Comparison of The Success Rates of Four Different Pulpotomy Techniques

April 28, 2017 updated by: Yeliz Guven, Istanbul University
This randomized clinical trial was conducted to examine and compare the effectiveness of pulpotomy in primary molars treated with calcium silicate based materials including Biodentine and two different mineral trioxide aggregate (MTA) products (white ProRoot® MTA and MTA Plus®). Ferric sulfate pulpotomy was selected to represent the control group. 116 primary molars in 29 children were treated by pulpotomy and followed for a period of 24 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 3

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

5 years to 7 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients were eligible if they were 5 to 7 years old, healthy and cooperative, and had at least four carious primary molars, each of which was in a different quadrant and required a pulpotomy. The criteria for the selection of the teeth to be included in the study were presence of deep caries, presence of at least two-thirds of the root length radiographically and being restorable.

Exclusion Criteria:

  • The exclusion criteria were the presence of 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) space, furcal or periapical radiolucency and teeth requiring more than 5 minutes to achieve hemostasis during clinical procedure. Teeth without permanent successor were not also included in the study.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Biodentine
Biodentine pulpotomy agent
Drug: Biodentine
Other Names:
  • 77509635
Experimental: ProRoot MTA
ProRoot MTA pulpotomy agent
Drug: ProRoot (Aggregate)
Other Names:
  • 75896452
Experimental: MTA Plus
MTA Plus pulpotomy agent
Drug: MTA Plus
Other Names:
  • 85303191
Active Comparator: Ferric Sulfate 20% Dental Gel
Ferric Sulfate %20 Dental Gel pulpotomy agent
Drug: Ferric Sulfate 20 % Dental Gel
Other Names:
  • Viscostat

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total success rate
Time Frame: 6 months after pulpotomy treatment
Number of molars with both clinically and radiographically successful
6 months after pulpotomy treatment
Total success rate
Time Frame: 12 months after pulpotomy treatment
Number of molars with both clinically and radiographically successful
12 months after pulpotomy treatment
Total success rate
Time Frame: 24 months after pulpotomy treatment
Number of molars with both clinically and radiographically successful
24 months after pulpotomy treatment

Collaborators and Investigators

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

Sponsor

Istanbul University

Investigators

  • Principal Investigator: Yeliz Guven, Dr., 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)

March 15, 2013

Primary Completion (Actual)

January 15, 2014

Study Completion (Actual)

February 15, 2016

Study Registration Dates

First Submitted

April 26, 2017

First Submitted That Met QC Criteria

April 28, 2017

First Posted (Actual)

May 1, 2017

Study Record Updates

Last Update Posted (Actual)

May 1, 2017

Last Update Submitted That Met QC Criteria

April 28, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2012/1728-1288

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

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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