Clinical trial
Tomographic Evaluation of Pulpotomy in Young Permanent Teeth Using Human-treated Dentin Matrix Versus Mineral Trioxide Aggregate
Name
11-21
Description
Assess tomographic outcomes of pulpotomy in young permanent molars using human-treated dentin matrix versus MTA.
Trial arms
Trial start
2022-01-18
Estimated PCD
2023-06-18
Trial end
2023-10-18
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 Tri-Oxide Aggregate
mineral trioxide aggregate was used as control
Arms:
mineral tri oxide aggregate
Size
20
Primary endpoint
clinical outcomes
18 months
Tomographic outcomes
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
2023-11-03
1 organization
2 products
1 indication
Organization
Tanta UniversityProduct
Human Treated Dentin MatrixIndication
PulpotomyProduct
Mineral Tri-Oxide Aggregate