Blood Mercury Levels Following Retrograde Amalgam Surgeries | NCT01428609

Studies
Blood Mercury Levels Following Retrograde Amalgam Surgeries

NCT01428609

Sponsor

Masoud Saatchi

Status

Completed

Last Update Posted

Mar 22, 2012Estimated

Enrollment

14Actual

Phase

Phase 4

Conditions

Blood Mercury Concentration

Interventions

Amalgam

Countries

Iran

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 2012

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

Sep 2009

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2010Actual

First Submitted Date

Sep 2, 2011

First Submission Date that Met QC Criteria

Sep 2, 2011

First Posted Date

Sep 5, 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 21, 2012

Last Update Posted Date

Mar 22, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Masoud Saatchi, Associate Professor of Endodontics, Isfahan University of Medical SciencesSponsor-Investigator

Lead Sponsor

Masoud SaatchiOTHER

Collaborators

Name	Class
Isfahan University of Medical Sciences	OTHER

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 determine the blood's mercury level of patients who had amalgam root end filling surgeries. It is to be examined if the mercury concentration in blood is elevated by using amalgam retroseal.

Detailed Description

A total of 14 patients who needs surgical root canal therapy (SRCT) participated in this clinical study.
The Isfahan University Human Subjects Review Committee approved the protocol of the study.
All patients filled in the consent form.
Apicoectomy with retrograde amalgam filling performed for all participant.
Blood samples were collected in three period of time immediately before and immediately after each surgery and also one week later.
Each time 10 ml blood was drawn from each patient.
Analysis of total mercury in blood samples was performed using cold-vapor atomic absorption spectrometry

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Amalgam	Procedure	In all surgical intervention a zinc free amalgam (Tytin. Kerr Sybron Crop., Romulus, MI) was used in the root end prepared spaces as root end filling material. Blood samples were collected in three period of time immediately before and immediately after each surgery and also one week later.		cold-vapor atomic absorption spectrometry(Shimadzu, AA-10)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood mercury concentration		within the 7 days after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

older than 18 years
without physician-diagnosed psychological, behavioral, neurological, immunosuppressive, or renal disorders
having a tooth that required apical surgery

Exclusion Criteria:

using tobacco and alcohol one week before surgery and during the study
dealing with mercury in their job like dentists, stonemason, mine workers

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Masoud Saatchi, DDS, MS	Department of Endodontics and Torabinejad Dental Research Center, School of Dentistry, Isfahan University of Medical Sciences	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
School of Dentistry, Isfahan University of Medical Sciences		Isfahan	Isfahan	8174673461	Iran

Label	URL
Web Site of Isfahan University of Medical Sciences	View source

Intervention Browse Module

MeSH Terms

ID	Term
D003723	Dental Amalgam

Ancestor Terms

ID	Term
D003722	Dental Alloys
D003764	Dental Materials
D001697	Biomedical and Dental Materials
D008420	Manufactured Materials

Browse Leaves

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Browse Branches

Not provided