Clinical and Microbiological Efficacy of Systemic Ayurvedic Immunomodulator Septilin in the Treatment of Chronic Periodontitis
Primary Purpose
Chronic Periodontitis
Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
Scaling and root planing, and Septilin for 7 days
Scaling and root planing, and Placebo drug for 7 days
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Periodontitis focused on measuring Septiline, chronic periodontitis, Immunomodulator, microbiology
Eligibility Criteria
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.
Sites / Locations
- Government Dental College and Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Septilin Group
Placebo Group
Arm 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
Subjects in placebo group received Placebo tablets thrice daily for 7 days after Scaling and root planing
Outcomes
Primary Outcome Measures
Clinical Attachment Level (CAL)
The primary outcome of the study was gain in CAL from Baseline to 6 month
Secondary Outcome Measures
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
Full Information
NCT ID
NCT02013323
First Posted
December 8, 2013
Last Updated
December 11, 2013
Sponsor
Government Dental College and Research Institute, Bangalore
Collaborators
Himalaya Drug Company Ltd. India
1. Study Identification
Unique Protocol Identification Number
NCT02013323
Brief Title
Clinical and Microbiological Efficacy of Systemic Ayurvedic Immunomodulator Septilin in the Treatment of Chronic Periodontitis
Official Title
Clinical and Microbiological Efficacy of Systemic Ayurvedic Immunomodulator Septilin in the Treatment of Chronic Periodontitis-- A Randomized Controlled Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Government Dental College and Research Institute, Bangalore
Collaborators
Himalaya Drug Company Ltd. India
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis
Keywords
Septiline, chronic periodontitis, Immunomodulator, microbiology
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Septilin Group
Arm Type
Active Comparator
Arm 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
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Subjects in placebo group received Placebo tablets thrice daily for 7 days after Scaling and root planing
Intervention Type
Drug
Intervention Name(s)
Scaling and root planing, and Septilin for 7 days
Intervention 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 and checked for clinical and micrbiological parameters at baseline, 10 days, 1 month, 3 months and 6 months.
Intervention Type
Drug
Intervention Name(s)
Scaling and root planing, and Placebo drug for 7 days
Intervention Description
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
Primary Outcome Measure Information:
Title
Clinical Attachment Level (CAL)
Description
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 Outcome Measure Information:
Title
PIaque Index (PI), Gingival Index (GI), Probing Depth (PD), % Bleeding on Probing and reduction in number of sites positive for each microbial species
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
A R Pradeep, MDS
Organizational Affiliation
Govt Dental College and Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Government Dental College and Research Institute
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560002
Country
India
12. IPD Sharing Statement
Learn more about this trial
Clinical and Microbiological Efficacy of Systemic Ayurvedic Immunomodulator Septilin in the Treatment of Chronic Periodontitis
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