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

Periodontitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03790605
• Other study ID #: riya1curcumin
• Status: Recruiting
• Phase: Phase 3
• Start date: September 4, 2019
• Est. completion date: December 1, 2020

Study information

• Verified date: December 2019
• Source: KLE Society's Institute of Dental Sciences
• Contact: Riya A Daniel, BDS, PG student
• Phone: 9444140560
• Email: riyaad.rd[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 1, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Periodontitis

Intervention

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

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

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

Locations

Country	Name	City	State
India	K L E society's Dental College	Bangalore	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
KLE Society's Institute of Dental Sciences

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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