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

NCT03790605 | Unknown Phase 3 DMC

• 1 other identifier: riya1curcumin
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Periodontitis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Probing pocket depth

  Changes from Baseline to 4 weeks and 12 weeks

• Clinical attachment level

  Changes from Baseline to 4 weeks and 12 weeks

• Gingival Bleeding Index by Loe and Silness in 1963

  Changes from Baseline to 4 weeks and 12 weeks

• Plaque index by Silness and Loe in 1964

  Baseline from. 4 weeks, 12 weeks

Study Arms (2)

1% curcumin chip

EXPERIMENTAL

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; Procedure: Scaling and root planing

Placebo chip

PLACEBO COMPARATOR

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)

Other: Placebo chip; Procedure: Scaling and root planing

Interventions

1 % curcumin chip DRUG

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

1% curcumin chip

Placebo chip OTHER

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

Placebo chip

Scaling and root planing PROCEDURE

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

1% curcumin chip; Placebo chip

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• KLE Society's Institute of Dental Sciences: lead

Study Sites (1)

K L E society's Dental College

Bangalore, Karnataka, 560022, India

RECRUITING

MeSH Terms

Conditions

Periodontitis

Interventions

Tooth Exfoliation; Root Planing

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Central Study Contacts

Riya A Daniel, BDS, PG student

CONTACT

9444140560; riyaad.rd@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The study design follows a double blinded design where the participant and the outcome assessor are unaware of the intervention to the subject
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post graduate student, Principal Investigator, Department of Periodontics, KLE Society's Institute of Dental Sciences, Bangalore

Model Details: Total subjects = 40 INCLUSION CRITERION 1. Systemically healthy individuals both males and females of 20-60 years 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 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

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: December 31, 2018
• Study Start: September 4, 2019
• Primary Completion: September 1, 2020
• Study Completion: December 1, 2020
• Last Updated: December 13, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)