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Trial record 5 of 312 for:    "Periodontitis, Chronic"

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

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ClinicalTrials.gov Identifier: NCT02013323
Recruitment Status : Completed
First Posted : December 17, 2013
Last Update Posted : December 17, 2013
Sponsor:
Collaborator:
Himalaya Drug Company Ltd. India
Information provided by (Responsible Party):
Dr. A R Pradeep, 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)

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Drug: Scaling and root planing, and Septilin for 7 days Drug: Scaling and root planing, and Placebo drug for 7 days Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical and Microbiological Efficacy of Systemic Ayurvedic Immunomodulator Septilin in the Treatment of Chronic Periodontitis-- A Randomized Controlled Clinical Trial.
Study Start Date : March 2013
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Arm Intervention/treatment
Active Comparator: 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
Drug: 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 Comparator: Placebo Group
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
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 Measures :
  1. Clinical Attachment Level (CAL) [ Time Frame: 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 :
  1. PIaque Index (PI), Gingival Index (GI), Probing Depth (PD), % Bleeding on Probing and reduction in number of sites positive for each microbial species [ 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 ]
    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



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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02013323


Locations
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India
Government Dental College and Research Institute
Bangalore, Karnataka, India, 560002
Sponsors and Collaborators
Government Dental College and Research Institute, Bangalore
Himalaya Drug Company Ltd. India
Investigators
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Principal Investigator: A R Pradeep, MDS Govt Dental College and Research Institute

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Responsible Party: Dr. A R Pradeep, Professor, Government Dental College and Research Institute, Bangalore
ClinicalTrials.gov Identifier: NCT02013323     History of Changes
Other Study ID Numbers: GDCRI/ACM/PG/PhD/10/2013-14
First Posted: December 17, 2013    Key Record Dates
Last Update Posted: December 17, 2013
Last Verified: December 2013

Keywords provided by Dr. A R Pradeep, Government Dental College and Research Institute, Bangalore:
Septiline, chronic periodontitis, Immunomodulator, microbiology

Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Immunologic Factors
Adjuvants, Immunologic
Physiological Effects of Drugs