Chronic Periodontitis
Conditions
Keywords
Septiline, chronic periodontitis, Immunomodulator, microbiology
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.
Interventions
DRUGScaling 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.
DRUGScaling 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
Sponsors
Himalaya Drug Company Ltd. India
Government Dental College and Research Institute, Bangalore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Attachment Level (CAL) | Gain in CAL from Baseline to 6 month | The primary outcome of the study was gain in CAL from Baseline to 6 month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
Countries
India
Outcome results
None listed