Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
Study NCT ID:
NCT06675058
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-05
First Post:
2024-11-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Caries Location and Its Effect on the Success Rate of Indirect Pulp Treatment in Primary Molars
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003788', 'term': 'Dental Pulp Diseases'}, {'id': 'D011671', 'term': 'Pulpitis'}, {'id': 'D003731', 'term': 'Dental Caries'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D017001', 'term': 'Tooth Demineralization'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'a Selective Case Study ( Prospective Clinical Trial)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-08-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-04', 'studyFirstSubmitDate': '2024-11-04', 'studyFirstSubmitQcDate': '2024-11-04', 'lastUpdatePostDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical success rate of primary molars with deep occlusal or proximal caries treated by Indirect Pulp Treatment (IPT)', 'timeFrame': 'one year follow up', 'description': 'Clinical success rate will be assess through assessment of the following :\n\nPost-operative Pain (percentage of absence of pain), Presence or absence of clinical signs (e.g., swelling, abscess, sinus tract), and Pain on Percussion'}], 'secondaryOutcomes': [{'measure': 'Radiographic success rate of primary molars with deep occlusal or proximal caries treated by Indirect Pulp Treatment (IPT).', 'timeFrame': 'one year follow up', 'description': 'Radiographic Success Rate will be assess every (6, and 12 months) through assessment of the following in the x-ray film :\n\nNo radiographic evidence of periapical or inter-radicular radiolucency, No internal or external root resorption, No furcation involvement, and No widening in the periodontal membrane ligament )'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Indirect Pulp Treatment', 'IPT', 'Caries location', 'Caries Site', 'Proximal and occlusal Caries', 'Proximal Caries', 'Occlusal Caries', 'Pulp Therapy', 'Reversible Pulpitis', 'Pulpitis', 'deciduous teeth', 'Caries in milk teeth'], 'conditions': ['Deep Caries Lesion of Primary Teeth', 'Dental Pulp Diseases', 'Deep Proximal Caries', 'Deep Occlusal Caries', 'Reversible Pulpitis', 'Pulpitis', 'Decayed Teeth']}, 'descriptionModule': {'briefSummary': 'The following study will be created to evaluate how the location of caries affects the effectiveness of indirect pulp treatment in primary molars. aiding in the development of evidence-based recommendations for pediatric dentists.', 'detailedDescription': 'A selective case study design will be employed, focusing on primary molars with either occlusal or proximal carious lesions. Children aged between 3 to 7 years meeting the inclusion criteria will be examined clinically and radiographically to assess the extent and location of the carious lesion. Two groups will be involved in the study; primary molars will be submitted to each group based on whether the lesion is proximal or occlusal. Both groups will then receive indirect pulp therapy, and a clinical and radiographic evaluation for one year will be conducted.\n\nThe purpose of this study is to examine how the location of caries, whether proximal or occlusal, affects the success rate of IPT in primary molars. Understanding this relationship is essential for developing more tailored clinical approaches in pediatric dentistry to ensure long-term treatment success.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant criteria:\n\n 1. Children aged between 3-7 years\n 2. Children in complete physical and mental health.\n 3. Children with free medical history.\n 4. Patient with favorable attitudes, which will be assessed by using Frankl behavior rating.\n\nTeeth criteria:\n\n1. Primary molars with active occlusal or proximal deep caries.\n2. Teeth with reversible pulpitis\n3. Asymptomatic teeth or teeth with provoked pain of short duration\n4. Teeth should be restorable.\n\nExclusion Criteria:\n\n* Clinical signs or symptoms suggesting evidence of pulp degeneration or a non -vital tooth such as:\n\n * Clinical symptoms or history indicating irreversible pulpitis as (spontaneous pain, throbbing pain).\n * Tenderness to percussion.\n * Soft tissue swelling, abscess, draining fistula or sinus tracts.\n * Pathological Tooth mobility.\n\nPresence of the following Radiographic criteria:\n\n* Periapical or inter-radicular radiolucency.\n* Internal or external pathological root resorption.\n* Furcation involvement\n* Widening of periodontal space.'}, 'identificationModule': {'nctId': 'NCT06675058', 'briefTitle': 'Caries Location and Its Effect on the Success Rate of Indirect Pulp Treatment in Primary Molars', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Caries Location and Its Effect on the Success Rate of Indirect Pulp Treatment in Primary Molars: A Comparative Clinical Study', 'orgStudyIdInfo': {'id': '14422023530604'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Primary teeth with deep proximal caries', 'description': 'In primary molars with deep proximal caries indirect pulp treatment will be performed by removing infected dentin while affected dentin in pulpal floor will be left in place. Teeth will be capped by a dressing material.', 'interventionNames': ['Procedure: Indirect Pulp Treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Primary teeth with deep occlusal caries', 'description': 'In primary molars with deep occlusal caries also IPT will be performed. Soft infected dentin will be carefully removed until the dried, hardened affected dentin with a leathery consistency reached then teeth will be capped by a dressing material', 'interventionNames': ['Procedure: Indirect Pulp Treatment']}], 'interventions': [{'name': 'Indirect Pulp Treatment', 'type': 'PROCEDURE', 'description': "Indirect pulp treatment is considered one of the most conservative pulp therapies, which preserves the pulp's vitality in teeth with reversible pulpitis. It has been chosen to be the intervention in both groups as the aim of this study is to assess the impact of caries location (proximal vs. occlusal caries) in influencing the success rate of IPT.", 'armGroupLabels': ['Primary teeth with deep occlusal caries', 'Primary teeth with deep proximal caries']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yomna Hussein Moselhy, Phd Candidate at Cairo Uni', 'role': 'CONTACT', 'email': 'dr.yomnahussein.edu@gmail.com', 'phone': '01145566717', 'phoneExt': '01090058699'}, {'name': 'Dr. Adel Abdel Azeem EL-Bardissy, Professor', 'role': 'CONTACT', 'email': 'adelbardissy@dentistry.cu.edu.eg', 'phone': '01271289999'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Yomna Hussein Moselhy', 'investigatorFullName': 'Yomna Hussein Moselhy Sayed Ahmed', 'investigatorAffiliation': 'Cairo University'}}}}