Role of Herbal Immunomodulators in the Treatment of Chronic Periodontitis

Phase 4

Completed

• Conditions: Chronic Periodontitis
• Interventions: Drug: herbal immunomodulator; Drug: Placebo

• Registration Number: NCT01997814
• Lead Sponsor: Tatyasaheb Kore Dental College

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2013-07
• Study Completion: 2013-10
• Status Verified: 2013-11
• Study First Submitted: 2013-11-19
• Study First Submitted QC: 2013-11-27
• Last Update Submitted: 2013-11-27
• Study First Posted: 2013-11-28
• Last Update Posted: 2013-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test Group	herbal immunomodulator	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.
Control Group	Placebo	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.

Primary Outcome Measures

Name	Time	Method
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.
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 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 Outcome Measures

Name	Time	Method
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).
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.
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.

Trial Locations

Locations (1)

Tatyasaheb Kore Dental College and Research Centre, New Pargaon; 🇮🇳 Kolhapur, Maharashtra, India