Tooth ExtractionNCT03108365
Evaluating the Effectiveness of Axiostat Hemostatic Dressing Material Versus Conventional Method of Hemostasis and Healing of Extraction Wounds in Patients on Oral Anti-Platelet Drugs - A Comparative Study
A study testing Axiostat and Cotton Gauze in people with Tooth Extraction, run by Axio Biosolutions Pvt. Ltd..
Trial summary
The rationale of this study was to evaluate the efficacy of Axiostat hemostatic dental dressing in achieving hemostasis post-extraction and determining its effect on pain and healing of the extraction wound, compared to control, i.e. conventional method of extraction in patients on oral anti-platelet therapy. Read more about this study
- Who is it for?
- Ages 35 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Extraction
- What is being tested?
- Axiostat and Cotton Gauze
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 19 Dec 2014to 24 Mar 2016
- 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 35 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing multiple tooth extractions aged b/w 35- 70 years and with INR values ≤ 3.5 (1-3.5)
- If present, sugar level should be under control
Who cannot join
- Patients undergoing a single tooth or multiple extractions in same quadrant; and those with an allergy to seafood.
About this study
The rationale of this study was to evaluate the efficacy of Axiostat hemostatic dental dressing in achieving hemostasis post-extraction and determining its effect on pain and healing of the extraction wound, compared to control, i.e. conventional method of extraction in patients on oral anti-platelet therapy.
- Conditions
- Tooth Extraction
- Being tested
- Axiostat, Cotton Gauze
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AxiostatDevice
Also called Chitosan haemostatic dressing
Axiostat® is a sterile, non-absorbable haemostatic dressing intended to control profuse bleeding within minutes of application by providing an active mechanical barrier to the wound site.
Axiostat® stops moderate to severe bleeding due to cuts, abrasions, lacerations, venous/arterial punctures and more. Mechanism of action is such that Axiostat® is an extremely positive dressing that becomes very sticky in the presence of negatively charged blood and thus seals the wound area.
Cotton GauzeDevice
Size: 1 x 1 cm
| Study group | Role | What they receive |
|---|---|---|
| Axiostat | Experimental | Size: 1 x 1 cm
Chitosan based haemostatic dressing Receives: Device: Axiostat |
| Cotton Gauze | Active comparator | Size: 1 x 1 cm Receives: Device: Cotton Gauze |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to achieve haemostasis
Time to achieve hemostasis by observing the time at which blood oozing through or from periphery of the dressing stops.
Measured: 1 Day
Secondary outcomes (1)
Pain & Healing Scale
Patients comfort level as assessed by verbal inquiry after completion of procedure.
Measured: Upto 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start19 Dec 2014
- Primary completion24 Mar 2016
- Study completion24 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth ExtractionStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Axio Biosolutions Pvt. Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Tejraj Kale, Principal investigator, KLE Dental College, Belgaun
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03108365
- Sponsor's protocol ID
- ABPL/004
- Status last verified
- Apr 2017
- First submitted
- 30 Mar 2017
- Last updated
- 5 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of Axiostat Hemostatic Dressing Material Versus Conventional Method of Hemostasis and Healing of Extraction Wounds in Patients on Oral Anti-Platelet Drugs - A Comparative Study
- ClinicalTrials.gov ID
- NCT03108365
- Acronym / sponsor ID
- ABPL/004
- Conditions
- Tooth Extraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Axio Biosolutions Pvt. Ltd.University, hospital or other
- Study start
- 19 Dec 2014 (actual)
- Primary completion
- 24 Mar 2016 (actual)
- Study completion
- 24 Mar 2016 (actual)
- First posted
- 11 Apr 2017 (actual)
- 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 rationale of this study was to evaluate the efficacy of Axiostat hemostatic dental dressing in achieving hemostasis post-extraction and determining its effect on pain and healing of the extraction wound, compared to control, i.e. conventional method of extraction in patients on oral anti-platelet therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Axiostat | Experimental | Device: AxiostatSize: 1 x 1 cm Chitosan based haemostatic dressing |
| Cotton Gauze | Active comparator | Device: Cotton GauzeSize: 1 x 1 cm |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing multiple tooth extractions aged b/w 35- 70 years and with INR values ≤ 3.5 (1-3.5)
- If present, sugar level should be under control
Key exclusion criteria (1 listed)
- Patients undergoing a single tooth or multiple extractions in same quadrant; and those with an allergy to seafood.
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 |
|---|---|---|
| AxiostatAlso: Chitosan haemostatic dressingAxiostat® is a sterile, non-absorbable haemostatic dressing intended to control profuse bleeding within minutes of application by providing an active mechanical barrier to the wound site. Axiostat® stops moderate to severe bleeding due to cuts, abrasions, lacerations, venous/arterial punctures and more. Mechanism of action is such that Axiostat® is an extremely positive dressing that becomes very sticky in the presence of negatively charged blood and thus seals the wound area. | Device | Axiostat |
| Cotton GauzeSize: 1 x 1 cm | Device | Cotton Gauze |
Primary outcome
Time to achieve haemostasis
Time frame: 1 Day
Time to achieve hemostasis by observing the time at which blood oozing through or from periphery of the dressing stops.
1 secondary outcome
Pain & Healing Scale
Time frame: Upto 1 Day
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 5 Jul 2019.
- Publication in Journal of Contemporary Dental MedicineLink provided by the sponsor.
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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.
Dr. Tejraj Kale principal investigator
KLE Dental College, Belgaun
Questions about this trial
What is this clinical trial studying?
A study testing Axiostat and Cotton Gauze in people with Tooth Extraction, run by Axio Biosolutions Pvt. Ltd..
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 2 inclusion and 1 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 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Time to achieve haemostasis (time frame: 1 Day). 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 5 Jul 2019.