RCT of Pulp Capping Over Carious Exposure in Adults

Not Applicable

Completed

• Conditions: Human Permanent First and Second Molars; Proximal Caries; Healthy Pulp; Reversible Pulpitis; Carious Exposure; Mature Teeth
• Interventions: Procedure: Direct pulp capping with Dycal; Procedure: Direct pulp capping

• Registration Number: NCT01224925
• Lead Sponsor: University of Tromso

Brief 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.

Study Timeline

• Study Start: 2010-10-18
• Study First Submitted: 2010-10-18
• Study First Submitted QC: 2010-10-19
• Study First Posted: 2010-10-20
• Primary Completion: 2015-12-10
• Study Completion: 2015-12-10
• Results First Submitted: 2017-01-24
• Status Verified: 2018-12
• Results First Submitted QC: 2018-12-07
• Last Update Submitted: 2018-12-07
• Results First Posted: 2019-03-18
• Last Update Posted: 2019-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Capping over carious exposure with Dycal	Direct pulp capping with Dycal	Total caries removal. In case of pulp exposure Direct Pulp capping with (Dycal®, Dentsply DeTrey GmbH, Konstanz, Germany)
Capping over carious exposure with WMTA	Direct pulp capping	Total caries removal. In case of pulp exposure Direct Pulp capping with Mineral Trioxide Aggregate White ProRoot® (WMTA) (DENTSPLY, Tulsa Dental, Tulsa, OK, USA)

Primary Outcome Measures

Name	Time	Method
Survival of Capped Pulps	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.

Secondary Outcome Measures

Name	Time	Method
Postoperative Pain 1 Week After Treatment.	one week	Pain existing immediately postoperatively, during the first week, and at the one-week appointment is recorded.

Trial Locations

Locations (4)

Sandessjoen Dental Clinic; 🇳🇴 Sandnessjoen, Norway

Avimeda Dental Clinic; 🇱🇹 Klaipeda, Lithuania

Alta Dental Clinic; 🇳🇴 Alta, Norway

Tromso University Dental Clinic; 🇳🇴 Tromso, Norway