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

Phase 3

• Conditions: Periodontitis
• Interventions: Drug: 1 % curcumin chip; Other: Placebo chip; Procedure: Scaling and root planing

• Registration Number: NCT03790605
• Lead Sponsor: KLE Society's Institute of Dental Sciences

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-19
• Study First Submitted QC: 2018-12-28
• Study First Posted: 2018-12-31
• Study Start: 2019-09-04
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-12
• Last Update Posted: 2019-12-13
• Primary Completion: 2020-09-01
• Study Completion: 2020-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1% curcumin chip	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)
1% curcumin chip	Scaling and root planing	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)
Placebo chip	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)
Placebo chip	Scaling and root planing	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)

Primary Outcome Measures

Name	Time	Method
Cytokine parameter	Change from Baseline to 4 weeks	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

Name	Time	Method
Probing pocket depth	Changes from Baseline to 4 weeks and 12 weeks	Intragroup within each group (1- curcumin group and 2- placebo group) and intergroup comparison between the two groups
Clinical attachment level	Changes from Baseline to 4 weeks and 12 weeks	Intragroup within each group (1- curcumin group and 2- placebo group) and intergroup comparison between the two groups
Plaque index by Silness and Loe in 1964	Baseline from. 4 weeks, 12 weeks	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	Changes from Baseline to 4 weeks and 12 weeks	Intragroup within each group ( 1-curcumin group and 2- placebo group) and intergroup comparison between the two group

Trial Locations

Locations (1)

K L E society's Dental College; 🇮🇳 Bangalore, Karnataka, India