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Clinical trial

Clinical, Radiographic and Tomographic Evaluation of Apexogenesis With Human Treated Dentin Matrix in Young Permanent Molars

ID
Name
12-3456
Description
Assess the clinical, radiographic, and tomographic outcomes of apexogenesis with human treated dentin matrix in young permanent molars compared to MTA.
Trial arms
Trial start
2022-01-18
Estimated PCD
2022-07-18
Trial end
2023-03-31
Status
Completed
Phase
Early phase I
Treatment
human treated dentin matrix
human treated dentin matrix is compared with mineral trioxide aggregate in apexogenesis
Arms:
human treated dentin matrix
Other names:
human partially demineralized treated dentin matrix
Mineral Trioxide Aggregate
mineral trioxide aggregate was used as control
Arms:
mineral tri oxide aggregate
Other names:
MTA
Size
20
Primary endpoint
clinical outcome
18 months
clinical outcome
18 months
clinical outcome
18 months
radiographic outcomes
18 months
radiographic outcomes
18 months
radiographic outcomes
18 months
tomographic evaluation
18 months
Eligibility criteria
Inclusion Criteria: 1. Bilateral immature permanent mandibular first molars with deep carious lesions. 2. Positive response to pulp testing. 3. Normal radiographic appearance. 4. Healthy children without any systemic disease that interferes with pulp healing. 5. Patient and parent cooperation. Exclusion Criteria: 1. Clinical signs and symptoms of irreversible pulpitis as spontaneous throbbing pain, tenderness to percussion, abnormal tooth mobility, swelling, or sinus tract. 2. Presence of periapical lesion, external or internal root resorption. 3. Carious furcation involvement. 4. Dystrophic calcification of the pulp. 5. Non restorable tooth.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 20, 'type': 'ACTUAL'}}
Updated at
2023-04-26

1 organization

2 products

1 indication

Organization
Nora Mostafa Mohammed Abo Shanady
Product
Human Treated Dentin Matrix
Indication
Dentin Bridge
Product
Mineral Trioxide Aggregate