Investigating the hemostatic effect of a surgical hemostat sponge containing aloevera nanoparticles after extraction of the mandible first and second molars
Investigating the level of blood retention in a surgical hemostat sponge containing aloe vera nanoparticles after extraction of the first and second molars of the mandible
Design
The clinical trial will have a control group, with parallel groups, double-blind, randomized, on 30 patients, simple randomization and one-to-one.
Settings and conduct
In each patient, after tooth extraction, a commercial gel stamp will be randomly placed in the dental cavity for dressing, then a commercial gel stamp will be placed in the dental cavity in the other tooth cavity. The amount of bleeding will be measured in the first 1 hour after tooth extraction and at 4 and 24 hours after tooth extraction.
Participants/Inclusion and exclusion criteria
30 patients with the age range of 20 to 45 years who need simultaneous extraction of two mandibular first or second molar teeth.
Intervention groups
Test group: One of the two first or second mandibular of patients in which the production geltamp (a sponge made of gelatin without any drug) will be placed. How to use; In each patient, after extracting the tooth, a production geltamp will be placed in the extracted tooth cavity. Duration of use: It will remain in the place for at least 4 days and after that, it can be discarded or left in the place until complete absorption (10 days).
Control group: One of the two first or second mandibular of patients in which the commercial geltamp (a sponge made of gelatin without any drug) will be placed. How to use; In each patient, after extracting the tooth, a commercial geltamp will be placed in the extracted tooth cavity. Duration of use: It will remain in the place for at least 4 days and after that, it can be discarded or left in the place until complete absorption (10 days).
Main outcome variables
Blood clotting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200919048756N8
Registration date:2024-05-16, 1403/02/27
Registration timing:prospective
Last update:2024-05-16, 1403/02/27
Update count:0
Registration date
2024-05-16, 1403/02/27
Registrant information
Name
Solmaz Maleki Dizaj
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 3161
Email address
maleki.s.89@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-30, 1403/03/10
Expected recruitment end date
2024-09-21, 1403/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the hemostatic effect of a surgical hemostat sponge containing aloevera nanoparticles after extraction of the mandible first and second molars
Public title
Investigating the hemostatic effect of a surgical hemostat sponge
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Need for extraction of two mandibular first molars
Age between 20-45 years
No corticosteroids and antibiotics using in the last month
No coagulation disorders
No acute or uncontrolled infection at the dental surgery site
No malignancy at the dental surgery site
No site exposure Radiation surgery
No contraceptives using at last month
No smoking
No hypertension, diabetes, thyroid disorders and blood diseases
Exclusion criteria:
People taking anticoagulants
Not signing the consent form
Having a systemic disease
Patients whose teeth do not come out normally and need surgery and sectioning
Age
From 20 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
2
In each patient after tooth extraction, a produced geltamp will be placed in the extracted tooth cavity (test group). In the other tooth, a
Randomization (investigator's opinion)
Randomized
Randomization description
Commercial geltamp and the produced geltamp are both packaged and sterilized. One geltamp will be labeled as group a and the other geltamp will be labeled as group b. The dental surgeon, who is blind to geltamp type, is required to use one type a and one type b in each patient. The randomization method will be simple and will be alternate. In this way, if in the first patient the geltamp type a will be placed on the right jaw, in the second patient the geltamp type a will be placed on the left, and so on until the end. And of course on the other side the geltamp b will be placed, which will also be alternate.
Blinding (investigator's opinion)
Double blinded
Blinding description
Commercial geltamp and the produced geltamp are both packaged and sterilized. One geltamp will be labeled as group a and the other geltamp will be labeled as group b. One of the researchers and also a statistician is aware of the grouping of geltumps. Both the patient and the dental surgeon who insert the geltamp into the extracted tooth cavity are blind (whether a and b are commercial or manufactured).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Golgasht St, Daneshgah Ave, Tabriz University of Medical Sciences, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2023-11-20, 1402/08/29
Ethics committee reference number
IR.TBZMED.REC.1402.623
Health conditions studied
1
Description of health condition studied
Extraction of the first and second mandibular teeth
ICD-10 code
M27.3
ICD-10 code description
Alveolitis of jaws
Primary outcomes
1
Description
Blood clotting
Timepoint
The amount of bleeding will be recorded after the anesthesia is gone (within 1-4 hours after tooth extraction) and the amount of uncontrollable bleeding after 4 hours will be considered as active bleeding.
Method of measurement
In the study groups, sterile gas is changed every 15 minutes to completely stop the bleeding. The difference in weight of sterile gauze at the beginning and after blood absorption will indicate the amount of blood absorption of each sterile gauze. The number of sterile gauzes consumed and the total weight of sterile blood gauzes absorbed in each group (test and control) will be compared.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: One of the two first or second mandibular of patients in which the production geltamp (a sponge made of gelatin without any drug) will be placed. How to use; In each patient, after extracting the tooth, a production geltamp will be placed in the extracted tooth cavity. Duration of use: It will remain in the place for at least 4 days and after that, it can be discarded or left in the place until complete absorption (10 days).
Category
Prevention
2
Description
Control group: One of the two first or second mandibular of patients in which the commercial geltamp (a sponge made of gelatin without any drug) will be placed. How to use; In each patient, after extracting the tooth, a commercial geltamp will be placed in the extracted tooth cavity. Duration of use: It will remain in the place for at least 4 days and after that, it can be discarded or left in the place until complete absorption (10 days).
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry, Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Ali Ghavimi
Street address
Golgasht St, Daneshgah Ave, Tabriz University of Medical Sciences, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 3161
Email
m_ghavimi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Sameie
Street address
Tabriz University of Medical Sciences, Daneshgah Ave, Golgasht Blvd, Tabriz.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3336 3767
Email
research-vice@tbzmed.ac.ir
Web page address
https://researchvice.tbzmed.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Chancellor for Research and Technology
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
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Ali Ghavimi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tabriz University of Medical Sciences, Daneshgah Ave, Golgasht Blvd, Tabriz.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 3161
Email
m_ghavimi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Solmaz Maleki Dizaj
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Nanotechnology
Street address
Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 3161
Fax
Email
maleki.s.89@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Solmaz Maleki Dizaj
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Nanotechnology
Street address
Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 3161
Fax
Email
maleki.s.89@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
It will be published as a Persian and English article.
When the data will become available and for how long
From the time of publication of the articles onwards.
To whom data/document is available
public
Under which criteria data/document could be used
For use in studies with detailed citations.
From where data/document is obtainable
Dr. Solmaz Maleki
What processes are involved for a request to access data/document