Clinical trial NCT02013323: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Periodontitis
Keywords: Septiline, chronic periodontitis, Immunomodulator, microbiology
Lead sponsor: Government Dental College and Research Institute, Bangalore
Sponsor class: OTHER
Collaborators: name: Himalaya Drug Company Ltd. India
First posted: 2013-12-17
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Clinical Attachment Level (CAL)
timeFrame: Gain in CAL from Baseline to 6 month
Secondary outcomes:
measure: PIaque Index (PI), Gingival Index (GI), Probing Depth (PD), % Bleeding on Probing and reduction in number of sites positive for each microbial species
timeFrame: 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
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Government Dental College and Research Institute
state: Karnataka
Study officials:
affiliation: Govt Dental College and Research Institute
name: A R Pradeep, MDS
role: PRINCIPAL_INVESTIGATOR
References: