Acidity Level of Blood From Primary Molar's Pulp While Un... | NCT01486537

Studies
Acidity Level of Blood From Primary Molar's Pulp While Undergoing Pulpotomy or Pulpectomy Procedure

NCT01486537

Sponsor

Hadassah Medical Organization

Status

Completed

Last Update Posted

Mar 16, 2022Actual

Enrollment

87Actual

Phase

Not provided

Conditions

Healthy

Interventions

Not provided

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

Mar 2022

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

Dec 2011

Primary Completion Date

Nov 2020Actual

Completion Date

Nov 2020Actual

First Submitted Date

Dec 3, 2011

First Submission Date that Met QC Criteria

Dec 5, 2011

First Posted Date

Dec 6, 2011Estimated

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

Mar 14, 2022

Last Update Posted Date

Mar 16, 2022Actual

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

The aim of this study is to evaluate the level of acidity of blood samples that are been taken from pulp chambers of primary molars undergoing pulpotomy or pulpectomy procedures. Our hypothesis is that samples from teeth undergoing pulpectomy would be acidic while samples from teeth undergoing pulpotomy would bo neutral.

Detailed Description

The samples will be collected by 1 m"l syringe that is pre-washed with Heparin.than the samples will be analyzed in an Astrop machine of neonates.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

87Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

no systemic disease
teeth that are undergoing pulpotomy or pulpectomy

Exclusion Criteria:

systemic disease
pulp necrosis
permanent teeth

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

13 Years

Standard Ages

Child

Study Population

healthy children undergoing dental treatment by residents in Hadassah hospital Jerusalem.

Ages between 3-13 years old.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Moti Moskovitz, Dr.	Hadassah Medical Organization	Principal Investigator

Locations

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