A Clinical Trial to Study the Effect of a Drug, Curcumin in Patients With Periodontitis
NCT ID: NCT03790605
Last Updated: 2019-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
40 participants
INTERVENTIONAL
2019-09-04
2020-12-01
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
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
TREATMENT
DOUBLE
Study Groups
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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
CURCUMIN CHIP: 4x5x0.5mm chip of 1% curcumin in biodegradable hydroxy propyl methyl cellulose vehicle
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
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
PLACEBO CHIP: 4x5x0.5mm chip (identical to test chip except for the active therapeutic ingredient) in biodegradable hydroxy propyl methyl cellulose vehicle
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
Interventions
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1 % curcumin chip
CURCUMIN CHIP: 4x5x0.5mm chip of 1% curcumin in biodegradable hydroxy propyl methyl cellulose vehicle
Placebo chip
PLACEBO CHIP: 4x5x0.5mm chip (identical to test chip except for the active therapeutic ingredient) in biodegradable hydroxy propyl methyl cellulose vehicle
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
Eligibility Criteria
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Inclusion Criteria
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
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
20 Years
60 Years
ALL
Yes
Sponsors
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KLE Society's Institute of Dental Sciences
OTHER
Responsible Party
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Dr. Riya Achamma Daniel
Post graduate student, Principal Investigator, Department of Periodontics, KLE Society's Institute of Dental Sciences, Bangalore
Locations
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K L E society's Dental College
Bangalore, Karnataka, India
Countries
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Central Contacts
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Facility Contacts
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Riya Daniel, BDS
Role: primary
Other Identifiers
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riya1curcumin
Identifier Type: -
Identifier Source: org_study_id