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

Evaluation of the Host Modulating Effects of 1% Curcumin Chips as an Adjunct to Non Surgical Mechanical Debridement in the Treatment of Periodontitis: A Randomised Controlled Clinical Trial

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 Overview

• Status: Unknown
• Conditions: Periodontitis
• Intervention / Treatment: Drug: 1 % curcumin chip; Procedure: Scaling and root planing; Other: Placebo chip

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Riya A Daniel, BDS, PG student; Phone Number: +91 9444140560; Email: riyaad.rd@gmail.com

Study Locations

• India
  • Karnataka
    • Bangalore, Karnataka, India, 560022
      • Recruiting
      • K L E society's Dental College
      • Contact: Riya Daniel, BDS; Phone Number: +91 9444140560; Email: riyaad.rd@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1% curcumin chip; Following routine full mouth scaling and root planing within 48 hours, a single chip of 1% curcumin will be placed locally within a single isolated periodontal pocket(the deepest pocket in a patient will be chosen) using a forceps. The patient will be recalled after two weeks for the placement of another chip(second placement)	Drug: 1 % curcumin chip; CURCUMIN CHIP: 4x5x0.5mm chip of 1% curcumin in biodegradable hydroxy propyl methyl cellulose vehicle; Procedure: Scaling and root planing; Routine full mouth scaling and root planing within 48 hours will be performed at baseline prior to local placement of the chips
Placebo Comparator: Placebo chip; Following routine full mouth scaling and root planing within 48 hours, a single placebo chip will be placed locally within a single isolated periodontal pocket (the deepest pocket in a patient will be chosen) using a forceps. The patient will be recalled after two weeks for the placement of another chip (second placement)	Procedure: Scaling and root planing; Routine full mouth scaling and root planing within 48 hours will be performed at baseline prior to local placement of the chips; Other: Placebo chip; PLACEBO CHIP: 4x5x0.5mm chip (identical to test chip except for the active therapeutic ingredient) in biodegradable hydroxy propyl methyl cellulose vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Change from Baseline to 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probing pocket depth	Intragroup within each group (1- curcumin group and 2- placebo group) and intergroup comparison between the two groups	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	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	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	Baseline from. 4 weeks, 12 weeks

Collaborators and Investigators

• Sponsor: KLE Society's Institute of Dental Sciences

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2019
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: December 19, 2018
• First Submitted That Met QC Criteria: December 28, 2018
• First Posted (Actual): December 31, 2018

Study Record Updates

• Last Update Posted (Actual): December 13, 2019
• Last Update Submitted That Met QC Criteria: December 12, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: periodontitis, 1% curcumin chips, host modulation therapy, anti inflammatory effect, interleukin 1 beta
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Curcumin; Iproplatin
• Other Study ID Numbers: riya1curcumin

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: For the purpose of confidentiality, as will be promised to the participants while signing the informed consent, all individual records except that of the parameters assessed during the study and the photographs taken will remain unshared to the public or fellow researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No