Clinical Trial: Pulp Capping With Two Different Agents

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Mineral Trioxide Aggregate (MTA) vs. Calcium Hydroxide (CaOH) in Direct Pulp Capping in NW PRECEDENT (Northwest Practice-based REsearch Collaborative in Evidence-based DENTistry Practices.

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

Detailed Summary:

The purpose of this study was to test two dental products used as direct pulp capping agent for the permanent teeth. The two products were mineral trioxide aggregate and calcium hydroxide.

A direct pulp capping consists of covering an exposed tooth pulp (the inside portion of the tooth where the blood vessels and nerve supply the tooth) with a medication to maintain tooth vitality. Different events can cause the pulp to be exposed, for example a deep cavity, or an accident where the outer portion of the tooth fractures. When this occurs, it is sometimes possible to place a medicine over the top of the exposure (a "cap") in an effort to allow the pulp to heal on its own. Our study intended to compare two of those medicines, calcium hydroxide and mineral trioxide aggregate, both Federal Drug Administration (FDA) approved products, to determine if one performed better than the other.

The study was conducted with patients recruited by Northwest PRECEDENT practitioners. The practitioners interested in participating in the study were randomized (assigned by chance) to one of the two intervention groups: a treatment group (mineral trioxide aggregate) and a control group (calcium hydroxide).

Direct pulp capping was completed on permanent (adult) teeth with pulps exposed due to decay, trauma (injury) or mechanical exposure. Treated teeth were followed over two years to determine how well they responded to the treatment.

All patients who had a pulp exposure of a permanent tooth were eligible for the study. These patients were further asked to participate in the study if they satisfied the inclusion criteria for the study and did not present any of the exclusion criteria stated in the study protocol.

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



Original Primary Outcome: Tooth Survival [ Time Frame: Tooth survival ]

Current Secondary Outcome: Pulp Vitality [ Time Frame: Up to two years ]

No evidence of pulpal resorption or calcification or periradicular radiolucency


Original Secondary Outcome: Pulp Vitality [ Time Frame: 1, 6, 12,18,24 months ]

Information By: Oregon Health and Science University

Dates:
Date Received: December 18, 2008
Date Started: May 2009
Date Completion:
Last Updated: May 3, 2015
Last Verified: May 2015