Blood Mercury ConcentrationPhase 4NCT01428609
Blood Mercury Levels Following Retrograde Amalgam Surgeries
A Phase 4 study testing Amalgam in people with Blood Mercury Concentration, run by Masoud Saatchi at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Mercury Concentration
- What is being tested?
- Amalgam
- Type of treatment
- Surgery or procedure
- How many people
- 14 participants
- Where
- 1 siteIran
- Study dates
- Sep 2009to Dec 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- older than 18 years
- without physician-diagnosed psychological, behavioral, neurological, immunosuppressive, or renal disorders
- having a tooth that required apical surgery
Who cannot join
- using tobacco and alcohol one week before surgery and during the study
- dealing with mercury in their job like dentists, stonemason, mine workers
Trial locations and contacts
1 site in 1 country.
Iran1 site
School of Dentistry, Isfahan University of Medical Sciences
Isfahan, Isfahan, 8174673461
About this study
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.
Read the 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
- Conditions
- Blood Mercury Concentration
- Being tested
- Amalgam
- Keywords
- Amalgam, Mercury, Endodontics, Apicoectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmalgamProcedure or surgery
Also called cold-vapor atomic absorption spectrometry(Shimadzu, AA-10)
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood mercury concentration
Measured: within the 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2011 (estimated)
- Study startSep 2009
- Primary completionDec 2009
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Mercury ConcentrationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masoud Saatchi
- Sponsor type
- University, hospital or other
- Collaborators
- Isfahan University of Medical Sciences
- Responsible party
- Sponsor-investigator, Masoud Saatchi, Isfahan University of Medical Sciences
- Investigators
- Masoud Saatchi, DDS, MS, Study chair, Department of Endodontics and Torabinejad Dental Research Center, School of Dentistry, Isfahan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01428609
- Sponsor's protocol ID
- MUI79275
- Status last verified
- Mar 2012
- First submitted
- 2 Sep 2011
- Last updated
- 22 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Mercury Levels Following Retrograde Amalgam Surgeries
- ClinicalTrials.gov ID
- NCT01428609
- Acronym / sponsor ID
- MUI79275
- Conditions
- Blood Mercury Concentration
- Keywords
- Amalgam, Mercury, Endodontics, Apicoectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Masoud SaatchiUniversity, hospital or other
- Collaborators
- Isfahan University of Medical Sciences
- Study start
- Sep 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 5 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- older than 18 years
- without physician-diagnosed psychological, behavioral, neurological, immunosuppressive, or renal disorders
- having a tooth that required apical surgery
Key exclusion criteria (2 listed)
- using tobacco and alcohol one week before surgery and during the study
- dealing with mercury in their job like dentists, stonemason, mine workers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmalgamAlso: cold-vapor atomic absorption spectrometry(Shimadzu, AA-10)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. | Procedure or surgery | – |
Primary outcome
Blood mercury concentration
Time frame: within the 7 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2012.
- Web Site of Isfahan University of Medical SciencesLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Masoud Saatchi, DDS, MS study chair
Department of Endodontics and Torabinejad Dental Research Center, School of Dentistry, Isfahan University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amalgam in people with Blood Mercury Concentration, run by Masoud Saatchi at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood mercury concentration (time frame: within the 7 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2012.