Blood Mercury Levels Following Retrograde Amalgam Surgeries

March 21, 2012 updated by: Masoud Saatchi
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.

Study Overview

Status

Completed

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Isfahan, Iran, Islamic Republic of, 8174673461
        • School of Dentistry, Isfahan University of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Triple

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

September 2, 2011

First Submitted That Met QC Criteria

September 2, 2011

First Posted (Estimate)

September 5, 2011

Study Record Updates

Last Update Posted (Estimate)

March 22, 2012

Last Update Submitted That Met QC Criteria

March 21, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • MUI79275

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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