RCT of Pulp Capping Over Carious Exposure in Adults

December 7, 2018 updated by: Rita Kundzina, University of Tromso

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Lithuania
      • Klaipeda, Lithuania, 91210
        • Avimeda Dental Clinic
  • Norway
      • Alta, Norway, 9510
        • Alta Dental Clinic
      • Sandnessjoen, Norway, 8800
        • Sandessjoen Dental Clinic
      • Tromso, Norway, 9037
        • Tromso University Dental Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Age 18-55 years
  • 1st and 2nd permanent molars
  • Proximal caries to inner 1/3 of dentin (bite-wing)
  • Apex closed, no periapical changes (apical radiograph)
  • No periodontal pockets deeper than 4mm
  • Medical history non-contributory (incl.pregnancy)
  • No medication (no antibiotics during last month)
  • No signs or symptoms more severe than reversible pulpitis
  • Positive response to electrical pulp test(EPT) or cold test
  • Written consent Inclusion requires compliance with all the criteria listed

Exclusion criteria:

  • During the treatment there will be no pulpal exposure
  • The bleeding of the exposed pulp cannot be controled in 10 minutes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • (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 Names:
  • WMTA - White Mineral Trioxide Aggregate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
44 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Tromso

Collaborators

Norwegian Public dental health service

Investigators

  • Principal Investigator: Rita Kundzina, DDS, PhD, University of Tromso,Faculty of Health Sciences, Institute of Clinical Dentistry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 18, 2010

Primary Completion (Actual)

December 10, 2015

Study Completion (Actual)

December 10, 2015

Study Registration Dates

First Submitted

October 18, 2010

First Submitted That Met QC Criteria

October 19, 2010

First Posted (Estimate)

October 20, 2010

Study Record Updates

Last Update Posted (Actual)

March 18, 2019

Last Update Submitted That Met QC Criteria

December 7, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UiT-IKO-MTA-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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