Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT07058727
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-22
First Post:
2025-06-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Different Hemostatic Agents Used in Partial Pulpotomy on Pulp Survival and Postoperative Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002710', 'term': 'Chlorhexidine'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-17', 'studyFirstSubmitDate': '2025-06-19', 'studyFirstSubmitQcDate': '2025-06-30', 'lastUpdatePostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative Pain', 'timeFrame': '1 week', 'description': 'The patient will be asked to rate the pain on the 1st, 3rd and 7th day according to VAS. (The patient is asked to score their pain in this range, with 0 being the lowest and 10 being the highest.)'}, {'measure': 'Pulp Survival Rate', 'timeFrame': '12 months', 'description': 'The pulp is expected to be vital, without percussion tenderness and without spontaneous pain'}], 'secondaryOutcomes': [{'measure': 'Clinical Success', 'timeFrame': '12 months', 'description': 'Maintaining the integrity of the restoration No need for endodontics treatments'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Efficacy of Hemostatic Agents', 'Partial Pulpotomy', 'Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'This randomized clinical trial evaluates the efficacy of sodium hypochlorite (NaOCl), chlorhexidine (CHX), and cold saline as hemostatic agents in partial pulpotomy. The study compares postoperative pain (via VAS scores) and pulp survival (via clinical/radiographic evaluation) at 1, 3, 7 days, 6 months, and 12 months'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '55 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Permanent teeth with carious pulp exposure (no spontaneous pain).\n* Positive vitality test (Endo-Ice).\n* No periapical radiolucency.\n\nExclusion Criteria:\n\n* Systemic diseases affecting healing.\n* Pregnancy.\n* Non-vital pulp/necrosis'}, 'identificationModule': {'nctId': 'NCT07058727', 'briefTitle': 'Different Hemostatic Agents Used in Partial Pulpotomy on Pulp Survival and Postoperative Pain', 'organization': {'class': 'OTHER', 'fullName': 'Cukurova University'}, 'officialTitle': 'The Effect of Different Hemostatic Agents Used in Partial Pulpotomy on Pulp Survival and Postoperative Pain: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'PP-HemoRCT-2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': '2.5% NaOCl applied for 1 min after pulp exposure.', 'interventionNames': ['Drug: Sodium Hypochlorite 2,5%']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'description': '2% CHX applied for 1 min', 'interventionNames': ['Drug: Chlorhexidine']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3', 'description': 'Hemostasis achieved with 4°C saline for 1 min.', 'interventionNames': ['Drug: Cold Saline']}], 'interventions': [{'name': 'Sodium Hypochlorite 2,5%', 'type': 'DRUG', 'description': '2.5% NaOCl applied for 1 min to exposed pulp for hemostasis, followed by standard pulp capping', 'armGroupLabels': ['Arm 1']}, {'name': 'Chlorhexidine', 'type': 'DRUG', 'description': '2% CHX applied for 1 min to achieve hemostasis, with identical subsequent steps to NaOCl group', 'armGroupLabels': ['Arm 2']}, {'name': 'Cold Saline', 'type': 'DRUG', 'description': 'Hemostasis via 4°C saline (1 Min), then standardized pulp capping', 'armGroupLabels': ['Arm 3']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cukurova University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Zehra SUSGUN YILDIRIM', 'investigatorAffiliation': 'Cukurova University'}}}}