Ignite Creation Date:
2025-12-24 @ 3:03 PM
Ignite Modification Date:
2026-02-06 @ 9:14 PM
Study NCT ID:
NCT06505759
Status:
RECRUITING
Last Update Posted:
2025-01-13
First Post:
2024-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of 2%Bromelain Gel With 0.2%CHX Gel as Subgingival LDD Following SRP in Stage II/III and Grade B Periodontitis -A RCT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010514', 'term': 'Periodontal Pocket'}], 'ancestors': [{'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-09', 'studyFirstSubmitDate': '2024-07-11', 'studyFirstSubmitQcDate': '2024-07-11', 'lastUpdatePostDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Probing pocket Depth (PPD)', 'timeFrame': '3 months', 'description': 'measured using a UNC-15 probe (university of North Carolina-15 periodontal probe- Hu-Friedy, Chicago, IL, USA'}, {'measure': 'Relative attachment level (RAL)', 'timeFrame': '3 months', 'description': '(university of North Carolina-15 periodontal probe- Hu-Friedy, Chicago, IL, USA)'}], 'secondaryOutcomes': [{'measure': 'Plaque Index', 'timeFrame': '3 months', 'description': 'measured on the tooth surface using a probe'}, {'measure': 'Gingival index', 'timeFrame': '3 month', 'description': 'measured on the tooth surface using a probe'}, {'measure': 'Modified Sulcus Bleeding Index', 'timeFrame': '3 months', 'description': 'measured on the tooth surface using a probe'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Periodontal Pocket']}, 'descriptionModule': {'briefSummary': 'The current study is a prospective randomised study Evaluation of 2%Bromelain Gel With 0.2%Chlorhexidine Gel as Subgingival Local Drug Delivery Following Scaling and Root Planing in Stage II/III and Grade B Periodontitis', 'detailedDescription': '36 sites with periodontal pocket depth measuring 4-6mm were selected. The sites selected were divided into\n\n1. Group I (Control)- 12 sites with Probing depth of ≥5mm treated with scaling and root planing alone.\n2. Group II -12 sites with Probing depth of ≥5mm treated with scaling and root planing followed by placement of bromelain gel.\n3. Group III -12 sites with Probing depth of ≥5mm treated with scaling and root planing followed by placement of chlorhexidine gel.\n\nperiodontal pack was placed and patient was recalled at 1week,4th week and 12th week'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with have chronic periodontitis in the age group between 30-50 years.\n* Patients having ≥20 teeth.\n\n -.Patients with radiographic evidence of bone loss in atleast two teeth.\n* Patients who are systematically healthy.\n* Patients with localized pockets with probing depth of ≤ 5mm.\n* Patients who are cooperative and able to attend the hospital for regular follow-up.\n\nExclusion Criteria:\n\n* Patients who have received any surgical or nonsurgical therapy during past 6months\n* Pregnant or lactating females.\n* Use of systemic antibiotics in the past 6 months.\n* Patient who are not willing to give a written informed consent'}, 'identificationModule': {'nctId': 'NCT06505759', 'briefTitle': 'Evaluation of 2%Bromelain Gel With 0.2%CHX Gel as Subgingival LDD Following SRP in Stage II/III and Grade B Periodontitis -A RCT', 'organization': {'class': 'OTHER', 'fullName': 'Krishnadevaraya College of Dental Sciences & Hospital'}, 'officialTitle': 'Evaluation of 2%Bromelain Gel With 0.2%Chlorhexidine Gel as Subgingival Local Drug Delivery Following Scaling and Root Planing in Stage II/III and Grade B Periodontitis -Randomized Control Clinical Trail', 'orgStudyIdInfo': {'id': '02-D012-147453'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'GROUP 1-SRP alone', 'description': 'control group is treated with SRP alone', 'interventionNames': ['Procedure: SRP']}, {'type': 'EXPERIMENTAL', 'label': 'GROUP 2-0.2% BROMELAIN gel', 'description': 'test group is treated with bromelain gel', 'interventionNames': ['Drug: Bromelain gel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'GROUP 3-0.2% CHLORHEXIDINE gel', 'description': 'test group is treated with chlorhexidine gel', 'interventionNames': ['Drug: chlorhexidine gel']}], 'interventions': [{'name': 'Bromelain gel', 'type': 'DRUG', 'description': 'bromelain gel is prepared from bromelain capsules in laboratory', 'armGroupLabels': ['GROUP 2-0.2% BROMELAIN gel']}, {'name': 'chlorhexidine gel', 'type': 'DRUG', 'description': 'chlorhexidine gel is prepared from mouth wash', 'armGroupLabels': ['GROUP 3-0.2% CHLORHEXIDINE gel']}, {'name': 'SRP', 'type': 'PROCEDURE', 'description': 'Scaling and root planing was done with ultra sonic and hand scaling', 'armGroupLabels': ['GROUP 1-SRP alone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '562157', 'city': 'Bengaluru', 'state': 'Karnataka', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Dr. MLV Prabhuji', 'role': 'CONTACT'}], 'facility': 'Dr. NALLAGATLA VAMSI VENKATA KRISHNA SAI', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}], 'centralContacts': [{'name': 'DR .Prabhuji MLV, MDS', 'role': 'CONTACT', 'email': 'prabhujimlv@gmail.com', 'phone': '9448057407'}, {'name': 'DR.NALLAGATLA VAMSI VENKATAKRISHNA SAI, MDS', 'role': 'CONTACT', 'email': 'vamsi.prince.sai17@gmail.com', 'phone': '8499086673', 'phoneExt': '91'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Krishnadevaraya College of Dental Sciences & Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}