Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:21 AM
Study NCT ID:
NCT04394702
Status:
COMPLETED
Last Update Posted:
2020-05-19
First Post:
2020-05-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Single-file Pulpectomy in Primary Molars
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003790', 'term': 'Dental Pulp Necrosis'}], 'ancestors': [{'id': 'D003788', 'term': 'Dental Pulp Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-03-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-14', 'studyFirstSubmitDate': '2020-05-10', 'studyFirstSubmitQcDate': '2020-05-14', 'lastUpdatePostDateStruct': {'date': '2020-05-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain presence or absence', 'timeFrame': 'one year', 'description': 'score 0 was applied for absence of pain and score 1 was applied for presence of pain'}, {'measure': 'swelling presence or absence', 'timeFrame': 'one year', 'description': 'score 0 was applied for absence of swelling and score 1 was applied for presence of swelling'}, {'measure': 'radiographic success or failure', 'timeFrame': 'one year', 'description': 'it was done using periapical radiograph and score 0 was applied for absence of radiolucency and score 1 was applied for presence of radiolucency'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pulpectomy', 'Pediatric Dentistry'], 'conditions': ['Pulpal Necrosis']}, 'descriptionModule': {'briefSummary': 'The current study evaluates the rotational One Shape single-file system regarding clinical and radiographic outcomes in root canal treatment of infected primary molars.\n\nThis randomized clinical trial was carried out on 94 primary molars on children in the age group from 4 to 6 years. The teeth selected for this study were randomly assigned into 2 groups according to the used endodontic preparation system. Group I: 47 primary molars were instrumented with One Shape rotational single-file system. Group II: 47 primary molars were instrumented with stainless steel K-files. All teeth were evaluated clinically and radigraphically for 12 months with periodic recall at 3, 6 and 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children categorized as class I or II according to American Society of Anesthesiologists (ASA).\n* Children aged between 4 and 6 years with at least one necrotic primary second mandibular molar.\n* History of dull toothache over an extended period of time\n* History of spontaneous pain or pain at night\n* Swelling adjacent to tooth with or without a sinus tract\n* Abnormal tooth mobility\n* Presence of necrotic pulp tissue or purulent discharge when the pulp chamber was accessed\n* Interruption of lamina dura or thickening of periodontal ligament space\n* Furcational radiolucency did not surpass half of the distance between the furcation and permanent successor\n* Negative findings of internal root resorption\n* External root resorption confined to the apical third and with at least two-thirds of the root length was intact\n\nExclusion Criteria:\n\n* Uncoperative children or parents/legal guardians\n* Sever intellectual, behaviour or emotional problems\n* Non-restorable tooth crowns\n* Root canal obliteration\n* Presence of underlying dentigerous or follicular cysts'}, 'identificationModule': {'nctId': 'NCT04394702', 'briefTitle': 'Single-file Pulpectomy in Primary Molars', 'organization': {'class': 'OTHER', 'fullName': 'Minia University'}, 'officialTitle': 'Efficacy of One-Shape Single-file System in Pulpectomy of Infected Primary Molars: In-vitro and In-vivo Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': '42/183/11/2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'One Shape Single-file rotary system', 'interventionNames': ['Other: One Shape Single-file rotary system']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Manual stainless steel K-file', 'interventionNames': ['Other: manual stainless steel K-file']}], 'interventions': [{'name': 'One Shape Single-file rotary system', 'type': 'OTHER', 'description': 'rotational single file system used for mechanical debridement of root canals', 'armGroupLabels': ['One Shape Single-file rotary system']}, {'name': 'manual stainless steel K-file', 'type': 'OTHER', 'description': 'sequential manual filing with stainless steel K-files', 'armGroupLabels': ['Manual stainless steel K-file']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61517', 'city': 'Minya', 'country': 'Egypt', 'facility': 'Minia University, Faculty of Dentistry.', 'geoPoint': {'lat': 28.09193, 'lon': 30.75813}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant lecturer', 'investigatorFullName': 'Osama Seif El-Nasr Hussein Gad El-Hak', 'investigatorAffiliation': 'Minia University'}}}}