Ignite Creation Date:
2025-12-24 @ 3:55 PM
Ignite Modification Date:
2025-12-26 @ 11:20 AM
Study NCT ID:
NCT06775392
Status:
COMPLETED
Last Update Posted:
2025-01-15
First Post:
2025-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Evaluation of Bromelain-Quercetin Gel With Chlorhexidine Gel as Subgingival Local Drug Delivery Following Scaling and Root Planing In Stage I /II and Grade B Periodontitis - Randomized Control Clinical Trail
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': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-09', 'studyFirstSubmitDate': '2025-01-09', 'studyFirstSubmitQcDate': '2025-01-09', 'lastUpdatePostDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PROBING POCKET DEPTH', 'timeFrame': '21DAYS', 'description': 'measured using a UNC-15 probe (university of North Carolina-15 periodontal probe- Hu-Friedy, Chicago, IL, USA'}, {'measure': 'CLINICAL ATTACHMENT LEVEL', 'timeFrame': '21DAYS', 'description': '(university of North Carolina-15 periodontal probe- Hu-Friedy, Chicago, IL, USA)'}], 'secondaryOutcomes': [{'measure': 'Plaque Index', 'timeFrame': '21DAYS', 'description': 'measured on the tooth surface using a probe'}, {'measure': 'Gingival index', 'timeFrame': '21DAYS', 'description': 'measured on the tooth surface using a probe'}, {'measure': 'Modified Sulcus Bleeding Index', 'timeFrame': '21days', 'description': 'measured on the tooth surface using a probe'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Periodontal Pocket']}, 'descriptionModule': {'briefSummary': 'Comparative Evaluation of Bromelain-Quercetin Gel With Chlorhexidine Gel as Subgingival Local Drug Delivery Following Scaling and Root Planing In Stage I /II and Grade B Periodontitis - Randomized Control Clinical Trail', 'detailedDescription': ': Periodontitis is a biofilm associated disease that induces an irreversible inflammatory state that leads to the destruction of the supporting structure of the teeth. Management of periodontal disease is through thorough removal of biofilm which is pivotal for having better oral health. Scaling and root planning (SRP) is fundamental treatment for periodontitis. Years of documented research have established that chlorhexidine digluconate (CHX), gold standard of chemical plaque control agent is safe stable and effective in preventing and controlling plaque formation. Bromelain is an extract derived from Ananas comosus (popularly known as pineapple), contains proteinases that exhibits anti-inflammatory properties, antibacterial effect against periodontopathogens. Bromelain gel has shown to have chemicomechanical method of caries removal. Quercetin present in guava have excellent antibacterial actions against periodontal pathogens, Aggregatibacter actinomycetemcomitans (Aa), Porphyromonas gingivalis (Pg), Prevotella intermedia (Pi) and Fusobacterium nucleatum (Fn). 2% Quercetin has shown to be advantageous for subgingival application after scaling and rootplaning. Bromelain-Quercetin gel has shown adjunctive effect for treatment in covid-19 patients. As there is less literature in this combination, we intend to study its effects. Individually bromelain and quercetin have been studied for treatment in oral cavity as gel form. This study will be first of its kind to check the efficacy of 2% bromelain-quercetin gel and to compare its effects with 0.2% Chlorhexidine in stage I/II and grade B periodontits.'}, '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': 'NCT06775392', 'briefTitle': 'Comparative Evaluation of Bromelain-Quercetin Gel With Chlorhexidine Gel as Subgingival Local Drug Delivery Following Scaling and Root Planing In Stage I /II and Grade B Periodontitis - Randomized Control Clinical Trail', 'organization': {'class': 'OTHER', 'fullName': 'Krishnadevaraya College of Dental Sciences & Hospital'}, 'officialTitle': 'Comparative Evaluation of Bromelain-Quercetin Gel With Chlorhexidine Gel as Subgingival Local Drug Delivery Following Scaling and Root Planing In Stage I /II and Grade B Periodontitis - Randomized Control Clinical Trail', 'orgStudyIdInfo': {'id': 'KCDSHEC/IP/2023/V1/P4a'}}, '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-2-2%bromelain-quercetin gel', 'description': 'test group treated with 2%bromelain-quercetin gel', 'interventionNames': ['Drug: bromelain-quercetin gel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group-3-0.2% chlorhexidine gel', 'description': 'test group treated with chlorhexidine gel', 'interventionNames': ['Drug: chlorhexidine gel']}], 'interventions': [{'name': 'bromelain-quercetin gel', 'type': 'DRUG', 'description': 'bromelain-quercetin gel is prepared from capsules in laboratory', 'armGroupLabels': ['Group-2-2%bromelain-quercetin gel']}, {'name': 'chlorhexidine gel', 'type': 'DRUG', 'description': 'chlorhexidine gel is prepared in laboratory', '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', 'country': 'India', 'facility': 'Dr. NALLAGATLA VAMSI VENKATA KRISHNA SAI', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Krishnadevaraya College of Dental Sciences & Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}