RCT of Pulp Capping Over Carious Exposures Comparing Mineral Trioxide Aggregate (MTA) With Dycal
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|ClinicalTrials.gov Identifier: NCT01224925|
Recruitment Status : Completed
First Posted : October 20, 2010
Last Update Posted : December 11, 2015
|Condition or disease||Intervention/treatment||Phase|
|Carious Exposure Human Permanent First and Second Molars Mature Teeth Proximal Caries Healthy Pulp Reversible Pulpitis||Procedure: direct pulp capping over carious exposure Procedure: Direct pulp capping||Not Applicable|
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 are lacking.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Randomized Controlled Trial of Pulp Capping Over Carious Exposures Comparing MTA With Dycal|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Active Comparator: Dycal - calcium hydroxide material
Pulp capping with Dycal
Procedure: direct pulp capping over carious exposure
Dycal: covered with Fuji IX
Other Name: Dycal DENTSPLY DeTrey
Active Comparator: WMTA - White Mineral Trioxide Aggregate
Pulp capping with Mineral Trioxide Aggregate
Procedure: Direct pulp capping
WMTA capping over exposed pulp, wet pellet, FujiIX
Other Name: WMTA - White Mineral Trioxide Aggregate
- A non-symptomatic tooth that is responding to sensitivity testing and does not have any periapical changes [ Time Frame: 36 month ]Clinical examination including pulp testing, and radiological examination
- The pain history of the tooth at baseline and postoperatively during the first week. [ Time Frame: one week ]Pain existing immediately postoperatively, during the first week, and at the one-week appointment is recorded.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01224925
|Sandessjoen Dental Clinic|
|Sandnessjoen, Norway, 8800|
|Tromso University Dental Clinic|
|Tromso, Norway, 9037|
|Principal Investigator:||Rita Kundzina, DDS, PhD||University of Tromso,Faculty of Health Sciences, Institute of Clinical Dentistry|