Role of Herbal Immunomodulators in the Treatment of Chronic Periodontitis

Phase 4CompletedNCT01997814

Tatyasaheb Kore Dental College60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Chronic Periodontitis

Interventions

herbal immunomodulatorDRUG

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.

PlaceboDRUG

Patients in Control Group were treated with scaling and root planing (SRP) along with Placebo therapy, 2 tablets twice daily for 3 weeks.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Tatyasaheb Kore Dental College and Research Centre, New Pargaon

Kolhāpur, Maharashtra, India

Outcomes

Primary Outcomes

Change from baseline in serum CRP levels at 3 weeks and 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)

Time frame: baseline, 3 weeks, 6 weeks

changes from baseline in Pocket Depth (PD) at 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.

Time frame: baseline, 3 weeks and 6 weeks

changes from baseline in Clinical Attachment Level (CAL) at 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.

Time frame: baseline, 3 weeks and 6 weeks

Secondary Outcomes

Changes from baseline in Gingival Index (GI) at 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.

Time frame: baseline, 3 weeks and 6 weeks

change from baseline in Plaque Index (PI) at 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.

Data from ClinicalTrials.gov

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