Skip to main content
OpenTrials
Completed

NCT Number: NCT01997814

Role of Herbal Immunomodulators in the Treatment of Chronic Periodontitis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Periodontitis Chronic Disease Disease Attributes Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

30 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tatyasaheb Kore Dental College and Research Centre, New Pargaon

Kolhāpur, Maharashtra, 416137, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

herbal immunomodulator

Drug

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

Drug

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

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Tatyasaheb Kore Dental College

Other

Registry information

Official study 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.

Acronym: Septilin

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 28, 2013
Registry last updated
Nov 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.