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NCT Number: NCT02013323

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

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)

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Key information

Conditions

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

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Government Dental College and Research Institute

Bangalore, Karnataka, 560002, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

Primary outcomes

  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 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

    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

Sponsors and collaborators

Lead sponsor

Government Dental College and Research Institute, Bangalore

Other

Collaborators

  • Himalaya Drug Company Ltd. India

Registry information

Official study title

Clinical and Microbiological Efficacy of Systemic Ayurvedic Immunomodulator Septilin in the Treatment of Chronic Periodontitis-- A Randomized Controlled Clinical Trial.

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Dec 17, 2013
Registry last updated
Dec 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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