Overview

This trial is active, not recruiting.

Condition dental pulp exposure
Treatments mineral trioxide aggregate, calcium hydroxide
Sponsor Oregon Health and Science University
Start date May 2009
End date June 2012
Trial size 640 participants
Trial identifier NCT00812877, NIDCR-16752

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Pulp capping agent, Mineral Trioxide Aggregate used as a direct pulp cap
mineral trioxide aggregate MTA
Pulp capping agent, Mineral TrioxideAggregate
(Active Comparator)
Pulp capping agent, Calcium Hydroxide used as a direct pulp cap
calcium hydroxide Calcium Hydroxide
Pulp capping agent, Calcium Hydroxide

Primary Outcomes

Measure
Tooth Survival
time frame: Up to two years

Secondary Outcomes

Measure
Pulp vitality
time frame: Up to two years

Eligibility Criteria

Male or female participants up to 7 years old.

Inclusion Criteria: 1. Any patient less than 7 years old who requires a direct pulp cap of a permanent tooth. 2. The tooth must exhibit a vital pulp upon exposure. 3. The exposure can be due to mechanical, traumatic or carious causes. 4. Patient will be available for the two year follow-up period. Exclusion Criteria: 1. Any primary tooth requiring a direct pulp cap. 2. Tooth demonstrates any radicular radiolucency on a radiograph. 3. Tooth exhibits spontaneous pain. 4. Tooth exhibits lingering (more than 5 seconds) pain to temperature or biting stimulus.

Additional Information

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.
Principal investigator Thomas Hilton, DMD, MS
Description The purpose of this study is to test two dental products used as direct pulp capping agent for the permanent teeth. The two products are 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 intends to compare two of those medicines, calcium hydroxide and mineral trioxide aggregate, both Federal Drug Administration (FDA) approved products, to determine if one performs better than the other. The study will be conducted with patients recruited by NW PRECEDENT practitioners. The practitioners interested in participating in the study will be 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 will be completed on permanent (adult) teeth with pulps exposed due to decay, trauma (injury) or mechanical exposure. Treated teeth will be followed over two years to determine how well they respond to the treatment. All patients who have a pulp exposure of a permanent tooth will be eligible for the study. These patients will be further asked to participate in the study if they satisfy the inclusion criteria for the study and do not present any of the exclusion criteria stated in the study protocol. A tooth to receive a pulp cap will be treated in the following manner: After a tooth pulp has been exposed and the tooth is found to be suitable for a pulp cap, the exposure and surrounding area will be cleaned by gentle rinsing with water. A cotton pellet moistened with 5.25% sodium hypochlorite will be placed over the exposure and allowed to sit for 1-2 minutes. This procedure will be used to control pulp bleeding and remove the germs from that area. After the initial period, the cotton pellet will be removed and the area inspected. If bleeding continues, a new cotton pellet moistened in the sodium hypochlorite solution will be reapplied to the area for an additional several minutes. This will be repeated until bleeding is controlled or the practitioner decides that pulp capping is not appropriate for the situation. Once the bleeding is controlled from the exposure, one of the two pulp capping agents will be applied to the pulp exposure site. Practices will be assigned by chance into one of two treatment groups, those that will complete direct pulp capping with mineral trioxide aggregate and those that will complete direct pulp capping with calcium hydroxide, both FDA approved agents for this purpose. The handling characteristics of the two materials are so different, that it is not practical to blind the practitioners as to which material they are using. Likewise, training in the use of each material will be required. It is believed that it is more important that the practitioner become familiar and competent in the use of one of the materials to ensure it is used appropriately, than it is have practitioners using both materials and confuse procedures between them. Since time is a critical element in the success or failure of direct pulp capping, the patients will be consented to participate in the study after the procedure has been done. A resin-modified glass ionomer liner (e.g. Vitrebond, Fuji Lining Cement, Fuji II LC, Vitremer) will be placed over the pulp capping agent. This liner will seal the pulp capping agent and protect the pulp from being infiltrated with bacteria. After the resin-modified glass ionomer lining material is set, the final filling will be placed. Two types of instruments will be used in this study: Study participant data collection form This form will collect two types of data: demographic and clinical data. The demographic part will gather information regarding patient age, gender, and race. The clinical form will collect data regarding the clinical and x-ray evaluation of the tooth to be treated with a direct pulp cap: condition of the tooth, the type of pulp exposure (by decay, by injury or during tooth preparation), patients' complaints regarding the tooth, and results of diagnosis tests (x-ray, pain to biting or temperature, etc) will be recorded. Practitioner feedback survey A survey will be administered to all practitioners who participate in the study. This survey includes a series of questions designed to evaluate the communication between the member practitioners and the network, practitioner/staff training, patient recruitment, obtaining informed consent, data collection and data transmission, including the electronic data capture system. The survey will also try to determine how well the offices were able to combine the research in a regular daily office schedule in order to determine if a research project will affect the normal day-to-day routine. The intent of this study is to find out which of the two products yields better results as a pulp capping agent. In order to detect this, the failure rates in the two treatment groups will be compared using statistical tests. Distributions of covariates in the two treatment groups will be compared and clinical judgment will be used to identify covariates with serious group imbalances that could cause an unusual result for the primary analysis. Logistic regression will be used to compare failure rates while adjusting for any covariates that are imbalanced between groups.
Trial information was received from ClinicalTrials.gov and was last updated in June 2011.
Information provided to ClinicalTrials.gov by Oregon Health and Science University.