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Blood Mercury Levels Following Retrograde Amalgam Surgeries

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ClinicalTrials.gov Identifier: NCT01428609
Recruitment Status : Completed
First Posted : September 5, 2011
Last Update Posted : March 22, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Blood Mercury Concentration Procedure: Amalgam Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Official Title: Blood Mercury Levels Following Retrograde Amalgam Surgeries
Study Start Date : September 2009
Primary Completion Date : December 2009
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mercury
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Procedure: Amalgam
    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.
    Other Name: cold-vapor atomic absorption spectrometry(Shimadzu, AA-10)

Outcome Measures

Primary Outcome Measures :
  1. Blood mercury concentration [ Time Frame: within the 7 days after surgery ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01428609


Locations
Iran, Islamic Republic of
School of Dentistry, Isfahan University of Medical Sciences
Isfahan, Iran, Islamic Republic of, 8174673461
Sponsors and Collaborators
Masoud Saatchi
Isfahan University of Medical Sciences
Investigators
Study Chair: Masoud Saatchi, DDS, MS Department of Endodontics and Torabinejad Dental Research Center, School of Dentistry, Isfahan University of Medical Sciences
More Information

Additional Information:
Responsible Party: Masoud Saatchi, Associate Professor of Endodontics, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01428609     History of Changes
Other Study ID Numbers: MUI79275
First Posted: September 5, 2011    Key Record Dates
Last Update Posted: March 22, 2012
Last Verified: March 2012

Keywords provided by Masoud Saatchi, Isfahan University of Medical Sciences:
Amalgam
Mercury
Endodontics
Apicoectomy