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

NCT02013323 | Completed Phase 2 DMC

• 1 other identifier: GDCRI/ACM/PG/PhD/10/2013-14
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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)

Conditions

Chronic Periodontitis

Keywords

Septiline, chronic periodontitis, Immunomodulator, microbiology

Outcome Measures

Primary Outcomes (1)

• Clinical Attachment Level (CAL)

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

  Gain in CAL from Baseline to 6 month

Secondary Outcomes (1)

• 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

Study Arms (2)

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

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

Placebo Group

PLACEBO COMPARATOR

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

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

Interventions

Scaling and root planing, and Septilin for 7 days DRUG

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.

Septilin Group

Scaling and root planing, and Placebo drug for 7 days DRUG

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

Placebo Group

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Government Dental College and Research Institute, Bangalore: lead
• Himalaya Drug Company Ltd. India: collaborator

Study Sites (1)

Government Dental College and Research Institute

Bangalore, Karnataka, 560002, India

Location

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Tooth Exfoliation; Root Planing; septilin

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Study Officials

• A R Pradeep, MDS

  Govt Dental College and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 8, 2013
• First Posted: December 17, 2013
• Study Start: March 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: December 17, 2013

Record last verified: 2013-12

Locations

IN (1)