Clinical trial

Evaluation of MTA Pulpotomy, Biodentine Pulpotomy, and Glass Ionomer Indirect Pulp Treatment in Primary Teeth

Name
HP-00058711
Description
In primary teeth, decay that is near the pulp (tooth nerve)is treated with either a pulpotomy or indirect pulp treatment if the tooth is not going to be extracted A pulpotomy involves removing the top 1/2 of the pulp, placing a medication/material on the pulp, covering the remaining pulp with a cement, and the restoring the tooth. The purpose of this pilot study is to gain preliminary information regarding the success of Biodentine, MTA, and IPT in the treatment of deep decay in children's primary molars.
Trial arms
Trial start
2018-07-01
Estimated PCD
2025-02-01
Trial end
2025-02-01
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Mineral Trioxide Aggregate
Vital pulp therapy
Arms:
MTA pulpotomy
Other names:
MTA pulpotomy
Biodentin
Vital pulp therapy
Arms:
Biodentin pulpotomy
Other names:
Biodentin Pulpotomy
Vitrebond
Vital pulp therapy
Arms:
Indirect pulp cap
Other names:
Indirect pulp cap
Size
76
Primary endpoint
Clinical success after pulpotomy
3 years
Clinical success after indirect pulp cap
3 years
Radiographic success after pulpotomy
3 years
Eligibility criteria
Inclusion Criteria: * Pediatric patients with deep dental decay in primary molars * Teeth with signs and symptoms of reversible pulpitis Exclusion Criteria: * Teeth with clinical symptoms of irriversible pulpitis or pulp necrosis or acute dental infection * Children with systemic illness that contraindicated vital pulp treatment such a sickle cell disease * Teeth that are not restorable
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 76, 'type': 'ESTIMATED'}}
Updated at
2024-02-26

1 organization

2 products

3 indications

Indication
Pulpotomy
Product
Biodentin