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

Primary Purpose

Periodontitis

Status

Unknown status

Phase

Phase 3

Locations

India

Study Type

Interventional

Intervention

1 % curcumin chip

Placebo chip

Scaling and root planing

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring periodontitis, 1% curcumin chips, host modulation therapy, anti inflammatory effect, interleukin 1 beta

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Systemically healthy individuals
Presence of a minimum of 20 teeth in the oral cavity
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:

Known allergy to curcumin and/ or hydroxyl propyl methyl cellulose
Systemic diseases and/or Inflammatory conditions, Obesity
Former or current tobacco users
Chronic consumption of alcohol
Use of anti-inflammatory drugs and antibiotics over the past 3 months
Periodontal therapy in any form, surgical or non surgical in the past 6 months
Pregnant and lactating mothers

Sites / Locations

K L E society's Dental CollegeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1% curcumin chip

Placebo chip

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Probing pocket depth

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

Clinical attachment level

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

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

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

Full Information

NCT ID

NCT03790605

First Posted

December 19, 2018

Last Updated

December 12, 2019

Sponsor

KLE Society's Institute of Dental Sciences

1. Study Identification

Unique Protocol Identification Number

NCT03790605

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Unknown status

Study Start Date

September 4, 2019 (Actual)

Primary Completion Date

September 1, 2020 (Anticipated)

Study Completion Date

December 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

KLE Society's Institute of Dental Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Periodontitis

Keywords

periodontitis, 1% curcumin chips, host modulation therapy, anti inflammatory effect, interleukin 1 beta

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

Total subjects = 40 INCLUSION CRITERION Systemically healthy individuals both males and females of 20-60 years Presence of a minimum of 20 teeth in the oral cavity 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 CRITERION 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

Masking

ParticipantOutcomes Assessor

Masking Description

The study design follows a double blinded design where the participant and the outcome assessor are unaware of the intervention to the subject

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

1% curcumin chip

Arm Type

Experimental

Arm Description

Arm Title

Placebo chip

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

1 % curcumin chip

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Placebo chip

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Scaling and root planing

Intervention Description

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

Primary Outcome Measure Information:

Title

Cytokine parameter

Description

Time Frame

Change from Baseline to 4 weeks

Secondary Outcome Measure Information:

Title

Probing pocket depth

Description

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

Title

Clinical attachment level

Description

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

Title

Gingival Bleeding Index by Loe and Silness in 1963

Description

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

Title

Plaque index by Silness and Loe in 1964

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Systemically healthy individuals Presence of a minimum of 20 teeth in the oral cavity 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: Known allergy to curcumin and/ or hydroxyl propyl methyl cellulose Systemic diseases and/or Inflammatory conditions, Obesity Former or current tobacco users Chronic consumption of alcohol Use of anti-inflammatory drugs and antibiotics over the past 3 months Periodontal therapy in any form, surgical or non surgical in the past 6 months Pregnant and lactating mothers

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Riya A Daniel, BDS, PG student

Phone

9444140560

Ext

+91

riyaad.rd@gmail.com

Facility Information:

Facility Name

K L E society's Dental College

City

Bangalore

State/Province

Karnataka

ZIP/Postal Code

560022

Country

India

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Riya Daniel, BDS

Phone

9444140560

Ext

+91

riyaad.rd@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing 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

Learn more about this trial

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

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