RCT of Pulp Capping Over Carious Exposures Comparing Mineral Trioxide Aggregate (MTA) With Dycal

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Public Dental Service Competence Centre of Northern Norway
Norwegian Public dental health service
Information provided by (Responsible Party):
University of Tromso
ClinicalTrials.gov Identifier:
NCT01224925
First received: October 18, 2010
Last updated: June 28, 2013
Last verified: June 2013
  Purpose

The purpose of this study is 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.


Condition Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Pulp Capping Over Carious Exposures Comparing MTA With Dycal

Resource links provided by NLM:


Further study details as provided by University of Tromso:

Primary Outcome Measures:
  • A non-symptomatic tooth that is responding to sensitivity testing and does not have any periapical changes [ Time Frame: 36 month ] [ Designated as safety issue: No ]
    Clinical examination including pulp testing, and radiological examination


Secondary Outcome Measures:
  • The pain history of the tooth at baseline and postoperatively during the first week. [ Time Frame: one week ] [ Designated as safety issue: No ]
    Pain existing immediately postoperatively, during the first week, and at the one-week appointment is recorded.


Estimated Enrollment: 160
Study Start Date: October 2010
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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 are lacking.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01224925

Locations
Norway
Sandessjoen Dental Clinic
Sandnessjoen, Norway, 8800
Tromso University Dental Clinic
Tromso, Norway, 9037
Sponsors and Collaborators
University of Tromso
Public Dental Service Competence Centre of Northern Norway
Norwegian Public dental health service
Investigators
Principal Investigator: Rita Kundzina, DDS, PhD University of Tromso,Faculty of Health Sciences, Institute of Clinical Dentistry
  More Information

Publications:
Zander HA. Reaction of the pulp to calcium hydroxide. J Dent Res 1939;18:373-9
Hørsted-Bindslev P, Bergenholtz G. Vital pulp therapies. In: Bergenholtz G,Hørsted-Bindslev P, Reit C. Textbook of endodontology. Blackwell Munksgaard,Oxford;2003:66-91

Responsible Party: University of Tromso
ClinicalTrials.gov Identifier: NCT01224925     History of Changes
Other Study ID Numbers: UiT-IKO-MTA-001
Study First Received: October 18, 2010
Last Updated: June 28, 2013
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by University of Tromso:
carious exposure
pulp capping
MTA
Dycal

Additional relevant MeSH terms:
Pulpitis
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on August 28, 2014