Clinical and Microbiological Efficacy of Systemic Ayurvedic Immunomodulator Septilin in the Treatment of Chronic Periodontitis
NCT ID: NCT02013323
Last Updated: 2013-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2013-03-31
2013-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Septilin Group
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
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.
Placebo Group
Subjects in placebo group received Placebo tablets thrice daily for 7 days after Scaling and root planing
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
Interventions
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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.
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
30 Years
50 Years
ALL
Yes
Sponsors
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Himalaya Drug Company Ltd. India
UNKNOWN
Government Dental College and Research Institute, Bangalore
OTHER
Responsible Party
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Dr. A R Pradeep
Professor
Principal Investigators
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A R Pradeep, MDS
Role: PRINCIPAL_INVESTIGATOR
Govt Dental College and Research Institute
Locations
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Government Dental College and Research Institute
Bangalore, Karnataka, India
Countries
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Other Identifiers
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GDCRI/ACM/PG/PhD/10/2013-14
Identifier Type: -
Identifier Source: org_study_id