Role of Herbal Immunomodulators in the Treatment of Chronic Periodontitis

NCT01997814 | Completed Phase 4

• 1 other identifier: TKDC12
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Periodontitis

Keywords

Herbal medicine,; Host modulation therapy,; Periodontitis,; Meta-analysis,; Scaling and root planing.

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Changes from baseline in Gingival Index (GI) at 3 weeks and 6 weeks

  baseline, 3 weeks and 6 weeks

• change from baseline in Plaque Index (PI) at 3 weeks and 6 weeks

  baseline, 3 weeks and 6 weeks

• 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 Sulcus Bleeding Index (SBI) at 3 weeks and 6 weeks

  baseline, 3 weeks and 6 weeks

Study Arms (2)

Test Group

ACTIVE COMPARATOR

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

Control Group

PLACEBO COMPARATOR

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

Interventions

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.

Also known as: Septilin (brand name)

Test Group

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.

Control Group

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tatyasaheb Kore Dental College: lead

Study Sites (1)

Tatyasaheb Kore Dental College and Research Centre, New Pargaon

Kolhāpur, Maharashtra, 416137, India

Location

MeSH Terms

Conditions

Chronic Periodontitis; Periodontitis

Interventions

septilin

Condition Hierarchy (Ancestors)

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

Study Officials

• Girish D Deore, BDS

  Post Graduate Student

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 19, 2013
• First Posted: November 28, 2013
• Study Start: March 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: October 1, 2013
• Last Updated: November 28, 2013

Record last verified: 2013-11

Locations

IN (1)