Clinical Trials Logo
  1. Home
  2. Tooth Extraction
  3. NCT03108365
  4. Details
NCT03108365 Clinical Trial

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

Tooth Extraction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03108365
Other study ID # ABPL/004
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 19, 2014
Est. completion date March 24, 2016

Study information
Verified date April 2017
Source Axio Biosolutions Pvt. Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date March 24, 2016
Est. primary completion date March 24, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 35 Years to 70 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Axiostat
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 Gauze
Size: 1 x 1 cm

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Axio Biosolutions Pvt. Ltd.

Outcome
Type Measure Description Time frame Safety issue
Primary Time to achieve haemostasis Time to achieve hemostasis by observing the time at which blood oozing through or from periphery of the dressing stops. 1 Day
Secondary Pain & Healing Scale Patients comfort level as assessed by verbal inquiry after completion of procedure. Upto 1 Day
See also
  Status Clinical Trial Phase
Completed NCT04166890 - Comparison of the Efficacy and Safety of Two Homologous Active Principles for Local Dental Anesthesia Phase 4
Active, not recruiting NCT02952209 - The Effect of Alveolar Ridge Preservation After Tooth Extraction in the Posterior Maxilla N/A
Completed NCT02155764 - Ridge Preservation With New Class of Osteoplastic Materials Phase 2
Completed NCT01588444 - Ridge Preservation After Tooth Extraction Using Cortical Versus Cancellous Freeze Dried Bone Allograft N/A
Completed NCT00387140 - A Study to Evaluate the Safety and Efficacy of an Investigational Drug in the Treatment of Postoperative Dental Pain (MK-2295-005) Phase 2
Recruiting NCT06245161 - Efficacy of Computer Controlled Intraosseous Anesthesia in Pediatric Dental Patients N/A
Recruiting NCT05615272 - Treatment of Alveolar Osteitis: Traditional or Regenerative? N/A
Completed NCT05101954 - Platelet Rich Fibrin and Concentrated Growth Factors on Osseointegration of Immediate Implants N/A
Completed NCT03985033 - The Clinical and Biological Effects of Leucocyte and Platelet-rich Fibrin (L-PRF) on Post-extraction Sockets Healing N/A
Completed NCT04082598 - Antibiotic Therapy in Erupted Tooth Extractions Phase 4
Completed NCT01924390 - Histological Comparison of Ridge Preservation Using Mineralized FDBA Alone Versus a Combined Mineralized-Demineralized Freeze Dried Bone Allograft N/A
Completed NCT04930497 - Vestibular Socket Therapy With and Without Bone Grafting N/A
Completed NCT03191448 - Ridge Preservation Using FDBA and a Collagen Wound Dressing in Molar Sites N/A
Completed NCT03211312 - Prediction Model of Cardiac Risk for Dental Extraction in Elderly Patients With Cardiovascular Diseases
Withdrawn NCT06038695 - Immediate Implant Placement Using Volume-Stable Collagen Matrix Combined With rhPDGF-BB N/A
Completed NCT05845437 - On Adequacy of Referrals to Oral and Maxillofacial Surgery
Recruiting NCT05220462 - Remimazolam vs Midazolam Cognitive and Motor Recovery After Intravenous Conscious Sedation for Dental Extractions. Phase 3
Active, not recruiting NCT03943680 - Plasma Rich in Growth Factors in Post-extraction Sockets N/A
Recruiting NCT05106855 - Comparative Study of Immediate Single Unit Implants in Early Loading Protocols, With or Without Photobiomodulation. N/A
Completed NCT03487718 - A 14 Weeks Longitudinal Study to Investigate the Effect of Leukocyte- Platelet Rich Fibrin Plug on the Quality of the Newly Formed Bone in Ridge Preservation Procedure Following a Tooth Extraction. It is a Clinical, Radiographic and Histomorphometric Study. N/A

External Links