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

Primary Purpose

Chronic Periodontitis

Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
herbal immunomodulator
Placebo
Sponsored by
Tatyasaheb Kore Dental College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis focused on measuring Herbal medicine,, Host modulation therapy,, Periodontitis,, Meta-analysis,, Scaling and root planing.

Eligibility Criteria

30 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Tatyasaheb Kore Dental College and Research Centre, New Pargaon

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Test Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)
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.
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.

Secondary Outcome Measures

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.
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.
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.
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).

Full Information

First Posted
November 19, 2013
Last Updated
November 27, 2013
Sponsor
Tatyasaheb Kore Dental College
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1. Study Identification

Unique Protocol Identification Number
NCT01997814
Brief Title
Role of Herbal Immunomodulators in the Treatment of Chronic Periodontitis
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tatyasaheb Kore Dental College

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis
Keywords
Herbal medicine,, Host modulation therapy,, Periodontitis,, Meta-analysis,, Scaling and root planing.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
herbal immunomodulator
Other Intervention Name(s)
Septilin (brand name)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients in Control Group were treated with scaling and root planing (SRP) along with Placebo therapy, 2 tablets twice daily for 3 weeks.
Primary Outcome Measure Information:
Title
Change from baseline in serum CRP levels at 3 weeks and 6 weeks
Description
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
Title
changes from baseline in Pocket Depth (PD) at 3 weeks and 6 weeks.
Description
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
Title
changes from baseline in Clinical Attachment Level (CAL) at 3 weeks and 6 weeks.
Description
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 Outcome Measure Information:
Title
Changes from baseline in Gingival Index (GI) at 3 weeks and 6 weeks
Description
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
Title
change from baseline in Plaque Index (PI) at 3 weeks and 6 weeks
Description
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.
Time Frame
baseline, 3 weeks and 6 weeks
Title
Changes from baseline in Oral Hygiene Index Simplified (OHIS) at 3 weeks and 6 weeks.
Description
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.
Time Frame
baseline, 3 weeks and 6 weeks
Title
Changes from baseline in Sulcus Bleeding Index (SBI) at 3 weeks and 6 weeks
Description
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).
Time Frame
baseline, 3 weeks and 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients within age group of 30 to 55 years. Systemically healthy individuals. Patients with chronic generalized periodontitis (moderate and severe) according to Center of Disease Control (CDC) working group, 2007 criteria Exclusion Criteria: 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), Smoking, Chronic alcoholics, Pregnancy or lactation, Use of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), steroids or antibiotics / antimicrobials within January 2012 to Jun 2013, Confirmed or suspected intolerance to herbal medicines, Periodontal therapy done within the january 2012 to Jun 2013.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Girish D Deore, BDS
Organizational Affiliation
Post Graduate Student
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tatyasaheb Kore Dental College and Research Centre, New Pargaon
City
Kolhapur
State/Province
Maharashtra
ZIP/Postal Code
416137
Country
India

12. IPD Sharing Statement

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Role of Herbal Immunomodulators in the Treatment of Chronic Periodontitis

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