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RCT of Pulp Capping Over Carious Exposure in Adults

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ClinicalTrials.gov Identifier: NCT01224925
Recruitment Status : Completed
First Posted : October 20, 2010
Results First Posted : March 18, 2019
Last Update Posted : March 18, 2019
Sponsor:
Collaborator:
Norwegian Public dental health service
Information provided by (Responsible Party):
Rita Kundzina, 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.

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 with Dycal 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 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multicenter study a randomized, controlled, parallel, patient-blinded, two-arm superiority trial with a 1:1 allocation ratio
Masking: Single (Participant)
Masking Description: Patient -blinded
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Pulp Capping Over Carious Exposures Comparing MTA With Dycal
Actual Study Start Date : October 18, 2010
Actual Primary Completion Date : December 10, 2015
Actual Study Completion Date : December 10, 2015

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 Name: (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 Name: WMTA - White Mineral Trioxide Aggregate




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): NCT01224925


Locations
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Lithuania
Avimeda Dental Clinic
Klaipeda, Lithuania, 91210
Norway
Alta Dental Clinic
Alta, Norway, 9510
Sandessjoen Dental Clinic
Sandnessjoen, Norway, 8800
Tromso University Dental Clinic
Tromso, Norway, 9037
Sponsors and Collaborators
University of Tromso
Norwegian Public dental health service
Investigators
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Principal Investigator: Rita Kundzina, DDS, PhD University of Tromso,Faculty of Health Sciences, Institute of Clinical Dentistry
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
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 ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rita Kundzina, DDS,PhD (Associate professor (endodontics), University of Tromso
ClinicalTrials.gov Identifier: NCT01224925    
Other Study ID Numbers: UiT-IKO-MTA-001
First Posted: October 20, 2010    Key Record Dates
Results First Posted: March 18, 2019
Last Update Posted: March 18, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Rita Kundzina, University of Tromso:
carious exposure
pulp capping
MTA
Dycal
Additional relevant MeSH terms:
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Pulpitis
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases