MTA and Biodentine in Pulpotomized Primary Molars

November 11, 2014 updated by: Cristina Cuadros

Clinical and Radiographic Outcomes of MTA and Biodentine in Pulpotomized Primary Molars. A Randomized Clinical Trial

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

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

  • Spain
    • Barcelona
      • Sant Cugat del Vallès, Barcelona, Spain, 08195
        • Universitat Internacional de Catalunya

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

4 years to 9 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • molars showing:

    1. symptomless exposure of vital pulp by caries
    2. no clinical or radiographic evidence of pulp degeneration (excessive bleeding from the root canal, internal root resorption, inter-radicular and/or furcal bone destruction)
    3. the possibility of proper restoration of the teeth
    4. no physiological resorption of more than one-third of the root

Exclusion Criteria:

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

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pulp dressing agent
Other: Pulpotomy
Comparison of two different pulp dressing agents
Other Names:
  • Biodentine
Active Comparator: Pulp dressing
MTA
Other: Pulpotomy
Comparison of two different pulp dressing agents
Other Names:
  • Biodentine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of molars with clinical success
Time Frame: 12 months
12 months
Number of molars with radiographic success
Time Frame: 6 and 12 months
6 and 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of molars with no evidence of radicular radiolucency
Time Frame: 6 and 12 months
6 and 12 months
Number of molars with no evidence of internal resorption
Time Frame: 6 and 12 months
6 and 12 months
Number of molars with no evidence of external resorption
Time Frame: 6 and 12 months
6 and 12 months
Number of molars with no evidence of furcation radiolucency
Time Frame: 6 and 12 months
6 and 12 months
Number of molars with no symptoms of pain
Time Frame: 6 and 12 months
6 and 12 months
Number of molars without swelling
Time Frame: 6 and 12 months
6 and 12 months
Number of molars without fistulation
Time Frame: 6 and 12 months
6 and 12 months
Number of molars without pathological mobility.
Time Frame: 6 and 12 months
6 and 12 months

Collaborators and Investigators

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

Sponsor

Cristina Cuadros

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

March 1, 2012

Primary Completion (Actual)

February 1, 2014

Study Completion (Anticipated)

November 1, 2014

Study Registration Dates

First Submitted

April 30, 2012

First Submitted That Met QC Criteria

May 1, 2012

First Posted (Estimate)

May 3, 2012

Study Record Updates

Last Update Posted (Estimate)

November 13, 2014

Last Update Submitted That Met QC Criteria

November 11, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • UIC-ODP-1

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.

Clinical Trials on Primary Molar Pulpotomy

Clinical Trials on Pulpotomy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jamaica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe