Hemostatic Efficacy of AriClot Powder in Postoperative Bleeding Reduction after Impacted Lower Third Molar surgery

Phase 3

Completed

• Conditions: Haemorrhage after Impacted Lower Third Molar Extraction.; Haemorrhage and haematoma complicating a procedure, not elsewhere classified; T81.0

• Registration Number: IRCT20231004059609N1
• Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary

background: Achieving effective hemostasis is crucial during the surgical removal of impacted third molars to minimize postoperative bleeding complications. This study evaluated the hemostatic efficacy of AriClot Powder, an absorbable modified starch-based agent, in reducing bleeding following impacted lower third molar extractions. Materials and Methods: This prospective, randomized, single-blinded controlled trial included 60 participants undergoing surgical removal of impacted mandibular third molars at a single institution. Participants were randomly allocated in a 1:1 ratio to receive either AriClot Powder topically applied to the extraction socket (n=30) or conventional pressure applied with gauze as per standard practice (control, n=30). The primary outcomes were bleeding amount before hemostasis, hemostasis time, surgeon's assessment of hemostatic ability, and incidence of delayed bleeding 24 hours and 1 week post-surgery. Results: The AriClot Powder group demonstrated significantly lower bleeding amount compared to the control group (0.28±0.08g vs. 0.37±0.07g, p<0.001). While the overall hemostasis time was not statistically different between groups, a higher proportion of AriClot Powder cases achieved hemostasis within specific time points. Surgeon ratings favored AriClot Powder for hemostatic ability. The incidence of delayed bleeding at 24 hours post-op was significantly lower in the AriClot Powder group (7.1% vs. 31.0%, p=0.022). Conclusion: In this randomized controlled trial, AriClot Powder demonstrated superior hemostatic efficacy compared to conventional gauze compression, minimizing intraoperative bleeding and reducing the risk of delayed postoperative bleeding after impacted third molar surgery. These findings highlight the potential of AriClot Powder as a promising solution for improving hemostasis and enhancing patient outcomes in oral and maxillofacial surgical procedures.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2024-08-26

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

patients aged 18-35 having at least one fully mesioangular impacted mandibular third molar requiring surgical extraction

Exclusion Criteria

bleeding disorders
use of anticoagulant medication
severe periodontal disease
history of allergic reactions to starch
medical conditions such as renal, hepatic, or diabetic disorders
a requirement of over 2 carpules of 2% lidocaine for anesthesia

Study & Design

• Study Type: interventional
• Study Design: Not specified