Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-25 @ 9:47 PM
Study NCT ID:
NCT05427851
Status:
UNKNOWN
Last Update Posted:
2022-06-22
First Post:
2022-06-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Diode Laser Pulpotomy of Mature Permanent Molars With Irreversible Pulpitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011672', 'term': 'Pulpotomy'}], 'ancestors': [{'id': 'D004708', 'term': 'Endodontics'}, {'id': 'D003813', 'term': 'Dentistry'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-19', 'studyFirstSubmitDate': '2022-06-12', 'studyFirstSubmitQcDate': '2022-06-19', 'lastUpdatePostDateStruct': {'date': '2022-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Dentine bridge formation', 'timeFrame': '12 months', 'description': 'To evaluate the effect of Diode laser on the enhancement of dentin bridge formation following pulpotomy procedure using CBCT.'}], 'primaryOutcomes': [{'measure': 'regenerative pulpotomy success', 'timeFrame': '12 months', 'description': 'Assessing the clinical and radiographic success rate of the regenerative pulpotomy. • Teeth were considered as clinical success if patients had lack of pain (spontaneous or on chewing), sinus tract or swelling, pathological mobility, and had intact coronal restoration.( procedure done in permanent mature teeth with irreversible pulpitis.\n\nTreatment was considered radiographically successful if no pathosis was evident on the recall radiograph such as root resorption, no furcal or periapical rarefaction. Periapical Index (PAI) was used to evaluate the periapical tissue condition by comparing the pre-operative radiographs with the follow-up radiographs.'}], 'secondaryOutcomes': [{'measure': 'Postoperative pain', 'timeFrame': '7 days', 'description': 'To evaluate the effect of Diode laser on decreasing the immediate postoperative pain. Postoperative pain was recorded on Numerical Rating Pain Scale (NRS) that was given to the patient in Arabic language to record his pain experience every 24 hours until the seventh day after the first appointment.\n\nPain on the NRS was further categorized as:(0)no pain, (1-3) mild, (4-6) moderate, (7-10) Severe pain.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Irreversible Pulpitis']}, 'descriptionModule': {'briefSummary': 'Thirty six patients are included in this study. For each patient, a pulpotomy procedure is performed.', 'detailedDescription': 'For each patient, a pulpotomy procedure is done. Group I (n=12) pulpotomy is performed and hemostasis is achieved by applying NaOCl, then the radicular pulp is covered with Platelet Rich Fibrin (PRF) and capped with Biodentine, Group II (n=12) pulpotomy is done as in group I and hemostasis is achieved using diode laser and remaining pulp is capped with Biodentine, Group III (n=12) pulpotomy is performed and hemostasis is achieved as in group II then radicular pulp is covered with PRF then capped with Biodentine, The teeth are then restored with Glass ionomer cement followed by composite restoration. Pain is recorded every 24 hours for 7 days after intervention. Clinical and radiographic follow-up are done at 1,3,6,9 and 12 months. Cone beam computed tomography (CBCT) is done immediate postoperative and will be used for the assessment of the outcome of the pulpotomy procedure at the end of the study period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients between 18 and 40 years of age.\n2. Deep caries in a permanent lower molar with mature roots.\n3. Clinical diagnosis of symptomatic irreversible pulpitis\n4. No signs of pulpal necrosis including sinus tract or swelling.\n5. Vital bleeding pulp tissue should be present in all canals after complete pulpotomy.\n6. The tooth is restorable.\n\nExclusion Criteria:\n\n1. Patients with systemic disease.\n2. Negative response to cold testing.\n3. Presence of sinus tract or swelling.\n4. No pulp exposure after caries excavation.\n5. Bleeding could not be controlled\n6. Absence of bleeding from any of the canals.\n7. Teeth with radiographic signs of internal resorption.\n8. Pulpal calcifications.\n9. Non-restorable teeth'}, 'identificationModule': {'nctId': 'NCT05427851', 'briefTitle': 'Diode Laser Pulpotomy of Mature Permanent Molars With Irreversible Pulpitis', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Effect Of Diode Laser And Platelet Rich Fibrin In Regenerative Pulpotomy Of Mature Permanent Molars With Irreversible Pulpitis (A Randomized Controlled Clinical Trial)', 'orgStudyIdInfo': {'id': 'Darinemamdouh'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group I: Platelet rich Fibrin (PRF) and Biodentine', 'interventionNames': ['Procedure: pulpotomy']}, {'type': 'EXPERIMENTAL', 'label': 'Group II: Diode Laser and Biodentine', 'interventionNames': ['Procedure: pulpotomy', 'Device: Diode laser - fonalaser']}, {'type': 'EXPERIMENTAL', 'label': 'Group III: Diode laser + PRF + Biodentine', 'interventionNames': ['Procedure: pulpotomy', 'Device: Diode laser - fonalaser']}], 'interventions': [{'name': 'pulpotomy', 'type': 'PROCEDURE', 'description': 'coronal pulp tissue removal followed by radicular pulp hemostasis them applying a pulp capping material', 'armGroupLabels': ['Group I: Platelet rich Fibrin (PRF) and Biodentine', 'Group II: Diode Laser and Biodentine', 'Group III: Diode laser + PRF + Biodentine']}, {'name': 'Diode laser - fonalaser', 'type': 'DEVICE', 'description': 'diode laser beam application', 'armGroupLabels': ['Group II: Diode Laser and Biodentine', 'Group III: Diode laser + PRF + Biodentine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Faculty of Dentistry, Alexandria University', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'overallOfficials': [{'name': 'Raef A sherif, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Professor of Endodontics, Faculty of Dentistry, Alexandria University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}