Ignite Creation Date:
2025-12-25 @ 3:33 AM
Ignite Modification Date:
2025-12-26 @ 2:15 AM
Study NCT ID:
NCT07041905
Status:
RECRUITING
Last Update Posted:
2025-07-22
First Post:
2025-06-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Total and Selective Caries Removal - Requiring or Avoiding Vital Pulp Therapy - on Pulp Vitality and Postoperative Pain in Deep Carious Mature Permanent Teeth: A Split-Mouth Clinical Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003789', 'term': 'Dental Pulp Exposure'}], 'ancestors': [{'id': 'D003788', 'term': 'Dental Pulp Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Patients and outcome assessors were blinded to the intervention groups. The operator was not blinded due to the visible differences between total and selective caries removal techniques.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-17', 'studyFirstSubmitDate': '2025-06-19', 'studyFirstSubmitQcDate': '2025-06-19', 'lastUpdatePostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Early postoperative pain intensity (VAS) after total vs. selective excavation', 'timeFrame': 'first week', 'description': 'The patient will be asked to rate his/her pain on day 1, 3 and 7 according to VAS'}, {'measure': 'dentin bridge formation', 'timeFrame': 'twelve months', 'description': 'no dentin bridge formation is expected in selective caries cleaning, while dentin bridge formation will be observed radiologically in total cleaning'}, {'measure': 'pulp survival at twelve months', 'timeFrame': 'twelve months', 'description': 'The pulp is expected to remain vital, with no percussion tenderness and no spontaneous pain'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulp Exposure, Dental', 'Deep Dental Caries']}, 'descriptionModule': {'briefSummary': 'The effect of selective caries cleaning and total caries cleaning on pulp health and post operative pain in teeth with deep caries will be investigated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '55 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged ≥15 years with bilateral deep carious mature permanent teeth.\n* Positive vitality test (cold sensitivity).\n* No spontaneous pain or periapical radiolucency.\n* Willingness to attend 6- and 12-month follow-ups\n\nExclusion Criteria:\n\n* Uncontrolled systemic diseases Pregnancy or allergy to dental materials used Teeth with irreversible pulpitis (spontaneous pain, necrosis) Non-restorable teeth (fractures, extensive decay)'}, 'identificationModule': {'nctId': 'NCT07041905', 'briefTitle': 'Effects of Total and Selective Caries Removal - Requiring or Avoiding Vital Pulp Therapy - on Pulp Vitality and Postoperative Pain in Deep Carious Mature Permanent Teeth: A Split-Mouth Clinical Study', 'organization': {'class': 'OTHER', 'fullName': 'Cukurova University'}, 'officialTitle': 'Effects of Total and Selective Caries Removal - Requiring or Avoiding Vital Pulp Therapy - on Pulp Vitality and Postoperative Pain in Deep Carious Mature Permanent Teeth: A Split-Mouth Clinical Study', 'orgStudyIdInfo': {'id': 'D-SCR-2025-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 1', 'description': 'Complete caries excavation', 'interventionNames': ['Procedure: Total Caries Removal']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'description': 'Partial caries excavation', 'interventionNames': ['Procedure: Selective Caries Removal']}], 'interventions': [{'name': 'Total Caries Removal', 'type': 'PROCEDURE', 'description': 'Arm 1: "Total caries removal (complete excavation to hard dentin)"', 'armGroupLabels': ['Arm 1']}, {'name': 'Selective Caries Removal', 'type': 'PROCEDURE', 'description': 'Partial removal leaving affected dentin near pulp.', 'armGroupLabels': ['Arm 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Adana', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Cukurova University Cukurova University Faculty of Dentistry', 'role': 'CONTACT', 'email': 'dhf@cu.edu.tr', 'phone': '0322 338 73 30'}], 'facility': 'Cukurova University', 'geoPoint': {'lat': 36.98615, 'lon': 35.32531}}], 'centralContacts': [{'name': 'Zehra Zehra Susgun Yıldırım, Principal investigator', 'role': 'CONTACT', 'email': 'susgunzehra@gmail.com', 'phone': '0553 454 1123'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cukurova University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Zehra SUSGUN YILDIRIM', 'investigatorAffiliation': 'Cukurova University'}}}}