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Success Rate Evaluation of Miniature Pulpotomy With MTA in Primary Molars

Primary Purpose

Pulpitis, Dental Pulp Disease, Tooth Diseases

Status
Unknown status
Phase
Phase 4
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Formocresol
Mineral Trioxide Aggregate
Sponsored by
Mashhad University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulpitis focused on measuring clinical signs, child, pulpotomy

Eligibility Criteria

4 Years - 7 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • healthy people(without any systemic disease)

  • teeth :

    • no clinical or radiographic evidence of pulp degeneration
    • the possibility of proper restoration of the teeth

Exclusion Criteria:

  • teeth :

    • excessive bleeding from the exposure site
    • internal root resorption
    • interradicular and/or periapical bone destruction
    • swelling or sinus tract

Sites / Locations

  • Mashhad University of Medical SiencesRecruiting
  • Mashhad University of Medical SiencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mineral Trioxide Aggregate

Formocresol

Arm Description

pulpotomy with MTA

pulpotomy with FC

Outcomes

Primary Outcome Measures

successful outcome of treatment as indicated by clinical signs defined with observation and check list
success or failure of treatment defined with observation and check list

Secondary Outcome Measures

successful outcome of treatment as indicated by radiographic signs defined with observation and check list
success or failure of treatment defined with observation and check list

Full Information

First Posted
April 25, 2014
Last Updated
November 7, 2014
Sponsor
Mashhad University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02286648
Brief Title
Success Rate Evaluation of Miniature Pulpotomy With MTA in Primary Molars
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mashhad University of Medical Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the clinical and radiographic success rate of Miniature pulpotomy with Mineral Trioxide Aggregate (MTA) in primary molars.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulpitis, Dental Pulp Disease, Tooth Diseases
Keywords
clinical signs, child, pulpotomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mineral Trioxide Aggregate
Arm Type
Experimental
Arm Description
pulpotomy with MTA
Arm Title
Formocresol
Arm Type
Active Comparator
Arm Description
pulpotomy with FC
Intervention Type
Drug
Intervention Name(s)
Formocresol
Intervention Description
pulpotomy with formocresol
Intervention Type
Drug
Intervention Name(s)
Mineral Trioxide Aggregate
Intervention Description
pulpotomy with MTA
Primary Outcome Measure Information:
Title
successful outcome of treatment as indicated by clinical signs defined with observation and check list
Description
success or failure of treatment defined with observation and check list
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
successful outcome of treatment as indicated by radiographic signs defined with observation and check list
Description
success or failure of treatment defined with observation and check list
Time Frame
up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: healthy people(without any systemic disease) teeth : no clinical or radiographic evidence of pulp degeneration the possibility of proper restoration of the teeth Exclusion Criteria: teeth : excessive bleeding from the exposure site internal root resorption interradicular and/or periapical bone destruction swelling or sinus tract
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hossein Nematollahi, associate prof.
Phone
+989151141688
Email
nematollahih@mums.ac.ir
First Name & Middle Initial & Last Name or Official Title & Degree
Homa Noorollahian, Associate prof.
Phone
+989155577184
Email
noorollahianh@mums.ac.ir
Facility Information:
Facility Name
Mashhad University of Medical Siences
City
Mashhad
State/Province
Khorasan Razavi
ZIP/Postal Code
9185769516
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hossein Nematollahi, associate of professor
First Name & Middle Initial & Last Name & Degree
Homa Noorollahian, associate of professor
First Name & Middle Initial & Last Name & Degree
Hossein Nematollahi, associate of professor
Facility Name
Mashhad University of Medical Siences
City
Mashhad
State/Province
Khorasan Razavi
ZIP/Postal Code
9185769516
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hossein Nematollahi, associate of professor
First Name & Middle Initial & Last Name & Degree
Homa Noorollahian, associate of professor

12. IPD Sharing Statement

Learn more about this trial

Success Rate Evaluation of Miniature Pulpotomy With MTA in Primary Molars

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