A Clinical Trial to Study the Effect of a Drug, Curcumin in Patients With Periodontitis

KLE Society's Institute of Dental Sciences40 enrolled

Overview

The study will follow a parallel arm, randomised, double blinded, placebo controlled design. There will be two groups Group 1 = receiving 1% curcumin chips after routine scaling and root planing (n=20) Group 2 = receiving placebo chips after routine scaling and root planing (n=20) Clinical parameters: ( Baseline, 4 weeks, 12 weeks) Probing pocket depth, clinical attachment level, gingival index, plaque index Cytokine parameter ( Baseline, 4 weeks) Interleukin 1 beta in GCF Statistical analysis Repeated measures of ANOVA Paired t-tests

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Periodontitis

Interventions

1 % curcumin chipDRUG

CURCUMIN CHIP: 4x5x0.5mm chip of 1% curcumin in biodegradable hydroxy propyl methyl cellulose vehicle

Placebo chipOTHER

PLACEBO CHIP: 4x5x0.5mm chip (identical to test chip except for the active therapeutic ingredient) in biodegradable hydroxy propyl methyl cellulose vehicle

Scaling and root planingPROCEDURE

Routine full mouth scaling and root planing within 48 hours will be performed at baseline prior to local placement of the chips

Eligibility

Sex: ALLMin age: 20 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Systemically healthy individuals 2. Presence of a minimum of 20 teeth in the oral cavity 3. Localised periodontal pockets with probing depths greater than 4mm i.e., Periodontitis in its stages 2 and 3, as described by the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions, and published by the American Academy of Periodontology (AAP) Exclusion Criteria: 1. Known allergy to curcumin and/ or hydroxyl propyl methyl cellulose 2. Systemic diseases and/or Inflammatory conditions, Obesity 3. Former or current tobacco users 4. Chronic consumption of alcohol 5. Use of anti-inflammatory drugs and antibiotics over the past 3 months 6. Periodontal therapy in any form, surgical or non surgical in the past 6 months 7. Pregnant and lactating mothers

Locations (1)

K L E society's Dental College

Bangalore, Karnataka, India

RECRUITING

Outcomes

Primary Outcomes

Cytokine parameter

Intragroup comparison within each group (1-curcumin group and 2- placebo group) and intergroup comparison between the two groups of levels of interleukin 1 beta in the gingival crevicular fluid quantified by ELISA in picogram per milliliter

Time frame: Change from Baseline to 4 weeks

Secondary Outcomes

Probing pocket depth

Intragroup within each group (1- curcumin group and 2- placebo group) and intergroup comparison between the two groups

Time frame: Changes from Baseline to 4 weeks and 12 weeks

Clinical attachment level

Intragroup within each group (1- curcumin group and 2- placebo group) and intergroup comparison between the two groups

Time frame: Changes from Baseline to 4 weeks and 12 weeks

Gingival Bleeding Index by Loe and Silness in 1963

Intragroup within each group ( 1-curcumin group and 2- placebo group) and intergroup comparison between the two group

Time frame: Changes from Baseline to 4 weeks and 12 weeks

Plaque index by Silness and Loe in 1964

Intragroup within each group ( 1- curcumin group and 2- placebo group) and intergroup comparison between the two groups

Time frame: Baseline from. 4 weeks, 12 weeks

Central Contacts

Riya A Daniel, BDS, PG student

CONTACT

9444140560 riyaad.rd@gmail.com

Data from ClinicalTrials.gov

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