Ignite Creation Date:
2025-12-24 @ 1:00 PM
Ignite Modification Date:
2025-12-30 @ 2:09 AM
Study NCT ID:
NCT04358861
Status:
COMPLETED
Last Update Posted:
2020-04-24
First Post:
2020-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Healing Outcome of Root Canal Therapy in Maxillary Molars With DOM
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010485', 'term': 'Periapical Periodontitis'}], 'ancestors': [{'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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-22', 'studyFirstSubmitDate': '2020-04-17', 'studyFirstSubmitQcDate': '2020-04-22', 'lastUpdatePostDateStruct': {'date': '2020-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical and radiographic success', 'timeFrame': '12 months', 'description': 'long term clinical and radiographic success measured in terms of reduction in size of periapical radiolucency on radiograph from baseline to 12 months using PAI score 1,2 as healing and more than 2 as non healing'}], 'secondaryOutcomes': [{'measure': 'Number of canals located in MB root', 'timeFrame': '12 months', 'description': 'incidence of additional canals located in MB root'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dental Operating Microscope'], 'conditions': ['Periapical Periodontitis']}, 'descriptionModule': {'briefSummary': 'The aim of study was to evaluate the effect of dental operating microscope use on the healing outcome of non surgical endodontic treatment of maxillary molars.', 'detailedDescription': 'Prior to treatment a thorough clinical and radiological examination was carried out. A thorough history was taken from each patient and written informed consent was taken after explaining the procedure, risks and benefits. Mature maxillary first permanent molar with diagnosis of periapical periodontitis (as confirmed clinically \\& by periapical radiograph) was chosen for the study. Fifty participants were randomly assigned to either the dental operating microscope group or to control group (without using dental operating microscope) for the treatment.\n\nAfter administration of local anesthesia and rubber dam isolation of the involved tooth ; access cavity was prepared using carbide bur and refined using ultrasonic tip in both groups. In both the groups similar protocol for irrigation, obturation and post operative restorations was followed. Immediate post-operative radiograph was taken using preset exposure parameters and follow up clinical and radiographic examination was carried at 12th month.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient willing to participate in the study\n* Age \\> 18 years\n* Maxillary permanent first molar having apical periodontitis requiring primary endodontic treatment\n* Radiographic evidence of periapical radiolucency (minimum size 2 mmx 2 mm) and a diagnosis of pulpal necrosis as confirmed by negative response to cold and electrical tests and absence of bleeding on entering the pulp chamber\n\nExclusion Criteria:\n\n* Unwillingness of patient.\n* Retreatment cases\n* Presence of internal or external resorption ,root canal perforations during endodontic treatment and immature teeth.\n* Periodontally compromised teeth\n* Immunocompromised, diabetic, pregnant and hypertensive patients\n* Vertical root fractures\n* Teeth those are not suitable for rubber dam application'}, 'identificationModule': {'nctId': 'NCT04358861', 'briefTitle': 'Healing Outcome of Root Canal Therapy in Maxillary Molars With DOM', 'organization': {'class': 'OTHER', 'fullName': 'Postgraduate Institute of Dental Sciences Rohtak'}, 'officialTitle': 'Healing Outcome of Nonsurgical Root Canal Treatment in Maxillary Molars With Dental Operating Microscope : A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Neelam'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'Nonsurgical Root canal therapy was performed using dental operating microscope in the experimental group.', 'interventionNames': ['Procedure: Nonsurgical Root canal therapy', 'Device: Dental operating microscope']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Nonsurgical Root canal therapy was performed without any magnification aid in control group.', 'interventionNames': ['Procedure: Nonsurgical Root canal therapy']}], 'interventions': [{'name': 'Nonsurgical Root canal therapy', 'type': 'PROCEDURE', 'description': 'After administration of LA and rubber dam isolation, acess cavity was prepared using carbide burs. Working length was determined using root ZX apex locator and was verified radiographically. Canal preparation was done with protaper gold rotary instruments. 5ml of 5.25% NaOCl was used as irrigant. After instrumentation , the canals were irrigated with 5.0 ml of 17% EDTA for 1minute followed by irrigation with 5.0 ml of 5.25% NaOCl. Canals were dried with absorbent paper points, filled with calcium hydroxide paste and access cavity was restored with IRM.At the recall appointment ; after one week,paste removal, copious irrigation was done with 5.25% NaOCl and canals were dried with paper points. Canals were obturated with Gutta-Percha and ZOE based sealer.', 'armGroupLabels': ['Control group', 'Experimental group']}, {'name': 'Dental operating microscope', 'type': 'DEVICE', 'description': 'Dental operating microscope; a high magnification and illumination device was used in experimental group for performing nonsurgical root canal therapy.', 'armGroupLabels': ['Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '124001', 'city': 'Rohtak', 'state': 'Haryana', 'country': 'India', 'facility': 'Post Graduate Institute of Dental Sciences', 'geoPoint': {'lat': 28.89447, 'lon': 76.58917}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Postgraduate Institute of Dental Sciences Rohtak', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}