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

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ClinicalTrials.gov Identifier: NCT01997814
Recruitment Status : Completed
First Posted : November 28, 2013
Last Update Posted : November 28, 2013
Sponsor:
Information provided by (Responsible Party):
GIRISH DEORE, 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.

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Drug: herbal immunomodulator Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : March 2012
Actual Primary Completion Date : July 2013
Actual Study Completion Date : October 2013

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 Name: 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.




Primary Outcome Measures :
  1. Change from baseline in serum CRP levels at 3 weeks and 6 weeks [ Time Frame: 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)

  2. changes from baseline in Pocket Depth (PD) at 3 weeks and 6 weeks. [ Time Frame: 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.

  3. changes from baseline in Clinical Attachment Level (CAL) at 3 weeks and 6 weeks. [ Time Frame: 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 :
  1. Changes from baseline in Gingival Index (GI) at 3 weeks and 6 weeks [ Time Frame: 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.

  2. change from baseline in Plaque Index (PI) at 3 weeks and 6 weeks [ Time Frame: 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.

  3. Changes from baseline in Oral Hygiene Index Simplified (OHIS) at 3 weeks and 6 weeks. [ Time Frame: 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.

  4. Changes from baseline in Sulcus Bleeding Index (SBI) at 3 weeks and 6 weeks [ Time Frame: 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).



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Ages Eligible for Study:   30 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01997814


Locations
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India
Tatyasaheb Kore Dental College and Research Centre, New Pargaon
Kolhapur, Maharashtra, India, 416137
Sponsors and Collaborators
Tatyasaheb Kore Dental College
Investigators
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Principal Investigator: Girish D Deore, BDS Post Graduate Student

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Responsible Party: GIRISH DEORE, Principal Investigator, Tatyasaheb Kore Dental College
ClinicalTrials.gov Identifier: NCT01997814     History of Changes
Other Study ID Numbers: TKDC12
First Posted: November 28, 2013    Key Record Dates
Last Update Posted: November 28, 2013
Last Verified: November 2013

Keywords provided by GIRISH DEORE, Tatyasaheb Kore Dental College:
Herbal medicine,
Host modulation therapy,
Periodontitis,
Meta-analysis,
Scaling and root planing.

Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Immunologic Factors
Adjuvants, Immunologic
Physiological Effects of Drugs