Pulpotomy With Various MTA Materials and Ferric Sulphate

March 4, 2019 updated by: SULTAN KELES, Aydin Adnan Menderes University

Clinical and Radiographic Comparison of RetroMTA, OrthoMTA And Ferric Sulfate for Pulpotomy in Primary Molars

The aim of this study was to determine clinical and radiographic efficacy of the newly developed OrthoMTA and RetroMTA , compared frequently used ferric sulfate for pulpotomy in primary second molars.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A total of 96 second primary second molars from 32 children ,who met inclusion criteria and were 5-9 years old were selected for the study. Teeth were randomly divided into three groups according to the planned treatment: O-MTA (n=32 teeth), R-MTA (n=32 teeth) and FS (n=32 teeth). Clinical and radiographical follow-up examinations were conducted at 3, 6 and 9 months postoperatively. The data were evaluated with Chi-square test, Cochran Q test, Post-Huc Dunn test and Kaplan-Meier analysis.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

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
      • Aydin, Turkey, 09100
        • Sultan Keles

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

3 years to 7 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients have at least three deep carious primary second molars
  • Teeth with no spontaneous pain
  • Patient who are willing to participate
  • Cooperative children

Exclusion Criteria:

  • Patients who are not willing to participate
  • History of systemic disease
  • Pathological mobility
  • Presence of internal or external root resorption
  • Presence of apical radiolucency

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Ferric sulphate
Group FS. Teeth in this goup will pulpotomized with ferris-sulphate.
Procedure: Ferric sulphate
Teeth were pulpotomized with ferric sulphate in this group.
Experimental: Orto-mta
Group O-MTA.Teeth in this goup will pulpotomized with Ortho-mta.
Procedure: Ortho-MTA
Teeth were pulpotomized with Ortho-MTA in this group.
Experimental: Retro-mta
Group R-MTA. Teeth in this goup will pulpotomized with Retro-mta.
Procedure: Retro-MTA
Teeth were pulpotomized with Retro-MTA in this group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical success rate
Time Frame: Change of clinical success from Baseline at 18 months
Clinical success
Change of clinical success from Baseline at 18 months

Collaborators and Investigators

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

Sponsor

Aydin Adnan Menderes University

Investigators

  • Principal Investigator: sultan keles, Dr., Pediatric dentistry

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 (Actual)

June 2, 2017

Primary Completion (Actual)

June 30, 2018

Study Completion (Actual)

December 30, 2018

Study Registration Dates

First Submitted

October 22, 2018

First Submitted That Met QC Criteria

October 23, 2018

First Posted (Actual)

October 24, 2018

Study Record Updates

Last Update Posted (Actual)

March 5, 2019

Last Update Submitted That Met QC Criteria

March 4, 2019

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-047

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

We will share the results.

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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