Comparison of Biodentine and MTA Pulpotomies in the Primary Molar Teeth 3 Year Follow up

January 3, 2018 updated by: Mine Koruyucu, Istanbul University
The aim of this study is to compare two pulpotomy medicaments in primary molars clinically.A total of 200 primary molars with deep caries were treated with two different pulpotomy medicaments (Mineral Trioxide Aggregate and BiodentineTM) in this study. The inclusion criteria for tooth selection were no clinical and radiographic evidence of pulp pathology. During 36 months of follow-up at 3-month intervals, clinical and radiographic success and failures were recorded.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Early Phase 1

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

  • Turkey
      • Istanbul, Turkey, 34093
        • Istanbul University

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

7 years to 15 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • no clinical and radiographic evidence of pulp pathology,
  • no clinical and radiographic symptoms,
  • no history of spontaneous pain and tenderness,
  • no percussion, swelling or sinus tracts and pathologic mobility.

Exclusion Criteria:

  • any clinical or radiographic evidence of pulp degeneration (spontaneous or nocturnal tooth pain, tenderness to percussion, pathological mobility, internal or external root resorption, swelling or fistula, widened periodontal ligament (PDL)
  • furcal or periapical radiolucency teeth requiring more than 5 minutes to achieve hemostasis during clinical procedure.
  • without permanent successor

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 Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Biodentine
Dental materials
Drug: Biodentine
Biodentine pulpotomy agent
Other Names:
  • 77509635
Drug: ProRoot (Aggregate)
ProRoot MTA pulpotomy agent
Other Names:
  • 75896452
Experimental: ProRoot MTA
Dental Materials
Drug: Biodentine
Biodentine pulpotomy agent
Other Names:
  • 77509635
Drug: ProRoot (Aggregate)
ProRoot MTA pulpotomy agent
Other Names:
  • 75896452

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total success rate
Time Frame: 12 months after pulpotomy treatment
12 months after pulpotomy treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Total success rate
Time Frame: 24 months after pulpotomy treatment
24 months after pulpotomy treatment

Other Outcome Measures

Outcome Measure
Time Frame
Total success rate
Time Frame: 36 months after pulpotomy treatment
36 months after pulpotomy treatment

Collaborators and Investigators

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

Sponsor

Istanbul University

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 (Actual)

May 1, 2013

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 30, 2016

Study Registration Dates

First Submitted

December 26, 2017

First Submitted That Met QC Criteria

January 3, 2018

First Posted (Actual)

January 10, 2018

Study Record Updates

Last Update Posted (Actual)

January 10, 2018

Last Update Submitted That Met QC Criteria

January 3, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-24692

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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