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Completed

NCT Number: NCT02620826

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

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.

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Key information

Conditions

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Indirect pulp therapy

Procedure

Decayed dentin is lined with a resin-modified glass ionomer (Vitrebond Plus)

Pulpotomy

Procedure

A cervical pulpotomy is done and the radicular pulp is lined with Mineral Trioxide Aggregate

Primary outcomes

  1. Clinical assessment of pulp vitality

    Time frame: 10 years

    Pain, mobility, abscess as determined with clinical evaluation

Secondary outcomes

  1. Radiographic assessment of pulp vitality

    Time frame: 10 years

    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

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Dec 3, 2015
Registry last updated
Feb 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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