Comparison of Gelfoam and Bonehem in dental socket bleeding control in patients on low-dose Aspirin
Design
A clinical trial with a control group, with parallel groups, double-blinded, randomized, phase 2 on 30 patients. A table of random numbers was used for randomization.
Settings and conduct
After approval by the Research Council of Shahid Beheshti Dental School, randomization will be done among the patients eligible to participate in the study, and they will be randomly divided into 3 groups. The study will be double-blinded in all three groups (patients and researchers are blinded). After tooth extraction, a method of hemostasis will be used based on each group, and post-treatment recommendations will be provided. the number of sterile gauze used after the treatment will show the results.
Participants/Inclusion and exclusion criteria
Inclusion criteria: healthy patients between the ages of 30 and 75 with ASA I-II treated with one 80 mg aspirin tablet daily who are candidates for non-surgical extraction of mandibular first or second molar teeth.
Exclusion criteria: patients using other doses or different amounts of aspirin, using other anticoagulant drugs along with aspirin, candidate for socket preservation; with contraindications to use Bonehem (areas with infection) and Gelfoam (known allergy to porcine collagen); with wound healing disorders, with bone diseases, diagnosed with diabetes mellitus; diagnosed with autoimmune diseases; candidates for surgical tooth extraction, candidates for immediate implant placement.
Intervention groups
1: Patients in whom Gelfoam is used to control bleeding from the tooth socket.
2: Patients in whom Bonehem is used to control bleeding from the tooth socket.
3: patients in whom a figure-of-eight suture is used to control bleeding from the tooth socket.
Main outcome variables
Dental socket bleeding post-tooth extraction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221220056881N1
Registration date:2022-12-30, 1401/10/09
Registration timing:registered_while_recruiting
Last update:2022-12-30, 1401/10/09
Update count:0
Registration date
2022-12-30, 1401/10/09
Registrant information
Name
Mohammad Hassan Mirtaleb
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2270 1377
Email address
mirtalebmohamad@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2023-06-22, 1402/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Gelfoam and Bonehem in dental socket bleeding control in patients on low-dose Aspirin
Public title
Effect of Bonehem in Hemostasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy patients (ASA I/II)
Under treatment with a single 80mg dose of Aspirin tablet daily
Candidate for non-surgical removal of mandibular first and second molar teeth
Exclusion criteria:
Age
From 30 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
People are randomly allocated to one of the three study groups using a random number and receive the intervention based on the group. First, a random number is allocated to each group; Coefficients of the number 3 are allocated to the first group, coefficients of 3 plus 1 are allocated to the second group, and coefficients of 3 plus 2 are allocated to the third group. For the distribution of the patients to each group, first, the direction of reading the numbers from the table is determined and then the researcher touches one of the numbers randomly and moves in one of the predetermined directions and records the numbers, and assigns the patient to the specified group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study will be double-blinded. Patients are blinded to the type of intervention, and the researcher who has to enter the data into the checklist will be blinded to the type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences Ethics Committee
Street address
Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd., Evin, Chamran Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2022-11-14, 1401/08/23
Ethics committee reference number
IR.SBMU.DRC.REC.1401.070
Health conditions studied
1
Description of health condition studied
Bleeding after extraction of mandibular first and second molar teeth
ICD-10 code
T81.0
ICD-10 code description
Haemorrhage and haematoma complicating a procedure, not elsewhere classified
Primary outcomes
1
Description
socket haemorrhage
Timepoint
24 hours after tooth extraction
Method of measurement
number of sterile gauze required to stop bleeding after tooth extraction
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: a single Gelfoam (Surgifoam, Ethicon) is used on the dental socket after extraction without suturing the socket. A 10x10 sterile gauze is then placed on the socket and the patient is guided to slowly bite on the gauze.
Category
Treatment - Drugs
2
Description
Intervention group: a single Bonhem (from Chitotech company, based on hydroxyapatite and bioglass) is used on the dental socket after extraction without suturing the socket. A 10x10 sterile gauze is then placed on the socket and the patient is guided to slowly bite on the gauze.
Category
Treatment - Drugs
3
Description
Control group: A 3-0 silk (Supasil) figure-of-eight suture is used to suture the dental socket after extraction. A 10x10 sterile gauze is then placed on the socket and the patient is guided to slowly bite on the gauze.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Dental School
Full name of responsible person
Doctor Fateme Latifi
Street address
Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd., Evin, Chamran Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2217 5350
Email
info@sbmu.ac.ir
Web page address
https://dentistry.sbmu.ac.ir
2
Recruitment center
Name of recruitment center
Behfar Dental Clinic
Full name of responsible person
Shiva Reyvandi
Street address
Damavand Street, Tehran
City
Tehran
Province
Tehran
Postal code
1644914989
Phone
+98 21 7781 3948
Email
info@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
ChitoTech
Full name of responsible person
Ms. Mohammadi
Street address
Units 9 and 11, Khaghani Building,No 83، Somayyeh street ,Tehran
City
Tehran
Province
Tehran
Postal code
1571838318
Phone
+98 21 8832 1518
Email
info@chitotech.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
ChitoTech
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Hassan Mirtaleb
Position
Dental Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd., Evin, Chamran Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2217 5350
Email
mirtalebmohamad@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Doctor Fateme Latifi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shahid Beheshti Dental School, Daneshjoo Blvd., Evin, Chamran Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2990 2307
Email
dr.f.latifi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Hassan Mirtaleb
Position
Dental Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
hahid Beheshti Dental School, Daneshjoo Blvd., Evin, Chamran Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2217 5350
Email
mirtalebmohamad@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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
Related medical information, clinical information, results of the study
When the data will become available and for how long
Approximately 6 months after publishment
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
More detailed information about the study can be provided to competent researchers interested in the subject of the study
From where data/document is obtainable
Author (Mohammad Hassan Mirtaleb) via email: mirtalebmohamad@gmail.com
What processes are involved for a request to access data/document
Competent and enthusiastic researchers can receive data documentation after the publication of the work from the corresponding author by providing their academic information and identification.