Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2026-03-12 @ 12:12 AM
Study NCT ID:
NCT03790605
Status:
UNKNOWN
Last Update Posted:
2019-12-13
First Post:
2018-12-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial to Study the Effect of a Drug, Curcumin in Patients With Periodontitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010518', 'term': 'Periodontitis'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014080', 'term': 'Tooth Exfoliation'}, {'id': 'D016745', 'term': 'Root Planing'}], 'ancestors': [{'id': 'D009063', 'term': 'Dental Physiological Phenomena'}, {'id': 'D055688', 'term': 'Digestive System and Oral Physiological Phenomena'}, {'id': 'D012534', 'term': 'Dental Scaling'}, {'id': 'D003777', 'term': 'Dental Prophylaxis'}, {'id': 'D010517', 'term': 'Periodontics'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D013357', 'term': 'Subgingival Curettage'}, {'id': 'D011313', 'term': 'Preventive Dentistry'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The study design follows a double blinded design where the participant and the outcome assessor are unaware of the intervention to the subject'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Total subjects = 40 INCLUSION CRITERION\n\n1. Systemically healthy individuals both males and females of 20-60 years\n2. Presence of a minimum of 20 teeth in the oral cavity\n3. 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\n\n1 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'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-09-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2020-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-12-12', 'studyFirstSubmitDate': '2018-12-19', 'studyFirstSubmitQcDate': '2018-12-28', 'lastUpdatePostDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cytokine parameter', 'timeFrame': 'Change from Baseline to 4 weeks', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Probing pocket depth', 'timeFrame': 'Changes from Baseline to 4 weeks and 12 weeks', 'description': 'Intragroup within each group (1- curcumin group and 2- placebo group) and intergroup comparison between the two groups'}, {'measure': 'Clinical attachment level', 'timeFrame': 'Changes from Baseline to 4 weeks and 12 weeks', 'description': 'Intragroup within each group (1- curcumin group and 2- placebo group) and intergroup comparison between the two groups'}, {'measure': 'Gingival Bleeding Index by Loe and Silness in 1963', 'timeFrame': 'Changes from Baseline to 4 weeks and 12 weeks', 'description': 'Intragroup within each group ( 1-curcumin group and 2- placebo group) and intergroup comparison between the two group'}, {'measure': 'Plaque index by Silness and Loe in 1964', 'timeFrame': 'Baseline from. 4 weeks, 12 weeks', 'description': 'Intragroup within each group ( 1- curcumin group and 2- placebo group) and intergroup comparison between the two groups'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['periodontitis, 1% curcumin chips, host modulation therapy, anti inflammatory effect, interleukin 1 beta'], 'conditions': ['Periodontitis']}, 'descriptionModule': {'briefSummary': 'The study will follow a parallel arm, randomised, double blinded, placebo controlled design.\n\nThere 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\n\nStatistical analysis Repeated measures of ANOVA Paired t-tests'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Systemically healthy individuals\n2. Presence of a minimum of 20 teeth in the oral cavity\n3. 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)\n\nExclusion Criteria:\n\n1. Known allergy to curcumin and/ or hydroxyl propyl methyl cellulose\n2. Systemic diseases and/or Inflammatory conditions, Obesity\n3. Former or current tobacco users\n4. Chronic consumption of alcohol\n5. Use of anti-inflammatory drugs and antibiotics over the past 3 months\n6. Periodontal therapy in any form, surgical or non surgical in the past 6 months\n7. Pregnant and lactating mothers'}, 'identificationModule': {'nctId': 'NCT03790605', 'briefTitle': 'A Clinical Trial to Study the Effect of a Drug, Curcumin in Patients With Periodontitis', 'organization': {'class': 'OTHER', 'fullName': "KLE Society's Institute of Dental Sciences"}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'riya1curcumin'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1% curcumin chip', 'description': '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)', 'interventionNames': ['Drug: 1 % curcumin chip', 'Procedure: Scaling and root planing']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo chip', 'description': '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)', 'interventionNames': ['Other: Placebo chip', 'Procedure: Scaling and root planing']}], 'interventions': [{'name': '1 % curcumin chip', 'type': 'DRUG', 'description': 'CURCUMIN CHIP: 4x5x0.5mm chip of 1% curcumin in biodegradable hydroxy propyl methyl cellulose vehicle', 'armGroupLabels': ['1% curcumin chip']}, {'name': 'Placebo chip', 'type': 'OTHER', 'description': 'PLACEBO CHIP: 4x5x0.5mm chip (identical to test chip except for the active therapeutic ingredient) in biodegradable hydroxy propyl methyl cellulose vehicle', 'armGroupLabels': ['Placebo chip']}, {'name': 'Scaling and root planing', 'type': 'PROCEDURE', 'description': 'Routine full mouth scaling and root planing within 48 hours will be performed at baseline prior to local placement of the chips', 'armGroupLabels': ['1% curcumin chip', 'Placebo chip']}]}, 'contactsLocationsModule': {'locations': [{'zip': '560022', 'city': 'Bangalore', 'state': 'Karnataka', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Riya Daniel, BDS', 'role': 'CONTACT', 'email': 'riyaad.rd@gmail.com', 'phone': '9444140560', 'phoneExt': '+91'}], 'facility': "K L E society's Dental College", 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}], 'centralContacts': [{'name': 'Riya A Daniel, BDS, PG student', 'role': 'CONTACT', 'email': 'riyaad.rd@gmail.com', 'phone': '9444140560', 'phoneExt': '+91'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', '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'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "KLE Society's Institute of Dental Sciences", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Post graduate student, Principal Investigator, Department of Periodontics, KLE Society's Institute of Dental Sciences, Bangalore", 'investigatorFullName': 'Dr. Riya Achamma Daniel', 'investigatorAffiliation': "KLE Society's Institute of Dental Sciences"}}}}