Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-24 @ 6:37 PM
Study NCT ID:
NCT03833557
Status:
COMPLETED
Last Update Posted:
2020-04-06
First Post:
2019-01-30
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Success Rate of Three Capping Materials
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2019-01-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-02', 'studyFirstSubmitDate': '2019-01-30', 'studyFirstSubmitQcDate': '2019-02-05', 'lastUpdatePostDateStruct': {'date': '2020-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical success rate', 'timeFrame': '12 Month', 'description': 'abscence of all clinical signs and symptoms of failure'}], 'secondaryOutcomes': [{'measure': 'Radiographic success rate', 'timeFrame': '12 Month', 'description': 'Absence of any radiographic signs of failure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Formocresol', 'MTA', 'Nanohydroxyapatite', 'Pulpotomy'], 'conditions': ['Caries']}, 'referencesModule': {'references': [{'pmid': '34803301', 'type': 'DERIVED', 'citation': 'Abd Al Gawad RY, Hanafy RMH. Success rate of three capping materials used in pulpotomy of primary molars: A randomized clinical trial. Saudi Dent J. 2021 Nov;33(7):560-567. doi: 10.1016/j.sdentj.2020.08.007. Epub 2020 Aug 29.'}]}, 'descriptionModule': {'briefSummary': 'A randomized clinical trial was carried out on 72 second primary molars indicated for pulpotomy divided into three equal groups (n=24) . First group received Nanohydroxyapatite as a pulpotomy agent , second group received Mineral Trioxide Aggregate ( MTA) \\& the third received Formocresol pulpotomy. All pulpotomized teeth were finally restored with stainless steel crowns. Subjects were monitored clinically and radiographically at one, three , six \\& 12 months.', 'detailedDescription': "The study population included four to eight years old healthy and cooperative patients who presented at the Pediatric Dental Clinic, Faculty of Dentistry, Cairo University with mandibular second primary molars indicated for pulpotomy which met specific inclusion and exclusion criteria. Written consent was obtained from the parent/guardian after explaining the full details of the treatment procedure.\n\nProcedures:\n\nPreoperative periapical radiograph using periapical film size two Speed D Film , was taken for the molars considered for treatment. Radiographs should be of proper film density and contrast for proper radiographic diagnosis.\n\nThe pulpotomy procedure was performed by the same operator. Local anesthesia was induced and rubber dam isolation was performed, followed by caries removal and deroofing of the pulp chamber using a #330 high-speed carbide bur mounted in a water-cooled high speed turbine. The coronal pulp tissue was amputated using a sterile sharp spoon excavator. The pulp chamber was irrigated with physiologic saline. Pulp homeostasis was achieved using a sterile wet cotton pellet applied for two to three min.\n\nIn Group 1:\n\nFollowing the manufacturer's instructions, Nanohydroxyapatite was mixed with distilled water to homogeneous consistency then introduced into the pulp chamber and condensed properly against the pulp orifices.\n\nIn Group 2:\n\nThe MTA powder was mixed with sterile water in a 3:1 powder/water ratio according to the manufacturer's instructions to obtain a thick creamy paste, then placed on the floor of the pulp chamber using a messing gun and compacted against the pulp orifices with a condenser over a moist cotton pellet.\n\nGroup 3:\n\nA cotton pellet with formocresol was placed on the pulp stumps then removed and ZO/E dressing was condensed against the pulp stumps.\n\nAll Molars were finally restored with stainless steel crowns cemented with GI cement . An immediate postoperative radiograph using periapical film size two was taken.\n\nClinical and radiographic evaluation:\n\nAll treated patients were followed up at one, three , six \\& 12 months after the pulpotomy.\n\nThe pulpotomized teeth were judged as clinically successful if they met the following criteria: Absence of sensitivity, pain, tenderness to percussion, abscess, fistula or tooth mobility. Radiographic success was defined if there were normal periodontal ligament space, absence of furcation or periapical radiolucency, absence of internal or external root resorption\n\nStatistical analysis:\n\nData were collected, revised for completeness and logical consistency, tabulated, and statistically analyzed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Absence of tenderness to percussion.\n\n * Absence of physiologic or pathologic tooth mobility.\n * No clinical evidence of pulpal inflammation or degeneration, such as history of swelling or presence of sinus tract.\n * Restorable teeth.\n * Absence of radiographic evidence of internal or external root resorption, pulpal calcification, or osseous disease (periapical or furcation infection\n\nExclusion Criteria:\n\n* • Evidence of necrosis after access cavity preparation.\n\n * Hemostasis could not be achieved within three min after direct contact with a wet cotton pellet, prior to material placement.'}, 'identificationModule': {'nctId': 'NCT03833557', 'briefTitle': 'Success Rate of Three Capping Materials', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Success Rate of Three Capping Materials Used in Pulpotomy of Primary Molars: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '181053'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Nanohydroxyapatite Pulpotomy', 'description': "Biphasic calcium phosphate. Straumann BoneCeramic Regenerative Pulpotomy of 24 mandibular second primary molars using Nanohydroxyapatite\n\nIn Group 1: 24 mandibular second primary molars Caries removal and deroofing of pulp chamber Following the manufacturer's instructions, Nanohydroxyapatite was mixed with distilled water to homogeneous consistency then introduced into the pulp chamber and condensed properly against the pulp orifices.\n\nAll Molars were finally restored with stainless steel crowns cemented with GI cement . An immediate postoperative radiograph using periapical film size two was taken.\n\nClinical and radiographic evaluation: All treated patients were followed up at one, three , six \\& 12 months after the pulpotomy", 'interventionNames': ['Procedure: Nanohydroxyapatite Pulpotomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MTA Pulpotomy', 'description': "Angelus Grey MTA , Regenerative Pulpotomy Pulpotomy of 24 mandibular second primary molars using MTA Caries removal and deroofing of pulp chamber The MTA powder was mixed with sterile water in a 3:1 powder/water ratio according to the manufacturer's instructions to obtain a thick creamy paste, then placed on the floor of the pulp chamber using a messing gun and compacted against the pulp orifices with a condenser over a moist cotton pellet.\n\nAll Molars were finally restored with stainless steel crowns cemented with GI cement . An immediate postoperative radiograph using periapical film size two was taken.\n\nClinical and radiographic evaluation at one, three ,six \\& 12 months after pulpotomy.", 'interventionNames': ['Procedure: MTA pulpotomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Formocresl Pulpotomy', 'description': "Buckley' s Formocresol , Fixation pulpotomy Pulpotomy of 24 mandibular second primary molars using Formocresol Caries removal and deroofing of pulp chamber\n\nA cotton pellet with formocresol was placed on the pulp stumps then removed and ZO/E dressing was condensed against the pulp stumps.\n\nAll Molars were finally restored with stainless steel crowns cemented with GI cement . An immediate postoperative radiograph using periapical film size two was taken.\n\nClinical and radiographic evaluation: All treated patients were followed up at one, three , six \\& 12 months after the pulpotomy for clinical and radiographic evaluation. Independently, two examiners evaluated the teeth clinically and radiographically.", 'interventionNames': ['Procedure: Formocresol Pulpotomy']}], 'interventions': [{'name': 'Nanohydroxyapatite Pulpotomy', 'type': 'PROCEDURE', 'description': 'Biphasic calcium phosphate 500-1000 Um Straumann BoneCeramic', 'armGroupLabels': ['Nanohydroxyapatite Pulpotomy']}, {'name': 'MTA pulpotomy', 'type': 'PROCEDURE', 'description': 'Angleus grey MTA', 'armGroupLabels': ['MTA Pulpotomy']}, {'name': 'Formocresol Pulpotomy', 'type': 'PROCEDURE', 'description': "Buckley's Fromocresol. diluted full strength foromocresol", 'armGroupLabels': ['Formocresl Pulpotomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '+202', 'city': 'Giza', 'country': 'Egypt', 'facility': 'Randa Youssef', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'ipdSharing': 'YES', 'description': 'Study design and procedures'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Randa Youssef Abd Al Gawad', 'investigatorAffiliation': 'Cairo University'}}}}