Ignite Creation Date:
2024-05-05 @ 10:57 PM
Last Modification Date:
2024-10-26 @ 10:26 AM
Study NCT ID:
NCT01224925
Status:
COMPLETED
Last Update Posted:
2019-03-18
First Post:
2010-10-18
Brief Title:
RCT of Pulp Capping Over Carious Exposure in Adults
Sponsor:
University of Tromso
Organization:
University of Tromso
Study Overview
Official Title:
Randomized Controlled Trial of Pulp Capping Over Carious Exposures Comparing MTA With Dycal
Status:
COMPLETED
Status Verified Date:
2018-12
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:
None
Brief Summary:
This multicentre study was a randomized controlled parallel patient-blinded two-arm superiority trial with a 11 allocation ratio that followed the CONSORT guidelinesThe aim of this study was to investigate whether MTA is more effective than a conventional calcium hydroxide liner Dycal as a direct pulp capping material in mature molar teeth with a carious pulpal exposure
Detailed Description:
Calcium hydroxide CH is considered the standard material for pulp capping with good results in cases with pulpal exposure as a result of dental trauma both in animal and clinical studies However in carious exposures follow-up studies of direct pulp capping performed with CH based materials have shown increasing failure rates and the outcome has been considered uncertain Direct capping of carious exposures still remains a controversial treatment for mature teeth
A new material mineral trioxide aggregate MTA was introduced for root end filling material almost two decades ago It is also suggested for pulp capping MTA cement has showed good sealing ability and bio-compatibility in animal studies Results from studies in humans corroborate the results from animal studies
Although the overall results of pulp capping in human studies using MTA are very positive well designed and controlled clinical studies especially involving carious exposures on adult teeth are lackingAt the time the present study was launched there were no RCTs comparing MTA and CH as DPC materials and the histological evaluations have primarily been based on healthy teeth thus undermining the generalizability of the results to adult patients with carious exposures
A new material mineral trioxide aggregate MTA was introduced for root end filling material almost two decades ago It is also suggested for pulp capping MTA cement has showed good sealing ability and bio-compatibility in animal studies Results from studies in humans corroborate the results from animal studies
Although the overall results of pulp capping in human studies using MTA are very positive well designed and controlled clinical studies especially involving carious exposures on adult teeth are lackingAt the time the present study was launched there were no RCTs comparing MTA and CH as DPC materials and the histological evaluations have primarily been based on healthy teeth thus undermining the generalizability of the results to adult patients with carious exposures
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