Tooth Extraction
Conditions
Brief 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.
Interventions
DEVICEAxiostat
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.
DEVICECotton Gauze
Size: 1 x 1 cm
Sponsors
Axio Biosolutions Pvt. Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* Patients undergoing a single tooth or multiple extractions in same quadrant; and those with an allergy to seafood.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to achieve haemostasis | 1 Day | Time to achieve hemostasis by observing the time at which blood oozing through or from periphery of the dressing stops. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain & Healing Scale | Upto 1 Day | Patients comfort level as assessed by verbal inquiry after completion of procedure. |
Outcome results
None listed