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MEDCEM PC and MTA in Pulpotomies of Primary Molars

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: NCT02291120
Recruitment Status : Unknown
Verified November 2014 by Cristina Cuadros, Universitat Internacional de Catalunya.
Recruitment status was:  Recruiting
First Posted : November 14, 2014
Last Update Posted : November 14, 2014
Information provided by (Responsible Party):
Cristina Cuadros, Universitat Internacional de Catalunya

Brief Summary:
The objective of the study is to evaluate and compare, clinically and radiographically,the effects of MEDCEM PC and MTA when used as pulp dressings following pulpotomy in human primary molars.

Condition or disease Intervention/treatment Phase
Evaluate the Effects of MEDCEM PC and MTA in Pulpotomies of Primary Molars. Procedure: Pulpotomy Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : March 2014
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : December 2016

Arm Intervention/treatment
Active Comparator: MTA
ProRoot® MTA is a root canal repair material that is a unique improvement over other materials used for root canal repair. Made up of fine hydrophilic particles that set in the presence of water, ProRoot® MTA seals off all pathways between the root canal system and surrounding tissues, significantly reducing bacterial migration. Its excellent compatibility with the dentinal wall allows for a predictable clinical healing response.
Procedure: Pulpotomy
Experimental: MedCem Portland Cement (PC)
MedCem PC is an excellent capping material for cariology on permanent teeth (direct and indirect capping) and in milk tooth endodontics (milk tooth amputation). Is characterized by excellent colour stability and neutrality and does not contain any additional ingredients
Procedure: Pulpotomy

Primary Outcome Measures :
  1. Clinical success [ Time Frame: 24 months ]
    No pain, no swelling, no fistula or sinus tract, no pathologic mobility

  2. Radiographic success [ Time Frame: 24 months ]
    No internal root resorption progressing into the bone, no external root resorption, no furcation and/or periapical bone destruction

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • healthy children
  • molars showing: symptomless exposure of vital pulp by caries no clinical or radiographic evidence of pulp degeneration (excessive bleeding from the root canal, internal root resorption, inter-radicular and/or furcal bone destruction) the possibility of proper restoration of the teeth no physiological resorption of more than one-third of the root

Exclusion Criteria:

  • presence of systemic pathology
  • history of allergic reaction to latex, local anaesthetics or to the constituents of the test pulp dressing agents

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): NCT02291120

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Universitat Internacional de Catalunya Recruiting
Sant Cugat del Valles, Barcelona, Spain, 08195
Contact: Cristina Cuadros Fernandez, DDS, MsC    0034 93 5045000   
Sponsors and Collaborators
Universitat Internacional de Catalunya
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Responsible Party: Cristina Cuadros, Master's Program Director in Pediatric Dentistry, Universitat Internacional de Catalunya Identifier: NCT02291120    
Other Study ID Numbers: UIC-ODP-4
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: November 14, 2014
Last Verified: November 2014