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

Phase 3

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

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

Primary Outcome Measures

Name	Time	Method
Bleeding amount before reaching homeostasis. Timepoint: when no further bleeding is observed. Method of measurement: it will be Measured using pre-weighed sterile surgical gauzes placed directly on the site. gauzes will be weighed before and after use to determine grams of blood absorbed.;Bleeding time. Timepoint: when no further bleeding is observed. Method of measurement: it will be measured using a stopwatch from the time the tooth is removed and powder/gauze and pressure are applied until the bleeding stops completely.

Secondary Outcome Measures

Name	Time	Method
Surgeon satisfaction with the hemostatic ability of the powder. Timepoint: when no further bleeding is observed. Method of measurement: This will be evaluated using a predefined scoring system based on surgeon satisfaction with the hemostatic ability of the powder. The scoring system consists of 4 scores ranging from 1 to 4. A score of 1 indicates poor bleeding control, a score of 2 indicates fair bleeding control, a score of 3 indicates good bleeding control and a score of 4 indicates excellent control of bleeding.;Delayed bleeding. Timepoint: 1 day and 1 week after surgery. Method of measurement: Patients will be followed up 1day and 1 week after surgery and will be asked about existence of delayed bleeding.