Ignite Creation Date:
2024-05-05 @ 9:08 PM
Last Modification Date:
2024-10-26 @ 9:59 AM
Study NCT ID:
NCT00812877
Status:
COMPLETED
Last Update Posted:
2015-05-25
First Post:
2008-12-18
Brief Title:
Pulp Capping With Two Different Agents
Sponsor:
Oregon Health and Science University
Organization:
Oregon Health and Science University
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MTA
Brief Summary:
The purpose of this study is to determine if MTA or calcium hydroxide are more effective as pulp capping agents
Detailed Description:
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
A tooth that received a pulp cap was treated in the following manner After a tooth pulp had been exposed and the tooth was found to be suitable for a pulp cap the exposure and surrounding area was cleaned by gentle rinsing with water A cotton pellet moistened with 525 sodium hypochlorite was placed over the exposure and allowed to sit for 1-2 minutes This procedure was used to control pulp bleeding and remove the germs from that area After the initial period the cotton pellet was removed and the area inspected If bleeding continued a new cotton pellet moistened in the sodium hypochlorite solution was reapplied to the area for an additional several minutes This was repeated until bleeding was controlled or the practitioner decided that pulp capping was not appropriate for the situation Once the bleeding was controlled from the exposure one of the two pulp capping agents was applied to the pulp exposure site
Practices were assigned by chance into one of two treatment groups those that completed direct pulp capping with mineral trioxide aggregate and those that completed direct pulp capping with calcium hydroxide both FDA approved agents for this purpose The handling characteristics of the two materials were so different that it was not practical to blind the practitioners as to which material they were using Likewise training in the use of each material was required It was believed that it was more important that the practitioner become familiar and competent in the use of one of the materials to ensure it was used appropriately than it was to have practitioners use both materials and confuse procedures between them Since time was a critical element in the success or failure of direct pulp capping the patients were consented to participate in the study after the procedure was done A resin-modified glass ionomer liner eg Vitrebond Fuji Lining Cement Fuji II LC Vitremer was placed over the pulp capping agent This liner sealed the pulp capping agent and protected the pulp from being infiltrated with bacteria After the resin-modified glass ionomer lining material was set the final filling was placed
Two types of instruments were used in this study
Study participant data collection form This form collected two types of data demographic and clinical data The demographic part gathered information regarding patient age gender and race The clinical form collected data regarding the clinical and x-ray evaluation of the tooth 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 diagnostic tests x-ray pain to biting or temperature etc were recorded
Practitioner feedback survey A survey was administered to all practitioners who participated in the study This survey included a series of questions designed to evaluate the communication between the member practitioners and the network practitionerstaff training patient recruitment obtaining informed consent data collection and data transmission including the electronic data capture system The survey also tried 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 would affect the normal day-to-day routine
The intent of this study was to find out which of the two products yielded better results as a pulp capping agent In order to detect this the failure rates in the two treatment groups were compared using statistical tests Distributions of covariates in the two treatment groups were compared and clinical judgment was used to identify covariates with serious group imbalances that would cause an unusual result for the primary analysis Logistic regression was used to compare failure rates while adjusting for any covariates that were imbalanced between groups
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
A tooth that received a pulp cap was treated in the following manner After a tooth pulp had been exposed and the tooth was found to be suitable for a pulp cap the exposure and surrounding area was cleaned by gentle rinsing with water A cotton pellet moistened with 525 sodium hypochlorite was placed over the exposure and allowed to sit for 1-2 minutes This procedure was used to control pulp bleeding and remove the germs from that area After the initial period the cotton pellet was removed and the area inspected If bleeding continued a new cotton pellet moistened in the sodium hypochlorite solution was reapplied to the area for an additional several minutes This was repeated until bleeding was controlled or the practitioner decided that pulp capping was not appropriate for the situation Once the bleeding was controlled from the exposure one of the two pulp capping agents was applied to the pulp exposure site
Practices were assigned by chance into one of two treatment groups those that completed direct pulp capping with mineral trioxide aggregate and those that completed direct pulp capping with calcium hydroxide both FDA approved agents for this purpose The handling characteristics of the two materials were so different that it was not practical to blind the practitioners as to which material they were using Likewise training in the use of each material was required It was believed that it was more important that the practitioner become familiar and competent in the use of one of the materials to ensure it was used appropriately than it was to have practitioners use both materials and confuse procedures between them Since time was a critical element in the success or failure of direct pulp capping the patients were consented to participate in the study after the procedure was done A resin-modified glass ionomer liner eg Vitrebond Fuji Lining Cement Fuji II LC Vitremer was placed over the pulp capping agent This liner sealed the pulp capping agent and protected the pulp from being infiltrated with bacteria After the resin-modified glass ionomer lining material was set the final filling was placed
Two types of instruments were used in this study
Study participant data collection form This form collected two types of data demographic and clinical data The demographic part gathered information regarding patient age gender and race The clinical form collected data regarding the clinical and x-ray evaluation of the tooth 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 diagnostic tests x-ray pain to biting or temperature etc were recorded
Practitioner feedback survey A survey was administered to all practitioners who participated in the study This survey included a series of questions designed to evaluate the communication between the member practitioners and the network practitionerstaff training patient recruitment obtaining informed consent data collection and data transmission including the electronic data capture system The survey also tried 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 would affect the normal day-to-day routine
The intent of this study was to find out which of the two products yielded better results as a pulp capping agent In order to detect this the failure rates in the two treatment groups were compared using statistical tests Distributions of covariates in the two treatment groups were compared and clinical judgment was used to identify covariates with serious group imbalances that would cause an unusual result for the primary analysis Logistic regression was used to compare failure rates while adjusting for any covariates that were imbalanced between groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01DE016750 | NIH | None | httpsreporternihgovquickSearchU01DE016750 |