Clinical trial

Clinical and Radiographic Evaluation of 3Mixtatin Versus MTA Used as Pulpotomy Agents in Vital Primary Molars: A Randomized Clinical Trial

Name
3Mixtatin and MTA pulpotomy
Description
The aim of the study is to evaluate clinical and radiographic success of using 3Mixtain versus mineral trioxide aggregate in pulpotomy of deeply carious Primary molars.
Trial arms
Trial start
2024-08-01
Estimated PCD
2025-08-01
Trial end
2025-09-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
3 mixtatin pulpotomy
pulp treatment with applying 3mixture of antibiotic (Metronidazole, cefixime, and Ciprofloxacin) along with simvastatin
Arms:
3 Mixtatin pulpotomy
MTA pulpotomy
pulp treatment with applying MTA
Arms:
MTA pulpotomy
Size
50
Primary endpoint
Clinical success Clinical success clinical success
1 week , 3 months , 6 months , 9 months and 12 months
Eligibility criteria
Inclusion Criteria: * • Children 4-8 years old * Vital deeply carious primary molars. * No history of spontaneous pain, pathologic mobility, draining sinus tract, redness or swelling of the vestibule. * Normal gingival and periodontal condition, with no sensitivity to vestibular palpation, and no pain on percussion test. * Patient and parent showing cooperation and compliance. Exclusion Criteria: * • Uncooperative children to avoid time waste and attrition bias. * Unrestorable molars * Sign of radiolucency in periapical or furcation area * Widening of PDL space or loss of lamina dura continuity * Evidence of internal/external pathologic root resorption * During operative procedure, when hemorrhage control is not achievable after pulpotomy. * Children with systemic disease as some systemic diseases may have effect on the outcome. * Unable to attend follow-up visits to avoid attrition bias by decreasing number of drop off cases. * Refusal of participation as the parent of child has the authority of participation.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}
Updated at
2024-06-27

1 organization

2 products

3 indications

Organization
Cairo University
Product
Mixtatin
Indication
Pulp Disease
Indication
Toothache
Indication
Primary Teeth