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

Tatyasaheb Kore Dental College

Status and phase: Completed; Phase 4

Conditions: Chronic Periodontitis

Treatments: Drug: herbal immunomodulator; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01997814

TKDC12

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 30 to 55 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

Test Group

Active Comparator group

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.

Treatment:

Drug: herbal immunomodulator

Control Group

Placebo Comparator group

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.

Treatment:

Drug: Placebo