NCT00812877

Brief Summary

The purpose of this study is to determine if MTA or calcium hydroxide are more effective as pulp capping agents

Trial Health

87
On Track

Trial Health Score

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

Enrollment
376

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2009

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 22, 2008

Completed
4 months until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

May 25, 2015

Completed
Last Updated

May 25, 2015

Status Verified

May 1, 2015

Enrollment Period

3 years

First QC Date

December 18, 2008

Results QC Date

August 15, 2013

Last Update Submit

May 3, 2015

Conditions

Dental Pulp Exposure

Keywords

pulp cappingMTACaOHMineral Trioxide AggregateCalcium Hydroxide

Outcome Measures

Primary Outcomes (1)

  • Tooth Survival

    No recommendation for tooth extraction or root canal therapy. Only one tooth was enrolled/assessed per participant.

    Up to two years

Secondary Outcomes (1)

  • Pulp Vitality

    Up to two years

Study Arms (2)

Mineral Trioxide Aggregate

ACTIVE COMPARATOR

Pulp capping agent, Mineral Trioxide Aggregate used as a direct pulp cap

Drug: Mineral Trioxide Aggregate

Calcium Hydroxide

ACTIVE COMPARATOR

Pulp capping agent, Calcium Hydroxide used as a direct pulp cap

Drug: Calcium Hydroxide

Interventions

Mineral Trioxide AggregateDRUG

Pulp capping agent, Mineral TrioxideAggregate

Also known as: MTA
Mineral Trioxide Aggregate
Calcium HydroxideDRUG

Pulp capping agent, Calcium Hydroxide

Calcium Hydroxide

Eligibility Criteria

Age7 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Any patient 7 years old or older who requires a direct pulp cap of a permanent tooth.
  • The tooth must exhibit a vital pulp upon exposure.
  • The exposure can be due to mechanical, traumatic or carious causes.
  • Patient will be available for the two year follow-up period.

You may not qualify if:

  • Any primary tooth requiring a direct pulp cap.
  • Tooth demonstrates any radicular radiolucency on a radiograph.
  • Tooth exhibits spontaneous pain.
  • Tooth exhibits lingering (more than 5 seconds) pain to temperature or biting stimulus.
  • Non-English and/or non-Spanish speaking subjects.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (2)

  • Hilton TJ. Keys to clinical success with pulp capping: a review of the literature. Oper Dent. 2009 Sep-Oct;34(5):615-25. doi: 10.2341/09-132-0. No abstract available.

    PMID: 19830978BACKGROUND

  • Hilton TJ, Ferracane JL, Mancl L; Northwest Practice-based Research Collaborative in Evidence-based Dentistry (NWP). Comparison of CaOH with MTA for direct pulp capping: a PBRN randomized clinical trial. J Dent Res. 2013 Jul;92(7 Suppl):16S-22S. doi: 10.1177/0022034513484336. Epub 2013 May 20.

    PMID: 23690353RESULT

MeSH Terms

Conditions

Dental Pulp Exposure

Interventions

mineral trioxide aggregatePemetrexedCalcium Hydroxide

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

GuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DicarboxylicHydroxidesAlkaliesInorganic ChemicalsCalcium CompoundsAnionsIonsElectrolytes

Limitations and Caveats

1. Randomization was by practice therefore, some dentists may have used a material with which they had little familiarity. 2. Lack of on-going monitoring of study procedures may have caused an inordinate number of failures in one practice.

Results Point of Contact

Title
Dr. Thomas J. Hilton
Organization
Oregon Health & Science University
hiltont@ohsu.edu
503.494.8672

Study Officials

  • Thomas Hilton, DMD, MS

    NW PRECEDENT

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 18, 2008

First Posted

December 22, 2008

Study Start

May 1, 2009

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

May 25, 2015

Results First Posted

May 25, 2015

Record last verified: 2015-05

Locations

US(1)