NCT02286648

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2014

Completed
7 months until next milestone

First Posted

Study publicly available on registry

November 10, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Last Updated

November 10, 2014

Status Verified

November 1, 2014

Enrollment Period

1.4 years

First QC Date

April 25, 2014

Last Update Submit

November 7, 2014

Conditions

PulpitisDental Pulp DiseaseTooth Diseases

Keywords

clinical signschildpulpotomy

Outcome Measures

Primary Outcomes (1)

  • 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

    up to 12 months

Secondary Outcomes (1)

  • successful outcome of treatment as indicated by radiographic signs defined with observation and check list

    up to 12 months

Study Arms (2)

Mineral Trioxide Aggregate

EXPERIMENTAL

pulpotomy with MTA

Drug: Mineral Trioxide Aggregate

Formocresol

ACTIVE COMPARATOR

pulpotomy with FC

Drug: Formocresol

Interventions

FormocresolDRUG

pulpotomy with formocresol

Formocresol
Mineral Trioxide AggregateDRUG

pulpotomy with MTA

Mineral Trioxide Aggregate

Eligibility Criteria

Age4 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • healthy people(without any systemic disease)
  • teeth :
  • no clinical or radiographic evidence of pulp degeneration
  • the possibility of proper restoration of the teeth

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mashhad University of Medical Siences

Mashhad, Khorasan Razavi, 9185769516, Iran

RECRUITING

Mashhad University of Medical Siences

Mashhad, Khorasan Razavi, 9185769516, Iran

RECRUITING

MeSH Terms

Conditions

PulpitisDental Pulp DiseasesTooth DiseasesSigns and Symptoms

Interventions

formocresolmineral trioxide aggregate

Condition Hierarchy (Ancestors)

Stomatognathic DiseasesPathological Conditions, Signs and Symptoms

Central Study Contacts

Hossein Nematollahi, associate prof.

CONTACT

+989151141688nematollahih@mums.ac.ir

Homa Noorollahian, Associate prof.

CONTACT

+989155577184noorollahianh@mums.ac.ir

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

April 25, 2014

First Posted

November 10, 2014

Study Start

February 1, 2014

Primary Completion

July 1, 2015

Last Updated

November 10, 2014

Record last verified: 2014-11

Locations

IR(2)