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

Axio Biosolutions

Status: Completed

Conditions: Tooth Extraction

Treatments: Device: Axiostat; Device: Cotton Gauze

Study type: Interventional

Funder types: Other

Identifiers

NCT03108365

ABPL/004

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 35 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Axiostat

Experimental group

Description:

Size: 1 x 1 cm Chitosan based haemostatic dressing

Treatment:

Device: Axiostat

Cotton Gauze

Active Comparator group

Description:

Size: 1 x 1 cm

Treatment:

Device: Cotton Gauze