NCT01428609

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 5, 2011

Completed
Last Updated

March 22, 2012

Status Verified

March 1, 2012

Enrollment Period

3 months

First QC Date

September 2, 2011

Last Update Submit

March 21, 2012

Conditions

Blood Mercury Concentration

Keywords

AmalgamMercuryEndodonticsApicoectomy

Outcome Measures

Primary Outcomes (1)

  • Blood mercury concentration

    within the 7 days after surgery

Interventions

AmalgamPROCEDURE

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.

Also known as: cold-vapor atomic absorption spectrometry(Shimadzu, AA-10)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Dentistry, Isfahan University of Medical Sciences

Isfahan, Isfahan, 8174673461, Iran

Location

Related Links

MeSH Terms

Interventions

Dental Amalgam

Intervention Hierarchy (Ancestors)

Dental AlloysDental MaterialsBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Masoud Saatchi, DDS, MS

    Department of Endodontics and Torabinejad Dental Research Center, School of Dentistry, Isfahan University of Medical Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor of Endodontics

Study Record Dates

First Submitted

September 2, 2011

First Posted

September 5, 2011

Study Start

September 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2010

Last Updated

March 22, 2012

Record last verified: 2012-03

Locations

IR(1)