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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Periodontitis

Intervention / Treatment
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* Drug: 1 % curcumin chip
* Other: Placebo chip
* Procedure: Scaling and root planing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1% curcumin chip<br>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<br>* CURCUMIN CHIP: 4x5x0.5mm chip of 1% curcumin in biodegradable hydroxy propyl methyl cellulose vehicle<br>Procedure: Scaling and root planing<br>* Routine full mouth scaling and root planing within 48 hours will be performed at baseline prior to local placement of the chips<br>|
| Placebo Comparator: Placebo chip<br>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<br>* PLACEBO CHIP: 4x5x0.5mm chip (identical to test chip except for the active therapeutic ingredient) in biodegradable hydroxy propyl methyl cellulose vehicle<br>Procedure: Scaling and root planing<br>* Routine full mouth scaling and root planing within 48 hours will be performed at baseline prior to local placement of the chips<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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periodontitis, 1% curcumin chips, host modulation therapy, anti inflammatory effect, interleukin 1 beta