Tooth ExtractionsNCT00707564
Study of Hemostatic Efficacy of the HemCon Dental Dressing in a Population Treated With Anticoagulant Medications
A study testing HemCon Dental Dressing and Gauze with pressure in people with Tooth Extractions, run by HemCon Medical Technologies, Inc at 2 sites in United States.
Trial summary
The purpose of this study is to determine if the HemCon Dental Dressing is effective in stopping bleeding during dental surgeries in patients taking anticoagulant medications. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Tooth Extractions
- What is being tested?
- HemCon Dental Dressing and Gauze with pressure
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2008to Jan 2009
- Phase
- Interventional
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who are currently taking oral anticoagulant medications and eligible for surgery following standards of care
- Patients requiring a minimum of 2 tooth extraction procedures.
- Index pairing must reflect anatomically similar extraction locations
- 14 years of age or older
- Available for a minimum of one post operative evaluation approximately 7 days post surgery
- Extraction sites do not require primary closure or suturing
- Willingness and ability to provide informed consent/ assent
Who cannot join
- Scheduled to undergo a procedure other than tooth extractions
- In the Investigators opinion, dental surgery may pose a serious risk of uncontrollable bleeding due to anticoagulant use
- Scheduled to undergo 2 extractions, anatomically dissimilar
- Extraction procedures are expected to require primary closure or suture
- Unwilling or unable to provide informed consent/ assent
- Patients undergoing bisphosphonate therapy
- Patients not under current treatment with an oral anticoagulant medication
- Patients who have discontinued the use of anticoagulant medications for a minimum of 3 days prior to the planned surgical visit
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rodney Nichols, DMD
Milwaukie, Oregon, 97222
Jay P. Malmquist, DMD
Portland, Oregon, 97221
About this study
Official title: A Randomized, Self-Controlled Clinical Study of Hemostatic Efficacy of the HemCon Dental Dressing in a Population Treated With Anticoagulant Medications
The purpose of this study is to determine if the HemCon Dental Dressing is effective in stopping bleeding during dental surgeries in patients taking anticoagulant medications.
Read the detailed description
As the HemCon® Dental Dressing has been FDA cleared for use as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief, the proposed study will further investigate the safety and efficacy of hemostasis of the dressing for use in dental surgical procedures that do not require primary closure (suturing) such as tooth extractions. This protocol will specifically research the safety and efficacy of hemostasis within a population of subjects taking anticoagulant medications.
- Conditions
- Tooth Extractions
- Being tested
- HemCon Dental Dressing, Gauze with pressure
- Keywords
- hemostasis, tooth extractions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemCon Dental DressingDevice
Also called HemCon Dental Dressing.
The HemCon Dental Dressing is an oral wound dressing made of chitosan
Gauze with pressureDevice
Also called Generic brand gauze with pressure.
Gauze with pressure
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | HemCon Dental Dressing Receives: Device: HemCon Dental Dressing |
| 2 | Active comparator | Gauze with pressure Receives: Device: Gauze with pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to hemostasis
Measured: minutes after application
Secondary outcomes (1)
Incidence of post surgical sequela
Measured: 1 week post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionJan 2009
- Study completionJan 2009
Why it stopped: unable to enroll patient population
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth ExtractionsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- HemCon Medical Technologies, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jay Malmquist, DMD, Principal investigator, Jay P. Malmquist, DMD, PC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00707564
- Sponsor's protocol ID
- 2007-I-D-2
- Status last verified
- Sep 2012
- First submitted
- 27 Jun 2008
- Last updated
- 24 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Self-Controlled Clinical Study of Hemostatic Efficacy of the HemCon Dental Dressing in a Population Treated With Anticoagulant Medications
- ClinicalTrials.gov ID
- NCT00707564
- Acronym / sponsor ID
- 2007-I-D-2
- Conditions
- Tooth Extractions
- Keywords
- hemostasis, tooth extractions
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: unable to enroll patient population
- Enrolment
- 0 participants (actual)
- Lead sponsor
- HemCon Medical Technologies, IncIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 1 Jul 2008 (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 purpose of this study is to determine if the HemCon Dental Dressing is effective in stopping bleeding during dental surgeries in patients taking anticoagulant medications.
Detailed description
As the HemCon® Dental Dressing has been FDA cleared for use as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief, the proposed study will further investigate the safety and efficacy of hemostasis of the dressing for use in dental surgical procedures that do not require primary closure (suturing) such as tooth extractions. This protocol will specifically research the safety and efficacy of hemostasis within a population of subjects taking anticoagulant medications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: HemCon Dental DressingHemCon Dental Dressing |
| 2 | Active comparator | Device: Gauze with pressureGauze with pressure |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Patients who are currently taking oral anticoagulant medications and eligible for surgery following standards of care
- Patients requiring a minimum of 2 tooth extraction procedures.
- Index pairing must reflect anatomically similar extraction locations
- 14 years of age or older
- Available for a minimum of one post operative evaluation approximately 7 days post surgery
Key exclusion criteria (8 listed)
- Scheduled to undergo a procedure other than tooth extractions
- In the Investigators opinion, dental surgery may pose a serious risk of uncontrollable bleeding due to anticoagulant use
- Scheduled to undergo 2 extractions, anatomically dissimilar
- Extraction procedures are expected to require primary closure or suture
- Unwilling or unable to provide informed consent/ assent
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 |
|---|---|---|
| HemCon Dental DressingAlso: HemCon Dental Dressing.The HemCon Dental Dressing is an oral wound dressing made of chitosan | Device | 1 |
| Gauze with pressureAlso: Generic brand gauze with pressure.Gauze with pressure | Device | 2 |
Primary outcome
Time to hemostasis
Time frame: minutes after application
1 secondary outcome
Incidence of post surgical sequela
Time frame: 1 week post surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2012.
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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.
Jay Malmquist, DMD principal investigator
Jay P. Malmquist, DMD, PC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HemCon Dental Dressing and Gauze with pressure in people with Tooth Extractions, run by HemCon Medical Technologies, Inc at 2 sites in United States.
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 7 inclusion and 8 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: withdrawn, as of the sponsor's last update on 24 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Time to hemostasis (time frame: minutes after application). 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 24 Sep 2012.