Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-30 @ 8:32 PM
Study NCT ID:
NCT05682833
Status:
UNKNOWN
Last Update Posted:
2023-01-12
First Post:
2022-12-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adjunctive Use Of A Novel Hyaluronic Acid/Chlorhexidine Gel In The Non Surgical Treatment Of 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Split mouth RCT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2024-06-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-10', 'studyFirstSubmitDate': '2022-12-28', 'studyFirstSubmitQcDate': '2023-01-10', 'lastUpdatePostDateStruct': {'date': '2023-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pocket depth', 'timeFrame': '2 months'}, {'measure': 'Bleeding on Probing', 'timeFrame': '2 months'}, {'measure': 'Clinical attachment level', 'timeFrame': '2 months'}], 'secondaryOutcomes': [{'measure': 'Plaque index', 'timeFrame': '2 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Periodontitis', 'Hyaluronic Acid', 'Chlorhexidine']}, 'descriptionModule': {'briefSummary': 'General Objective :\n\nTo evaluate the outcome of non surgical periodontal therapy with local drug delivery adjunct to scaling and root planning\n\nSpecific Objective :\n\nTo determine the effect of intra-pocket application of hyaluronic acid /chlorohexidine gel in non surgical periodontal treatment on clinical periodontal parameters and microbiological level .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age : 20-60 years old\n* At least 20 remaining teeth\n* Periodontitis stage III and IV ,Grade A, B and C\n\nExclusion Criteria:\n\n* Patients taking specific medications: antibiotic , anticoagulants or anti-inflammatory\n* Previous periodontal therapy in the past 3-6 months.\n* Immunocompromised patients\n* Systemically diseased patients: Diabetes ,osteoporosis etc\n* History of allergies or hypersensitivity reactions to chlorohexidine or Hyaluronic acid\n* Pregnant or lactating women.\n* Heavy Smokers (more than 20/day)'}, 'identificationModule': {'nctId': 'NCT05682833', 'briefTitle': 'Adjunctive Use Of A Novel Hyaluronic Acid/Chlorhexidine Gel In The Non Surgical Treatment Of Periodontitis', 'organization': {'class': 'OTHER', 'fullName': 'University of Sharjah'}, 'officialTitle': 'Adjunctive Use Of A Novel Hyaluronic Acid/Chlorhexidine Gel In The Non Surgical Treatment Of Periodontitis: A Split Mouth Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'REC-22-02-26-S'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test', 'description': 'NS therapy + Chlorhexidine/Hyaluronic acid subgingival gel application', 'interventionNames': ['Procedure: Non surgical periodontal therapy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'NS therapy + Placebo gel subgingival application', 'interventionNames': ['Procedure: Non surgical periodontal therapy']}], 'interventions': [{'name': 'Non surgical periodontal therapy', 'type': 'PROCEDURE', 'description': 'Subgingival ultrasonic debridement + manual root planning', 'armGroupLabels': ['Control', 'Test']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sharjah city', 'status': 'RECRUITING', 'country': 'United Arab Emirates', 'contacts': [{'name': 'Zahi BADRAN', 'role': 'CONTACT', 'email': 'zbadran@sharjah.ac.ae'}], 'facility': 'University Dental Hospital Sharjah', 'geoPoint': {'lat': 25.3342, 'lon': 55.41221}}], 'centralContacts': [{'name': 'Prof. Zahi Badran Prof.', 'role': 'CONTACT', 'email': 'zbadran@sharjah.ac.ae', 'phone': '+97165057353'}], 'overallOfficials': [{'name': 'Zahi BADRAN, Phd', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Sharjah'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sharjah', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Zahi BADRAN', 'investigatorAffiliation': 'University of Sharjah'}}}}