Role of Herbal Immunomodulators in the Treatment of Chronic Periodontitis

Chronic Periodontitis Clinical Trial

— Septilin  

Official title:

EFFECT OF SRP WITH ADJUNCTIVE THERAPY OF HERBAL IMMUNOMODULATORS ON THE SERUM C REACTIVE PROTEIN (CRP) LEVELS & CLINICAL PARAMETERS IN CHRONIC PERIODONTITIS PATIENTS - A RANDOMISED, DOUBLE BLIND, PLACEBO CONTROLLED, CLINICAL TRIAL.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01997814
• Other study ID #: TKDC12
• Status: Completed
• Phase: Phase 4
• First received: November 19, 2013
• Last updated: November 27, 2013
• Start date: March 2012
• Est. completion date: October 2013

Study information

• Verified date: November 2013
• Source: Tatyasaheb Kore Dental College
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

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

Locations

Country	Name	City	State
India	Tatyasaheb Kore Dental College and Research Centre, New Pargaon	Kolhapur	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Tatyasaheb Kore Dental College

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	baseline, 3 weeks, 6 weeks	No
Primary	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.	baseline, 3 weeks and 6 weeks	No
Primary	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.	baseline, 3 weeks and 6 weeks	No
Secondary	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.	baseline, 3 weeks and 6 weeks	No
Secondary	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.	baseline, 3 weeks and 6 weeks	No
Secondary	Changes from baseline in Oral Hygiene Index Simplified (OHIS) at 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.	baseline, 3 weeks and 6 weeks	No
Secondary	Changes from baseline in Sulcus Bleeding Index (SBI) at 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).	baseline, 3 weeks and 6 weeks	No