RCT of Pulp Capping Over Carious Exposure in Adults
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|ClinicalTrials.gov Identifier: NCT01224925|
Recruitment Status : Completed
First Posted : October 20, 2010
Results First Posted : March 18, 2019
Last Update Posted : March 18, 2019
|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 with Dycal 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 on adult teeth are lacking.At 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Multicenter study a randomized, controlled, parallel, patient-blinded, two-arm superiority trial with a 1:1 allocation ratio|
|Masking Description:||Patient -blinded|
|Official Title:||Randomized Controlled Trial of Pulp Capping Over Carious Exposures Comparing MTA With Dycal|
|Actual Study Start Date :||October 18, 2010|
|Actual Primary Completion Date :||December 10, 2015|
|Actual Study Completion Date :||December 10, 2015|
Active Comparator: Capping over carious exposure with Dycal
Total caries removal. In case of pulp exposure Direct Pulp capping with (Dycal®, Dentsply DeTrey GmbH, Konstanz, Germany)
Procedure: Direct pulp capping with Dycal
Capping over carious exposure with Dycal. Dycal: covered with Fuji IX. After one week, part of the temporary filling was left under the permanent filling
Other Name: (Dycal®, Dentsply DeTrey GmbH, Konstanz, Germany
Experimental: Capping over carious exposure with WMTA
Total caries removal. In case of pulp exposure Direct Pulp capping with Mineral Trioxide Aggregate White ProRoot® (WMTA) (DENTSPLY, Tulsa Dental, Tulsa, OK, USA)
Procedure: Direct pulp capping
WMTA capping over exposed pulp, wet pellet, Fuji IX. After one week, the entire temporary filling was removed,the cavity was permanently restored with a composite resin material used at the study clinic.
Other Name: WMTA - White Mineral Trioxide Aggregate
- Survival of Capped Pulps [ Time Frame: 44 month ]Survival was defined as a non-symptomatic tooth that responded to sensibility testing and did not exhibit any periapical changes. Follow-up included pulpal testing and periapical radiograph at 6, 12, 24, and 36 months was planned . Patients who come with delay for last checkup where included in the study.
- Postoperative Pain 1 Week After Treatment. [ 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
|Avimeda Dental Clinic|
|Klaipeda, Lithuania, 91210|
|Alta Dental Clinic|
|Alta, Norway, 9510|
|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|