Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 24 of 157 for:    Enzyme | curcumin

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03790605
Recruitment Status : Not yet recruiting
First Posted : December 31, 2018
Last Update Posted : December 31, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Riya Achamma Daniel, 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


Condition or disease Intervention/treatment Phase
Periodontitis Drug: 1 % curcumin chip Other: Placebo chip Procedure: Scaling and root planing Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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

Masking: Double (Participant, Outcomes Assessor)
Masking Description: The study design follows a double blinded design where the participant and the outcome assessor are unaware of the intervention to the subject
Primary Purpose: Treatment
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
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Curcumin

Arm Intervention/treatment
Experimental: 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)
Drug: 1 % curcumin chip
CURCUMIN CHIP: 4x5x0.5mm chip of 1% curcumin 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

Placebo Comparator: 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)
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




Primary Outcome Measures :
  1. Cytokine parameter [ Time Frame: 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 :
  1. Probing pocket depth [ Time Frame: 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

  2. Clinical attachment level [ Time Frame: 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

  3. Gingival Bleeding Index by Loe and Silness in 1963 [ Time Frame: 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

  4. Plaque index by Silness and Loe in 1964 [ Time Frame: Baseline from. 4 weeks, 12 weeks ]
    Intragroup within each group ( 1- curcumin group and 2- placebo group) and intergroup comparison between the two groups



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03790605


Contacts
Layout table for location contacts
Contact: Riya A Daniel, BDS, PG student 9444140560 ext +91 riyaad.rd@gmail.com

Sponsors and Collaborators
KLE Society's Institute of Dental Sciences

Layout table for additonal information
Responsible Party: Dr. Riya Achamma Daniel, Post graduate student, Principal Investigator, Department of Periodontics, KLE Society's Institute of Dental Sciences, Bangalore, KLE Society's Institute of Dental Sciences
ClinicalTrials.gov Identifier: NCT03790605     History of Changes
Other Study ID Numbers: riya1curcumin
First Posted: December 31, 2018    Key Record Dates
Last Update Posted: December 31, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: For the purpose of confidentiality, as will be promised to the participants while signing the informed consent, all individual records except that of the parameters assessed during the study and the photographs taken will remain unshared to the public or fellow researchers

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Dr. Riya Achamma Daniel, KLE Society's Institute of Dental Sciences:
periodontitis, 1% curcumin chips, host modulation therapy, anti inflammatory effect, interleukin 1 beta
Additional relevant MeSH terms:
Layout table for MeSH terms
Enzyme Inhibitors
Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Curcumin
Iproplatin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action