Comparison of MedCem MTA and Formocresol Used in Pulpotom... | NCT01962077

Studies
Comparison of MedCem MTA and Formocresol Used in Pulpotomies in Primary Teeth.

NCT01962077

Sponsor

Hadassah Medical Organization

Status

Completed

Last Update Posted

Jul 6, 2021Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Pulpotomies Primary Teeth
Effectiveness of MedCem MTA® in Pulpotomies Primary Teeth

Interventions

MedCem MTA pulpotomies in primary teeth.

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2013

Primary Completion Date

Jun 2021Actual

Completion Date

Jun 2021Actual

First Submitted Date

Sep 25, 2013

First Submission Date that Met QC Criteria

Oct 10, 2013

First Posted Date

Oct 14, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 1, 2021

Last Update Posted Date

Jul 6, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

assess the effect of MedCem MTA as a pulp medicament following pulpotomy in human primary molars with carious pulp exposure in comparison to Formocresol.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MedCem MTA pulpotomies	Experimental		Procedure: MedCem MTA pulpotomies in primary teeth.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MedCem MTA pulpotomies in primary teeth.	Procedure		MedCem MTA pulpotomies

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Success of MedCem MTA pulpotomy in primary molar	No pain, no swelling or sinus tract, no internal root resorption progressing into the bone, no furcation and/or periapical bond destruction.	Up to 36 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy children
with Asymptomatic primary molars with a deep carious lesion;
Exposure of a vital pulp by caries;
No clinical or radiographic evidence of pulp degeneration, such as excessive bleeding from the root canal, internal root resorption, inter-radicular and/or periapical bone destruction,swelling, or sinus tract;
Ability to perform a leakage free restoration of the teeth using stainless steel crown, or amalgam/resin based restoration.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

10 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah Medical Organization		Jerusalem		91120	Israel