Blood Mercury Levels Following Retrograde Amalgam Surgeries

This study has been completed.
Sponsor:
Collaborator:
School of Dentistry, Isfahan University of Medical Sciences
Information provided by (Responsible Party):
Masoud Saatchi, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01428609
First received: September 2, 2011
Last updated: March 21, 2012
Last verified: March 2012
  Purpose

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 Intervention Phase
Blood Mercury Concentration
Procedure: Amalgam
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official Title: Blood Mercury Levels Following Retrograde Amalgam Surgeries

Resource links provided by NLM:


Further study details as provided by Isfahan University of Medical Sciences:

Primary Outcome Measures:
  • Blood mercury concentration [ Time Frame: within the 7 days after surgery ] [ Designated as safety issue: Yes ]

Enrollment: 14
Study Start Date: September 2009
Study Completion Date: December 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
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)
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
School of Dentistry, 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:
No publications provided

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
Study First Received: September 2, 2011
Last Updated: March 21, 2012
Health Authority: Iran: Ministry of Health

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

ClinicalTrials.gov processed this record on October 20, 2014