Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:43 AM
Study NCT ID:
NCT03527602
Status:
UNKNOWN
Last Update Posted:
2018-07-06
First Post:
2018-05-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
FE in Anterior Teeth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D010485', 'term': 'Periapical Periodontitis'}], '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': 'D010483', 'term': 'Periapical Diseases'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D010518', 'term': 'Periodontitis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Single-blind. (Participants)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2018-08-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-03', 'studyFirstSubmitDate': '2018-05-03', 'studyFirstSubmitQcDate': '2018-05-16', 'lastUpdatePostDateStruct': {'date': '2018-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '100-mm Visual Analog Scale (VAS).', 'timeFrame': '5 days', 'description': 'The severity of pain in 12 h, 24 h, and 2, 3, 4, and 5 days according to the VAS: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)'}], 'secondaryOutcomes': [{'measure': 'The number of patients taking an analgesic following the endodontics treatment.', 'timeFrame': '5 days', 'description': 'The patients were asked to take an analgesic in the 5 days of time frame.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Apical patency', 'Endodontics'], 'conditions': ['Pain, Postoperative', 'Apical Periodontitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether enlarging the apical foramen causes postoperative pain in maxillary anterior teeth with apical periodontitis.', 'detailedDescription': 'Foraminal enlargement (FE) is an intentional procedure that enlarges the cement canal. However, some RCTs indicate that enlarging the FE causes postoperative pain, flare-up, and destroy the apical constriction, whilst some RCTs pointed out there is no difference in terms of pain when a FE has been performed in maxillary anterior teeth with apical periodontitis. We will assess the risk of postoperative pain as risk ratio (RR). The binary (dichotomous) data: 0-44 mm: Mild or no pain; 45-100 mm: Moderate to severe pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMature permenent maxillary anterior teeth having pulpal necrosis and apical periodontitis.\n\nExclusion Criteria:\n\nSystemic disorders, diabetes, pregnancy, less than 18 years of age, immunocompromised, patients who had taken antibiotics in the past 1 month, patients who had a positive history of analgesic use within the past 3 days, previously accessed teeth.'}, 'identificationModule': {'nctId': 'NCT03527602', 'briefTitle': 'FE in Anterior Teeth', 'organization': {'class': 'OTHER', 'fullName': 'Isparta Military Hospital'}, 'officialTitle': 'Enlargement of Apical Foramen in Anterior Teeth With Apical Periodontitis and Postoperative Pain and Flare-up Rate.', 'orgStudyIdInfo': {'id': 'IAH-5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Endodontic treatment will be performed in maxillary anterior teeth with necrotic pulp and periapical periodontitis. Local anaesthesia will be provided (2% Novocaine with 1:80,000 epinephrine), isolation with rubber dam and standard access cavity preparation will be done.Using 2.5 % sodium hypochlorite, canal negotiation will be done. Foraminal enlargement will be achieved with rotary files in foraminal enlargement group after determining working length. Coronal flaring with # 2 and #3 Gates-Glidden drills will be done. The canals will be obturated with gutta-percha and epoxy resin sealer. The treatments will be carried out in single-visit.', 'interventionNames': ['Procedure: Foraminal enlargement']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'In the control group, no foraminal enlargement will be performed.'}], 'interventions': [{'name': 'Foraminal enlargement', 'type': 'PROCEDURE', 'description': 'After determining the working length, a rotary file will be inserted 1 mm beyond the WL and the apical foramen will be enlarged.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32010', 'city': 'Isparta', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Ibrahim E YAYLALI, Ph.D.', 'role': 'CONTACT', 'email': 'ibotenring@yahoo.com'}], 'facility': 'Isparta Military Hospital', 'geoPoint': {'lat': 37.76444, 'lon': 30.55222}}], 'centralContacts': [{'name': 'ibrahim Ethem Yaylali, PhD', 'role': 'CONTACT', 'email': 'ibotenring@yahoo.com', 'phone': '05378707924'}, {'name': 'ibrahim E Yaylali, PhD', 'role': 'CONTACT', 'email': 'ibotenring@yahoo.com', 'phone': '05378707924'}], 'overallOfficials': [{'name': 'ibrahim ethem yaylali', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Military Hospital, Isparta'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Isparta Military Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Dentistry', 'investigatorFullName': 'Ibrahim Ethem YAYLALI', 'investigatorAffiliation': 'Isparta Military Hospital'}}}}