Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-30 @ 3:57 AM
Study NCT ID:
NCT07437794
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical and Radiographic Assessment of Neo Putty MTA Versus Formocresol Used in Vital Pulpotomy of Mandibular Primary Molars
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'C031025', 'term': 'formocresol'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'the statistician will be blinded'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 68}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-23', 'studyFirstSubmitDate': '2026-02-23', 'studyFirstSubmitQcDate': '2026-02-23', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative pain', 'timeFrame': '1 week postoperatively, 3 months, 6 months, 9 months and 12 months', 'description': 'Presence or absence of spontaneous postoperative pain reported by the child/parent after pulpotomy treatment.'}], 'secondaryOutcomes': [{'measure': 'Pain on percussion', 'timeFrame': '3 months, 6 months, 9 months and 12 months', 'description': 'Description: Presence or absence of pain on percussion during clinical follow-up visits.'}, {'measure': 'Presence of sinus tract, fistula or abscess', 'timeFrame': '3 months, 6 months, 9 months and 12 months', 'description': 'Description: Clinical evaluation for presence of swelling, abscess, or sinus/fistulous tract related to the treated tooth.'}, {'measure': 'Tooth mobility', 'timeFrame': '3 months, 6 months, 9 months and 12 months', 'description': 'Description: Tooth mobility assessed clinically using a mobility scoring system ranges from 0-3 were (score 0 the best) indicates no mobility and (score 3 the worst) indicates vertical and horizontal mobility.'}, {'measure': 'Widening of Periodontal Ligament Space', 'timeFrame': '6 months and 12 months after treatment', 'description': 'Radiographic evidence of widening of the periodontal ligament space assessed using standardized periapical radiographs. Recorded as Present / Absent.'}, {'measure': 'Internal and External Root Resorption', 'timeFrame': '6 months and 12 months after treatment', 'description': 'Radiographic evidence of internal or external root resorption observed on periapical radiographs. Recorded as Present / Absent.'}, {'measure': 'Furcal or Periapical Radiolucency', 'timeFrame': '6 months and 12 months after treatment', 'description': 'Presence of radiolucent lesion in the furcation or periapical area detected on standardized periapical radiographs. Recorded as Present / Absent.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Deep Caries in Primary Molars', 'NeoPutty MTA', 'Mineral Trioxide Aggregate', 'Formocresol', 'Vital Pulp Therapy', 'Pulpotomy', 'Stainless Steel Crown'], 'conditions': ['Deep Caries in Primary Molars']}, 'descriptionModule': {'briefSummary': 'This randomized clinical trial aims to evaluate the clinical and radiographic success of NeoPutty MTA compared to formocresol in vital pulpotomy of mandibular primary molars in children aged 4 to 9 years. Participants will be randomly allocated into two groups (1:1) to receive pulpotomy using either NeoPutty MTA or formocresol, followed by restoration with stainless steel crowns. Clinical and radiographic outcomes will be assessed during follow-up visits.', 'detailedDescription': 'Pulpotomy is a commonly performed vital pulp therapy in pediatric dentistry. Formocresol has been widely used due to its high clinical success; however, concerns exist regarding its potential toxicity. NeoPutty MTA is a premixed bioceramic material introduced as an alternative pulpotomy agent with improved handling properties and bioactivity. This randomized parallel-group clinical trial will compare NeoPutty MTA versus formocresol in vital pulpotomy of mandibular primary molars. Children aged 4-9 years presenting with asymptomatic carious mandibular primary molars will be recruited from the Pediatric Dentistry Department, Faculty of Dentistry, MSA University. Eligible teeth will undergo standardized pulpotomy procedures, restoration with glass ionomer cement, and stainless steel crowns. Clinical and radiographic follow-up will be performed at scheduled intervals to evaluate success and failure outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nChildren with asymptomatic decayed primary mandibular molar(s).\n\n* Patient and parent showing cooperation and compliance.\n* Children 4-9 years old.\n* Vital carious primary(s) with complete root formation.\n* Asymptomatic teeth or without clinical symptoms of spontaneous pain.\n* No clinical evidence of pulp degeneration like the history of spontaneous or nocturnal pain, tenderness to percussion, pathologic tooth mobility, swelling, or fistulous tract.\n* Both genders will be included.\n* No radiographic evidence of pulp degeneration such as internal root resorption, external root resorption, or furcal radiolucency.\n* Presence of two thirds of the root.\n* Teeth that can be restored.\n* Children with prior parental consent.\n\nExclusion Criteria:\n\n* History of any systemic disease.\n* Hemostasis is not achieved within 5 minutes of pulp amputation, by direct contact with a wet cotton pellet before the material placement.\n* The remaining radicular tissue was non-vital (with suppuration or purulence necrosis).'}, 'identificationModule': {'nctId': 'NCT07437794', 'briefTitle': 'Clinical and Radiographic Assessment of Neo Putty MTA Versus Formocresol Used in Vital Pulpotomy of Mandibular Primary Molars', 'organization': {'class': 'OTHER', 'fullName': 'October University for Modern Sciences and Arts'}, 'officialTitle': 'Clinical and Radiographic Assessment of Neo Putty MTA Versus Formocresol Used in Vital Pulpotomy of Mandibular Primary Molars: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'Ahmed MSA University'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A: NeoPutty MTA Pulpotomy', 'description': 'Participants will receive vital pulpotomy of mandibular primary molars using NeoPutty MTA as the pulpotomy medicament, followed by restoration with glass ionomer cement and stainless steel crown.', 'interventionNames': ['Drug: NeoPutty MTA']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm B: Formocresol Pulpotomy', 'description': "Participants will receive vital pulpotomy of mandibular primary molars using formocresol (1:5 dilution of Buckley's formocresol) applied with cotton pellet, followed by reinforced zinc oxide eugenol, glass ionomer cement, and stainless steel crown.", 'interventionNames': ['Drug: Formocresol']}], 'interventions': [{'name': 'NeoPutty MTA', 'type': 'DRUG', 'description': 'NeoPutty MTA (NuSmile) will be placed directly over the radicular pulp stumps after hemostasis, then the tooth will be sealed with resin-modified glass ionomer cement and restored with stainless steel crown.', 'armGroupLabels': ['Arm A: NeoPutty MTA Pulpotomy']}, {'name': 'Formocresol', 'type': 'DRUG', 'description': "A sterile cotton pellet lightly moistened with a 1:5 dilution of Buckley's formocresol will be placed against the pulp stumps for 3-5 minutes, then removed. Reinforced zinc oxide eugenol will be placed, followed by glass ionomer cement and stainless steel crown restoration.", 'armGroupLabels': ['Arm B: Formocresol Pulpotomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12116', 'city': 'Giza', 'state': 'Giza Governorate', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed Shawky', 'role': 'CONTACT', 'email': 'ahmed.shawky3@msa.edu.eg', 'phone': '+201124465202'}], 'facility': 'October university for modern sciences and arts', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'centralContacts': [{'name': 'Ahmed Shawky, bachelor of dentistry', 'role': 'CONTACT', 'email': 'ahmed.shawky3@msa.edu.eg', 'phone': '+201124465202'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'October University for Modern Sciences and Arts', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'general practitioner at ministry of health in Egypt', 'investigatorFullName': 'Ahmed Shawky Amer', 'investigatorAffiliation': 'October University for Modern Sciences and Arts'}}}}