Ignite Creation Date:
2025-12-26 @ 11:13 AM
Ignite Modification Date:
2025-12-31 @ 12:20 PM
Study NCT ID:
NCT07014228
Status:
COMPLETED
Last Update Posted:
2025-06-10
First Post:
2025-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Post-operative Pain During Retreatment in Different Visits
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be divided into two equal groups and given two different interventions (single vs. multi-visit reendo).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 116}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-09', 'studyFirstSubmitDate': '2025-06-01', 'studyFirstSubmitQcDate': '2025-06-09', 'lastUpdatePostDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post operative pain after re-endo', 'timeFrame': '6 hours - 72 hours', 'description': 'Post-operative pain after single vs multi visit re-endo treatment to be compared. The patients will be guided in detail about the procedure and how to document their response to the treatment. The Visual Analog Scale (VAS). numbered from 0-10, with 0 being no pain, 1 - 3: mild pain, 4-6: moderate pain, and 7-10 severe pain, will be used to record pain experienced by the patients and notified to the investigator.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post Operative Pain']}, 'descriptionModule': {'briefSummary': 'Endodontic retreatment is performed to alleviate symptoms of recurring infection, post-treatment disease after primary endodontic therapy. Retreatment can be performed in either single or multiple visits. and have their own implications. it is important to compare the patient response and post-op pain after single vs multi-visit reendo treatment.', 'detailedDescription': 'Introduction:\n\nTreating endodontic failure cases has always been a challenge for the clinician due to the complex nature of disease which includes resistant microorganisms, iatrogenic errors and cleaning and shaping of un-instrumented areas. Endodontic retreatment can be done in either single or multiple visits. Multiple visits have the added advantage of placement of intracanal medicament resulting in decreased bacterial load and reduced pain, whereas single visit endodontic retreatment reduces chances of inter appointment microbial contamination. This study aims to evaluate post operative pain among both groups.\n\nObjective:\n\nTo evaluate frequency of post-operative pain in endodontic retreatment cases after single vs multiple (two) visits root canal therapy.\n\nMaterials and Methods:\n\nSTUDY SETTING: Department of Operative Dentistry, AFID Rawalpindi.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with unremarkable/ noncontributory medical history\n* Age range between 15-45 years\n* Cases of failed endodontic treatment resulting from inadequate root filling\n* No systemic disease\n* No periodontal disease\n\nExclusion Criteria:\n\n* Patients having teeth with periodontal pathology\n* root fractures\n* Immature root apices\n* Endodontic posts\n* Root perforations\n* Immunocompromised health were excluded from the study.'}, 'identificationModule': {'nctId': 'NCT07014228', 'briefTitle': 'Evaluation of Post-operative Pain During Retreatment in Different Visits', 'organization': {'class': 'OTHER', 'fullName': 'Armed Forces Institute of Dentistry, Pakistan'}, 'officialTitle': 'Evaluation of Post Operative Pain in Non-surgical Endodontic Retreatment in Single vs Multiple Visits', 'orgStudyIdInfo': {'id': 'Re-endo pain comparison'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single visit group', 'description': 'Endodontic retreatment in this group will be performed in a single visit. Initiated, deobturated, disinfection done and completed during the same visit.', 'interventionNames': ['Procedure: single visit re-endo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Multi visit Group', 'description': 'Endodontic retreatment in this group will be performed in more than 1 visit. The retreatment will be initiated, deobturated, and disinfection done and completed in second or third visits..', 'interventionNames': ['Procedure: multi visit re-endo']}], 'interventions': [{'name': 'single visit re-endo', 'type': 'PROCEDURE', 'description': 'In this group, a single visit re-endodontic treatment will be performed and completed in the same visit, including all the steps.', 'armGroupLabels': ['Single visit group']}, {'name': 'multi visit re-endo', 'type': 'PROCEDURE', 'description': 'In this group, a multi-visit re-endodontic treatment will be performed and completed over different visits, including all the steps.', 'armGroupLabels': ['Multi visit Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64000', 'city': 'Rawalpindi', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Armed Forces Institute of dentistry', 'geoPoint': {'lat': 33.59733, 'lon': 73.0479}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Armed Forces Institute of Dentistry, Pakistan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Ahmed Abdullah', 'investigatorAffiliation': 'Armed Forces Institute of Dentistry, Pakistan'}}}}