This trial is active, not recruiting.

Condition dental pulp capping
Treatments indirect pulp therapy, pulpotomy
Sponsor University of Michigan
Start date December 2013
End date December 2023
Trial size 400 participants
Trial identifier NCT02620826, 00077025


This prospective study compares the use of indirect pulp therapy and mineral trioxide aggregate pulpotomy for pulp therapy of the primary molar with dental caries approaching the pulp.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Primary molars will be treated with indirect pulp therapy using resin-modified glass ionomer (Vitrebond Plus).
indirect pulp therapy
Decayed dentin is lined with a resin-modified glass ionomer (Vitrebond Plus)
(Active Comparator)
Primary molars treated with MTA pulpotomy.
A cervical pulpotomy is done and the radicular pulp is lined with Mineral Trioxide Aggregate

Primary Outcomes

Clinical assessment of pulp vitality
time frame: 10 years

Secondary Outcomes

Radiographic assessment of pulp vitality
time frame: 10 years

Eligibility Criteria

Male or female participants from 2 years up to 12 years old.

Inclusion Criteria: - Child with at least one primary molar with deep decay approaching the pulp.

Additional Information

Official title Prospective Comparison of Indirect Pulp Therapy and Mineral Trioxide Aggregate Pulpotomy in Decayed Primary Molars
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by University of Michigan.