NCT01224925

RCT of Pulp Capping Over Carious Exposure in Adults

Randomized Controlled Trial of Pulp Capping Over Carious Exposures Comparing MTA With Dycal

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: University of Tromso · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This multicentre study was a randomized, controlled, parallel, patient-blinded, two-arm superiority trial with a 1:1 allocation ratio that followed the CONSORT guidelines.The 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 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.

Conditions

• Carious Exposure
• Human Permanent First and Second Molars
• Mature Teeth
• Proximal Caries
• Healthy Pulp
• Reversible Pulpitis

Interventions

Type	Name	Description
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
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.

Timeline

• Start date: 2010-10-18
• Primary completion: 2015-12-10
• Completion: 2015-12-10
• First posted: 2010-10-20
• Last updated: 2019-03-18
• Results posted: 2019-03-18

Locations

4 sites across 2 countries: Lithuania, Norway