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Hemostatic Efficacy of AriClot Powder (absorbable modified starch) in Postoperative Bleeding Reduction after Impacted Lower Third Molar surgery: A Randomized Clinical Trial

 View older revisions Content changed at 2024-08-15, 1403/05/25

Protocol summary

Study aim
To evaluate the efficacy of AriClot hemostatic powder in reducing postoperative bleeding after impacted lower third molar extraction compared to patients treated with gauze compress
Design
This is a single-blinded, parallel, phase 3 RCT with 60 patients. participants will be block-randomized in 1:1 ratio to intervention (Ariclot powder) or control group (gauze compress).
Settings and conduct
at Imam Reza clinic in Shiraz, after tooth removal, patients in the intervention group will receive application of Ariclot powder directly into the site. a similar amount of powder (1 gram) will be used. Gauze and pressure will be applied after using the powder. patients in the control group will receive only a gauze compress. Bleeding time, Hemostasis status after 5, 10, 30, and 60 seconds, Bleeding amount before reaching homeostasis, Surgeon assessment of powder hemostatic ability during surgery, and the existence of delayed bleeding 1 day and 1 week after surgery will be assessed. Sterile drapes will cover patients' faces during the procedure to blind them from seeing the application. also, statistical analysis will be conducted in two groups without drug specifications.
Participants/Inclusion and exclusion criteria
patients aged 18-35 with an impacted mandibular third molar who do not have underlying renal, hepatic, periodontal, or coagulation disorders.
Intervention groups
Intervention group: patients with an impacted mandibular third molar for whom the powder will be used to control bleeding according to the instructions after the surgery. Control group: Similar patients but without the use of powder for bleeding. that gauze and pressure will be applied to control bleeding.
Main outcome variables
Bleeding control time; Bleeding amount; Surgeon satisfaction, delayed bleeding

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231004059609N1
Registration date: 2024-01-24, 1402/11/04
Registration timing: registered_while_recruiting

Last update: 2024-08-15, 1403/05/25
Update count: 1
Registration date
2024-01-24, 1402/11/04
Registrant information
Name
mohsen mardani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3626 3193
Email address
mardanimo@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-21, 1402/11/01
Expected recruitment end date
2024-02-10, 1402/11/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Hemostatic Efficacy of AriClot Powder (absorbable modified starch) in Postoperative Bleeding Reduction after Impacted Lower Third Molar surgery: A Randomized Clinical Trial
Public title
Hemostatic Efficacy of AriClot Powder in Postoperative Bleeding Reduction after Impacted Lower Third Molar surgery
Purpose
Prevention
Inclusion/Exclusion criteria
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
Age
From 18 years old to 35 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 60
More than 1 sample in each individual
Number of samples in each individual: 2
each participant may provide 2 impacted mandibular third molars which fit the inclusion criteria for the research.
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomly assigned to receive either AriClot powder (experimental group) or gauze compress (control group) in a 1:1 allocation ratio using block randomization. The randomization sequence is generated by a statistician not involved in the trial using an online tool to create a blocked randomization list (Sealed Envelope). the specifications used to create this table are: Block sizes: 4, 6,8, Actual list length: 60, Treatment group: Group A, Group B. A list of 60 random A or B is produced Which corresponds to group assignment, with A indicating allocation to the AriClot group and B indicating allocation to the control group. As each participant enrolls in the study, the research coordinator will assign them to the treatment specified by the next sequential number on the randomized list. Group allocation will be documented for each participant but concealed from study investigators and patients until after tooth extraction procedures are completed.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, single blinding of patients will be used to reduce potential bias. Patients will have their faces covered during the procedure, so they are unaware of which intervention, AriClot powder or gauze compress, they receive. However, due to the obvious physical differences between the powder and gauze, complete blinding of the operating surgeon is not feasible. Since the surgeon must directly apply the allocated treatment and assess the outcomes, they will be able to recognize whether a participant receives powder or gauze. Furthermore, the statistician analyzing the data will also remain blinded to group allocation to prevent bias during data analysis.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
5th Floor, Shiraz University Central Building, Jomhuri Eslami Blvd
City
Shiraz
Province
Fars
Postal code
84471-71946
Approval date
2023-12-20, 1402/09/29
Ethics committee reference number
IR.SUMS.DENTAL.REC.1402.081

Health conditions studied

1

Description of health condition studied
Haemorrhage after Impacted Lower Third Molar Extraction
ICD-10 code
T81.0
ICD-10 code description
Haemorrhage and haematoma complicating a procedure, not elsewhere classified

Primary outcomes

1

Description
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.

2

Description
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 outcomes

1

Description
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.

2

Description
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

Intervention groups

1

Description
Intervention group: patients will undergo impacted lower third molar extraction. after tooth removal, patients in the intervention group will receive application of Ariclot powder directly into the site. a similar amount of powder (1 gram) will be used. Gauze and pressure will be applied after using the powder. Ariclot powder is modified and sterile polysaccharide powder, produced by Knowledge-based Healda Company and is biocompatible and biodegradable.
Category
Treatment - Drugs

2

Description
Control group: patients will undergo impacted lower third molar extraction. after tooth removal, without the use of powder, that gauze and pressure will be applied to control bleeding.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza clinic
Full name of responsible person
Mohsen Mardani
Street address
Namazi square
City
Shiraz
Province
Fars
Postal code
7134814734
Phone
+98 917 119 2690
Email
mardanimo@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hashem Hashempur
Street address
Shiraz university of medical science central building , Zand Street
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
hashempurm@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Pegah Farrahi
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
6th Alley , Farhangshahr St.
City
Shiraz
Province
Fars
Postal code
7187965653
Phone
+98 71 3631 0895
Fax
Email
Pegah.farrahi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohsen Mardani
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Maxillofacial surgery
Street address
Qasrodasht st
City
Shiraz
Province
Fars
Postal code
14111-71546
Phone
+98 71 3626 3193
Fax
Email
mardanimo@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Pegah Farrahi
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Alley 6, Farhangshahr St.
City
Shiraz
Province
Fars
Postal code
7187965653
Phone
+98 71 3631 0895
Fax
Email
Pegah.farrahi@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available

Trial results

Please tick if results have been published
Yes
Summary result posting date
2024-08-15, 1403/05/25
Table of baseline comparison
Characteristic AriClot Group (n=30) Control Group (n=30) Total (N=60) P value
Age (years) 25.7 ± 3.5 25.5 ± 3.3 25.6 ± 3.4 P = 0.85
Gender Male 15 (50.0%) 14 (47%) 29 (48%) P = 0.8
Female 15 (50.0%) 16 (53%) 31 (52%) P = 0.8

Participant flow diagram
  • 60 patients invloved 
    • Control group (30)
      • Male: 14
      • Female 16
    • AriClot group (30)
      • Male: 15
      • female: 15

 

 

 

  • inclusion criteria : at least one mesioangular fully impacted mandibular third molar necessitating surgical extraction. •Exclusion criteria included bleeding disorders, anticoagulant medication use, severe periodontal disease, need for more than two carpules of 2% lidocaine (1: 100,000 epinephrine) for anesthesia, history of allergic reactions to sugar compounds, and medical conditions such as renal, hepatic, or diabetic disorders.

 

Table of variable outcomes' results

The use of AriClot powder resulted in a significantly lower mean bleeding amount (in grams) compared to the control group (0.28 ± 0.08 g vs. 0.37 ± 0.07 g, p<0.001). the statistical analysis revealed no significant difference in the overall hemostasis time between the two groups (p=0.07). However, there was a trend toward faster hemostasis achievement in the Ariclot group compared to the control group. Bleeding control was analyzed at specific time points of 5, 10, 30, and 60 seconds post-extraction. Within 5 seconds, 16.7% of the AriClot group achieved hemostasis, while no cases in the control group did (p=0.02). By 10 seconds post-extraction, 43.3% of the AriClot group had achieved bleeding cessation, compared to just 26.7% in the gauze group (p=0.13). By 30 seconds, 83% of AriClot patients demonstrated complete hemostasis, which was more than the 73% rate seen in the control group (p=0.26). At 60 seconds, all AriClot patients had successful bleeding control, while 6.7% of cases in the control group had not yet achieved hemostasis

 

During the first day post-operatively, a significantly higher proportion of participants in the control group experienced delayed bleeding compared to the Ariclot group (31.0% vs. 7.1%, p=0.022). during the first week, only two participants (both from the control group) reported persistent oozing or bleeding, with no significant group difference (p=0.157).

The surgeon's assessment of hemostatic ability showed a significant association with the treatment group (p<0.001). In the study group, the majority (53.3%) were rated as "good" hemostatic ability (rating =3), and 33.3% as "excellent” (rating=4). In Group B, the majority (53.3%) were rated as "fair” (rating=2), with no cases rated as "excellent".

Table of adverse events

There was no report of side effect as local irritation,  Erythema , Delay woud healing of increased rate of infection in both Control or AriClot Group 

First publication date
empty
Abstract of published paper
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.
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