Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-27 @ 10:52 PM
Study NCT ID:
NCT06146894
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2023-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Different Obturation Techniques on Postobturation Pain in Single-Visit Root Canal Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D001733', 'term': 'Bites and Stings'}], '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'}, {'id': 'D011041', 'term': 'Poisoning'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-06-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-05', 'studyFirstSubmitDate': '2023-11-17', 'studyFirstSubmitQcDate': '2023-11-24', 'lastUpdatePostDateStruct': {'date': '2024-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postobturation pain', 'timeFrame': '30 days', 'description': 'Presence of post-obturation pain will accessed by visual analog scale (VAS) scale (0-10), where 0 showed no pain, 1-3 mild pain, 4-6 moderate pain, 7-9 severe pain, and 10 worst possible pain.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postoperative Pain', 'Bioceramic sealer', 'Obturation'], 'conditions': ['Postoperative Pain']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/36385378/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The goal of this prospective clinical randomized study is to evaluate the effect of different obturation techniques on postobturation pain in single-visit root canal treatment in 18-60 years old patient who present no systemic disease (American Society of Anesthesiology class I or II) and require nonsurgical root canal treatment The main question it aims to answer which obturation technique used with bioceramic sealer cause less postobturation pain in single-visit root canal treatment in comparison to AH plus sealer used with lateral condensation or warm vertical compaction.\n\nParticipants will receive single visit root canal treatment using bioceramic sealer with different obturation techniques Group 1: Single cone technique Group 2: lateral condensation technique Group 3: Vertical compaction technique to see effect of different obturation technique on postobturation pain in single-visit root canal treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18-60 years who presented no systemic disease (American Society of Anesthesiology class I or II) and required nonsurgical root canal treatment.\n* Diagnosis of asymptomatic irreversible pulpitis in a molar tooth with 3 independent root canals.\n\nExclusion Criteria:\n\n* Presence of immature root apexes, root fracture, or periodontal disease\n* Use of any analgesic, anti- inflammatory, or antibiotics before the treatment.'}, 'identificationModule': {'nctId': 'NCT06146894', 'briefTitle': 'The Effect of Different Obturation Techniques on Postobturation Pain in Single-Visit Root Canal Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Kafrelsheikh University'}, 'officialTitle': 'The Effect of Different Obturation Techniques on Postobturation Pain in Single-Visit Root Canal Treatment: A Prospective Clinical Randomized Study', 'orgStudyIdInfo': {'id': 'HA2427'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single cone technique (Bioceramic Sealer)', 'interventionNames': ['Procedure: Single obturation technique (Bioceramic Sealer)']}, {'type': 'EXPERIMENTAL', 'label': 'lateral condensation technique (Bioceramic Sealer)', 'interventionNames': ['Procedure: lateral condensation technique (Bioceramic Sealer)']}, {'type': 'EXPERIMENTAL', 'label': 'Warm Vertical condensation technique (Bioceramic Sealer)', 'interventionNames': ['Procedure: Warm Vertical condensation technique (Bioceramic Sealer)']}, {'type': 'EXPERIMENTAL', 'label': 'lateral condensation technique (AH plus Sealer)', 'interventionNames': ['Procedure: lateral condensation technique (AH Plus Sealer)']}, {'type': 'EXPERIMENTAL', 'label': 'Warm Vertical condensation technique (AH plus Sealer)', 'interventionNames': ['Procedure: Warm Vertical condensation technique (AH plus Sealer)']}], 'interventions': [{'name': 'Single obturation technique (Bioceramic Sealer)', 'type': 'PROCEDURE', 'description': 'Root canal will be obturated using single cone technique using Bioceramic Sealer', 'armGroupLabels': ['Single cone technique (Bioceramic Sealer)']}, {'name': 'lateral condensation technique (Bioceramic Sealer)', 'type': 'PROCEDURE', 'description': 'Root canal will be obturated using lateral condensation technique using Bioceramic Sealer', 'armGroupLabels': ['lateral condensation technique (Bioceramic Sealer)']}, {'name': 'Warm Vertical condensation technique (Bioceramic Sealer)', 'type': 'PROCEDURE', 'description': 'Root canal will be obturated using vertical condensation technique using Bioceramic Sealer', 'armGroupLabels': ['Warm Vertical condensation technique (Bioceramic Sealer)']}, {'name': 'lateral condensation technique (AH Plus Sealer)', 'type': 'PROCEDURE', 'description': 'Root canal will be obturated using lateral condensation technique using AH plus Sealer', 'armGroupLabels': ['lateral condensation technique (AH plus Sealer)']}, {'name': 'Warm Vertical condensation technique (AH plus Sealer)', 'type': 'PROCEDURE', 'description': 'Root canal will be obturated using vertical condensation technique using AH plus Sealer', 'armGroupLabels': ['Warm Vertical condensation technique (AH plus Sealer)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33511', 'city': 'Kafr ash Shaykh', 'state': 'Kafr El-Shaikh', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'hisham abada, phd', 'role': 'CONTACT'}], 'facility': 'kafrelsheikh University', 'geoPoint': {'lat': 31.11174, 'lon': 30.93991}}], 'centralContacts': [{'name': 'Hisham Abada, PhD', 'role': 'CONTACT', 'email': 'Hisham.dentist@gmail.com', 'phone': '01003772427', 'phoneExt': '002'}], 'overallOfficials': [{'name': 'Hisham Abada, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kafrelsheikh University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kafrelsheikh University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Hisham Mahmoud Hamdy Abada', 'investigatorAffiliation': 'Kafrelsheikh University'}}}}