Ignite Creation Date:
2025-12-24 @ 2:42 PM
Ignite Modification Date:
2026-01-04 @ 11:09 AM
Study NCT ID:
NCT05538559
Status:
UNKNOWN
Last Update Posted:
2022-09-14
First Post:
2022-09-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Carie Care, Chemomechanical Caries Removal Technique in Primary Teeth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003731', 'term': 'Dental Caries'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-10', 'studyFirstSubmitDate': '2022-09-10', 'studyFirstSubmitQcDate': '2022-09-10', 'lastUpdatePostDateStruct': {'date': '2022-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time taken for caries removal', 'timeFrame': 'Through procedure completion', 'description': 'The time taken for the procedures will be measured from the beginning of caries removal procedure till the cavity is confirmed to be free of caries with the help of a stop watch and will be recorded in seconds.'}, {'measure': 'Efficacy of caries removal', 'timeFrame': 'Through procedure completion', 'description': 'Caries removal will be rated according to the scoring criteria that range between score zero where caries is removed completely to score 5 where caries is present at the base,walls and margins of the cavity'}, {'measure': 'Child pain perception', 'timeFrame': 'Through procedure completion', 'description': 'The type of response obtained for each observation was given a numerical value (score) like Score 1 (comfort), Score 2 (mild discomfort), Score 3 (moderately painful), and Score 4 (painful)'}, {'measure': 'Child behavior', 'timeFrame': 'Through procedure completion', 'description': "Score 1: Definitely positive, Good rapport with the dentist, interested in the dental procedures, laughing and enjoying the situation.\n\nScore 2: Positive, Acceptance of treatment; at times cautious, willingness to comply with the dentist, at times with reservation but patient follows the dentist's directions cooperatively.\n\nScore 3:Negative, Reluctant to accept treatment; uncooperative, some evidence of negative attitude but not pronounced, i.e. /sullen, withdrawn.\n\nScore 4: Definitely negative, Refusal of treatment, crying forcefully, fearful or any other overt evidence of extreme negativism."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dental Caries', 'Primary Teeth']}, 'descriptionModule': {'briefSummary': 'Chemomechanical caries removal systems have emerged as a possible valuable alternative to conventional rotary caries removal techniques in pediatric patients. Carie-Care™ is an economically minimally invasive approach that selectively removes caries-infected tissue leaving the caries-affected tissue to conserve tooth structure'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Open carious lesions with a moderately deep dentin carious lesion(scores five or six, according to the International Caries Detection and Assessment System\\[ICDAS\\].\n* The access of the carious lesion has to be large enough to allow the penetration of the excavator\n* Children with behavior rating 3 or 4 according to the Frankl scale\n\nExclusion Criteria:\n\n* Clinical or radiographic evidence of pulp, furcation, or periapical pathosis\n* Proximal caries evidenced by bitewing x-ray'}, 'identificationModule': {'nctId': 'NCT05538559', 'briefTitle': 'Carie Care, Chemomechanical Caries Removal Technique in Primary Teeth', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'The Effectiveness of Carie Care, Chemomechanical Caries Removal Technique in Primary Teeth (Randomized Controlled Clinical Trial)', 'orgStudyIdInfo': {'id': 'Caries Removal 2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test', 'interventionNames': ['Other: Chemomechanical caries removal by Carie-Care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'interventionNames': ['Other: Mechanical caries removal by Atraumatic Restorative Technique']}], 'interventions': [{'name': 'Chemomechanical caries removal by Carie-Care', 'type': 'OTHER', 'description': 'caries in primary teeth will be removed using Carie-Care™ the chemomechanical agent.', 'armGroupLabels': ['Test']}, {'name': 'Mechanical caries removal by Atraumatic Restorative Technique', 'type': 'OTHER', 'description': 'caries in primary teeth will be removed using the mechanical caries removal by ART method.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandria', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Alaa Y Ghanem, BDS', 'role': 'CONTACT', 'email': 'Alaaghanem952@gmail.com', 'phone': '01020208494'}], 'facility': 'Alexandria Faculty of Dentistry', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'centralContacts': [{'name': 'Alaa Y Ghanem, BDS', 'role': 'CONTACT', 'email': 'Alaaghanem952@gmail.com', 'phone': '01020208494'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hams Hamed Abdelrahman', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer of DPH and Clinical statistician', 'investigatorFullName': 'Hams Hamed Abdelrahman', 'investigatorAffiliation': 'Alexandria University'}}}}