NCT02620826

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2015

Completed
10 months until next milestone

First Posted

Study publicly available on registry

December 3, 2015

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

February 6, 2024

Status Verified

February 1, 2024

Enrollment Period

6 years

First QC Date

January 28, 2015

Last Update Submit

February 4, 2024

Conditions

Dental Pulp Capping

Outcome Measures

Primary Outcomes (1)

  • Clinical assessment of pulp vitality

    Pain, mobility, abscess as determined with clinical evaluation

    10 years

Secondary Outcomes (1)

  • Radiographic assessment of pulp vitality

    10 years

Study Arms (2)

Indirect pulp therapy

EXPERIMENTAL

Primary molars will be treated with indirect pulp therapy using resin-modified glass ionomer (Vitrebond Plus).

Procedure: Indirect pulp therapy

Pulpotomy

ACTIVE COMPARATOR

Primary molars treated with MTA pulpotomy.

Procedure: Pulpotomy

Interventions

Indirect pulp therapyPROCEDURE

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

Indirect pulp therapy
PulpotomyPROCEDURE

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

Pulpotomy

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Interventions

Pulpotomy

Intervention Hierarchy (Ancestors)

EndodonticsDentistry

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

January 28, 2015

First Posted

December 3, 2015

Study Start

December 1, 2013

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

February 6, 2024

Record last verified: 2024-02

Locations

US(1)