Prospective Comparison of Indirect Pulp Therapy and Mineral Trioxide Aggregate Pulpotomy in Decayed Primary Molars

Dental Pulp Capping Clinical Trial

Official title:

Prospective Comparison of Indirect Pulp Therapy and Mineral Trioxide Aggregate Pulpotomy in Decayed Primary Molars

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02620826
• Other study ID #: 00077025
• Status: Completed
• Phase: N/A
• Start date: December 2013
• Est. completion date: December 2019

Study information

• Verified date: February 2024
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

Inclusion Criteria:

• Child with at least one primary molar with deep decay approaching the pulp.

Related Conditions & MeSH terms

• Dental Pulp Capping

Intervention

Procedure:
• Indirect pulp therapy
Decayed dentin is lined with a resin-modified glass ionomer (Vitrebond Plus)
• Pulpotomy
A cervical pulpotomy is done and the radicular pulp is lined with Mineral Trioxide Aggregate

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical assessment of pulp vitality	Pain, mobility, abscess as determined with clinical evaluation	10 years
Secondary	Radiographic assessment of pulp vitality	Signs of pulpal degeneration, including evaluation for presence or absence of internal/external root resorption, periodontal ligament widening, and intraradicular radiolucency as determined with radiographic evaluation	10 years