Role of Herbal Immunomodulators in the Treatment of Chronic Periodontitis (Septilin)

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.

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 Overview

• Status: Completed
• Conditions: Chronic Periodontitis
• Intervention / Treatment: Drug: herbal immunomodulator; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Maharashtra
    • Kolhapur, Maharashtra, India, 416137
      • Tatyasaheb Kore Dental College and Research Centre, New Pargaon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Test Group; Patients in Test Group were given Herbal Immunomodulators (SeptilinTM) 2 tablets twice daily for 3 weeks then medications were stopped and changes in all parameters were again checked after 6 weeks.	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.; Other Names: Septilin (brand name)
PLACEBO_COMPARATOR: Control Group; Patients in Control Group were given placebo drug 2 tablets twice daily for 3 weeks then medications were stopped and changes in all parameters were again checked after 6 weeks.	Drug: Placebo; Patients in Control Group were treated with scaling and root planing (SRP) along with Placebo therapy, 2 tablets twice daily for 3 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Tatyasaheb Kore Dental College

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (ACTUAL): July 1, 2013
• Study Completion (ACTUAL): October 1, 2013

Study Registration Dates

• First Submitted: November 19, 2013
• First Submitted That Met QC Criteria: November 27, 2013
• First Posted (ESTIMATE): November 28, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): November 28, 2013
• Last Update Submitted That Met QC Criteria: November 27, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Periodontitis,; Herbal medicine,; Host modulation therapy,; Meta-analysis,; Scaling and root planing.
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis; Physiological Effects of Drugs; Immunologic Factors; Adjuvants, Immunologic
• Other Study ID Numbers: TKDC12