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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01224925
Recruitment Status : Completed
First Posted : October 20, 2010
Last Update Posted : December 11, 2015
Public Dental Service Competence Centre of Northern Norway
Norwegian Public dental health service
Information provided by (Responsible Party):
University of Tromso

Brief Summary:
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 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 over carious exposure Procedure: Direct pulp capping Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Pulp Capping Over Carious Exposures Comparing MTA With Dycal
Study Start Date : October 2010
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. A non-symptomatic tooth that is responding to sensitivity testing and does not have any periapical changes [ Time Frame: 36 month ]
    Clinical examination including pulp testing, and radiological examination

Secondary Outcome Measures :
  1. The pain history of the tooth at baseline and postoperatively during the first week. [ Time Frame: one week ]
    Pain existing immediately postoperatively, during the first week, and at the one-week appointment is recorded.

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01224925

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

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
Eriksen HM, Bergdahl M, Byrkjeflot L-I, Crossner C-G, Tillberg A Evaluation of a dental outreach teaching program. Eur J Dent Educ 2010;(in press)

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Tromso Identifier: NCT01224925     History of Changes
Other Study ID Numbers: UiT-IKO-MTA-001
First Posted: October 20, 2010    Key Record Dates
Last Update Posted: December 11, 2015
Last Verified: December 2015

Keywords provided by University of Tromso:
carious exposure
pulp capping

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