Chronic Periodontitis
Conditions
Keywords
Herbal medicine,, Host modulation therapy,, Periodontitis,, Meta-analysis,, Scaling and root planing.
Brief summary
Addition of systemic herbal immunomodulators with scaling & root planing (SRP) may enhance the therapeutic result of Chronic Periodontitis owing to host modulation & anti-inflammatory properties. If proven, herbal immunomodulators can be used as an adjunct to SRP.
Interventions
DRUGherbal immunomodulator
Patients in Test Group were treated with scaling and root planing (SRP) along with Herbal Immunomodulators (Septilin) therapy, 2 tablets twice daily for 3 weeks.
DRUGPlacebo
Patients in Control Group were treated with scaling and root planing (SRP) along with Placebo therapy, 2 tablets twice daily for 3 weeks.
Sponsors
Tatyasaheb Kore Dental College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Patients within age group of 30 to 55 years. 2. Systemically healthy individuals. 3. Patients with chronic generalized periodontitis (moderate and severe) according to Center of Disease Control (CDC) working group, 2007 criteria
Exclusion criteria
1. Patients with systemic illnesses (i.e., diabetes mellitus, cancer, human immunodeficiency syndrome, bone metabolic diseases, or disorders that compromise wound healing, radiation, or immunosuppressive therapy), 2. Smoking, 3. Chronic alcoholics, 4. Pregnancy or lactation, 5. Use of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), steroids or antibiotics / antimicrobials within January 2012 to Jun 2013, 6. Confirmed or suspected intolerance to herbal medicines, 7. Periodontal therapy done within the january 2012 to Jun 2013.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in serum CRP levels at 3 weeks and 6 weeks | baseline, 3 weeks, 6 weeks | changes from baseline in biochemical parameter, serum CRP levels were assessed at 3 weeks after starting therapy with herbal immunomodulators, then therapy was stopped and same changes were again assessed at 6 weeks from baseline. Serum CRP level was measured in milligram/liter (mg/l) |
| changes from baseline in Pocket Depth (PD) at 3 weeks and 6 weeks. | baseline, 3 weeks and 6 weeks | changes from baseline in standard clinical parameter, PD were assessed at 3 weeks after starting therapy with herbal immunomodulators, then therapy was stopped and same changes were again assessed at 6 weeks from baseline. PD was measured in millimeters. |
| changes from baseline in Clinical Attachment Level (CAL) at 3 weeks and 6 weeks. | baseline, 3 weeks and 6 weeks | changes from baseline in standard clinical parameter, CAL were assessed at 3 weeks after starting therapy with herbal immunomodulators, then therapy was stopped and same changes were again assessed at 6 weeks from baseline. PD was measured in millimeters. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline in Gingival Index (GI) at 3 weeks and 6 weeks | baseline, 3 weeks and 6 weeks | changes from baseline in standard clinical parameter, GI were assessed at 3 weeks after starting therapy with herbal immunomodulators, then therapy was stopped and same changes were again assessed at 6 weeks from baseline. GI has a scoring criteria specified by Silness & Loe, 1963. |
| Changes from baseline in Sulcus Bleeding Index (SBI) at 3 weeks and 6 weeks | baseline, 3 weeks and 6 weeks | changes from baseline in standard clinical parameter, SBI were assessed at 3 weeks after starting therapy with herbal immunomodulators, then therapy was stopped and same changes were again assessed at 6 weeks from baseline. SBI has a scoring criteria specified by Muhleman's (1971). |
| change from baseline in Plaque Index (PI) at 3 weeks and 6 weeks | baseline, 3 weeks and 6 weeks | changes from baseline in standard clinical parameter, PI were assessed at 3 weeks after starting therapy with herbal immunomodulators, then therapy was stopped and same changes were again assessed at 6 weeks from baseline. PI has a scoring criteria specified by Loe & Silness, 1964. |
| Changes from baseline in Oral Hygiene Index Simplified (OHIS) at 3 weeks and 6 weeks. | baseline, 3 weeks and 6 weeks | changes from baseline in standard clinical parameter, OHIS were assessed at 3 weeks after starting therapy with herbal immunomodulators, then therapy was stopped and same changes were again assessed at 6 weeks from baseline. OHIS has a scoring criteria specified by Greene and Vermilion, 1964. |
Countries
India
Outcome results
None listed