Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2025-12-25 @ 4:40 PM
Study NCT ID:
NCT04763057
Status:
UNKNOWN
Last Update Posted:
2021-02-21
First Post:
2021-02-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Indirect Pulp Treatment in Primary Teeth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002126', 'term': 'Calcium Hydroxide'}], 'ancestors': [{'id': 'D006878', 'term': 'Hydroxides'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017610', 'term': 'Calcium Compounds'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 88}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2022-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-17', 'studyFirstSubmitDate': '2021-02-17', 'studyFirstSubmitQcDate': '2021-02-17', 'lastUpdatePostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical success in term of the absence of post-operative pain', 'timeFrame': 'one year', 'description': 'Visual analog scale'}, {'measure': 'Clinical success in term of the absence of pain on percussion, swelling, sinus, or fistula', 'timeFrame': 'one year', 'description': 'Visual and clinical examinations'}], 'secondaryOutcomes': [{'measure': 'Radiographic success in term of the absence of any adverse radiographic findings (eg. internal or external root resorption or other pathologic changes', 'timeFrame': 'one year', 'description': 'Radiographic examination'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Deep Caries']}, 'descriptionModule': {'briefSummary': 'Conservative approaches such as indirect pulp capping techniques became popular over the last years for the management of deep carious lesions. In particular, indirect pulp-treatment (IPT) techniques have gained remarkable attention in pediatric dentistry, mainly because children require a fast and accurate treatment, besides it enables the affected primary tooth to remain in the mouth until exfoliation without causing any pain or infection.', 'detailedDescription': 'Indirect pulp treatment is recommended for teeth with deep caries approximating the pulp with no signs and symptoms of pulp deterioration. In this treatment, the deepest layer of the remaining carious dentine (affected dentin) is covered with biocompatible material followed by an airtight restoration to achieve a good seal against microleakage, without the need to reencounter for the removal of remaining caries.\n\nCalcium hydroxide has served as a gold standard for IPT over the years. However, the introduction of newer bioactive materials such as mineral trioxide aggregate (MTA) and Biodentine helped surpass the demerits of calcium hydroxide such as internal resorption, nonadherence to dentin, degradation over time, tunnel defects, and poor sealing ability.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Presence of active carious lesions involving either occlusal or proximal surfaces of primary molars.\n\n * Extension of carious lesion such that complete caries removal would risk pulp exposure.\n * History of tolerable dull intermittent pain, mild discomfort associated with eating, negative history of spontaneous extreme pain.\n * Radiographically, carious lesion involving more than 2/3rd thickness of dentin approximating the pulp, normal lamina dura, normal periodontal ligament space, more than 2/3rd of root present, no periapical changes, no pathologic external or internal resorption.\n\nExclusion Criteria:\n\n* • History of spontaneous sharp, penetrating pain, or tenderness on percussion\n\n * Presence of tooth mobility, discoloration, sinus opening, or abscessed tooth.\n * Radiographically, presence of interrupted or broken lamina dura, widened periodontal ligament space, periapical radiolucency, internal or external resorption.\n * Pulp exposure during caries removal.\n * Parental refusal for participation.'}, 'identificationModule': {'nctId': 'NCT04763057', 'briefTitle': 'Indirect Pulp Treatment in Primary Teeth', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Calcium Hydroxide Versus NeoPUTTY MTA in Indirect Pulp Treatment of Primary Molars: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'vital pulp treatment'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'indirect pulp treatment with NeoPUTTY MTA', 'interventionNames': ['Drug: NeoPUTTY MTA']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'indirect pulp treatment with calcium hydroxide', 'interventionNames': ['Drug: calcium hydroxide']}], 'interventions': [{'name': 'NeoPUTTY MTA', 'type': 'DRUG', 'description': 'NeoPUTTY, a premixed bioactive bioceramic MTA that triggers hydroxyapatite and supports healing', 'armGroupLabels': ['indirect pulp treatment with NeoPUTTY MTA']}, {'name': 'calcium hydroxide', 'type': 'DRUG', 'description': 'Calcium hydroxide the gold standard for IPT', 'armGroupLabels': ['indirect pulp treatment with calcium hydroxide']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'marwa aly elchaghaby, phd', 'role': 'CONTACT', 'email': 'marwaaly2003@yahoo.com', 'phone': '01006231612'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Pediatric Dentistry and Dental public health, Faculty of Dentistry, Cairo University, Egypt.', 'investigatorFullName': 'marwa aly fouad elchaghaby', 'investigatorAffiliation': 'Cairo University'}}}}