

Placebo Comparator group

Description:

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

Treatment:

Drug: Scaling and root planing, and Placebo drug for 7 days