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Comparative Evaluation of the effect of tranexamic acid impregnated gauze with gelatamp in controlling bleeding after the extraction of four maxillary primary incisors in children candidates for dental treatment under general anesthesia

Protocol summary

Study aim
Comparative Evaluation of the effect of tranexamic acid impregnated gauze with gelatamp in bleeding control
Design
Randomized cross over trial on 30 patient, double-blind, This study will be conducted in a double-blind manner so that the examining clinician and data analyst will not know the type of intervention.
Settings and conduct
Children candidates for dental treatment under general anesthesia who refer to the hospital dental department of Isfahan Faculty of Dentistry during the study, if they are eligible, will be included in the study and will be randomly divided with the help of a random number table.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: The need to Extract Primary incisors, Age 2 to 4 years, The Studied Teeth should have less than One-third root resorption and unmaintainable crowns, The Child under Study only needs to have four Primary incisors Extracted and no other teeth should be Extracted from the Patient If the Tooth is not infected and the root has not Decayed to a large extent, it is included in the study Exclusion Criteria: History of any uncontrolled systemic disease, Patients whose parents do not consent to participate in the study for any reason
Intervention groups
Intervention group 1: Gelatamp, two pieces of gelatamp (Spongostan, Ferrosan, Denmark) will be placed half inside the socket. Intervention group 2: Tranexamic acid-impregnated gauze, 2x2 gauze impregnated with 4cc of Tranexamic acid ampoule (Tranexip, Caspian Tamin, Iran) with a dose of 500 mg/5 ml will be applied to two adjacent teeth.
Main outcome variables
Intensity of Bleeding, Bleeding Time

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210419051016N3
Registration date: 2023-06-17, 1402/03/27
Registration timing: retrospective

Last update: 2023-06-17, 1402/03/27
Update count: 0
Registration date
2023-06-17, 1402/03/27
Registrant information
Name
Maryam Hajiahmadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3266 2236
Email address
dr.maryamhajiahmadi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-16, 1402/01/27
Expected recruitment end date
2023-06-17, 1402/03/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Evaluation of the effect of tranexamic acid impregnated gauze with gelatamp in controlling bleeding after the extraction of four maxillary primary incisors in children candidates for dental treatment under general anesthesia
Public title
Comparative Evaluation of the effect of tranexamic acid impregnated gauze with gelatamp in controlling bleeding
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The need to Extract Primary incisors Age 2 to 4 years Children are not affected to Congenital Hemorrhagic Diseases Children should not receive Anticoagulants The Child does not have a Mental or Physical Disability The Studied Teeth should have less than One-third root Resorption and unmaintainable Crowns Do not take Ibuprofen and Aspirin Painkillers before and after work The Child does not have Contraindications for General Anesthesia The Studied Child only needs to have four Primary incisors Extracted and another Tooth Extracted from the Patient If the Tooth is not Infected and the root has not Decayed to a large extent, it is included in the Study If They do not have Complications during General Anesthesia. (Hypoxia, Blood Pressure drop, Larynx Spasm, etc.)
Exclusion criteria:
History of any uncontrolled systemic disease Patients whose parents do not consent to participate in the study for any reason
Age
From 2 years old to 4 years old
Gender
Both
Phase
3
Groups that have been masked
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Children who are candidates for extraction of primary teeth who refer to the hospital dental department of Isfahan Faculty of Dentistry during the study, if they are eligible, will be included in the study and will be randomly assigned by simple randomization method and individually with the help of a table of random numbers; In this method, the 'AB' order is considered for each odd number, and the 'BA' order is considered for each even number. Then a column is randomly selected from the table and if the first selected number is odd, the 'AB' order is applied which means the first patient is allocated in the A group and receives GELATAMP treatment, and as a result, the next patient is allocated to the B group and receives TRANEXAMIC ACID IMPREGNATED GAUZE treatment. Similarly, If the selected number is even, the 'BA' order is applied and the first patient is allocated in the B group and receives TRANEXAMIC ACID IMPREGNATED GAUZE treatment, and as a result, the next patient is allocated to the A group and receives GELATAMP treatment. This is repeated 15 times until you get 15 samples in each group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Outcome assessor was not aware of the type of material used for each tooth while evaluating the treated teeth clinically and radiographically. This study will be conducted in a double-blind manner so that the examining clinician and data analyst will not know the type of intervention.
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Ground Floor, Faculty of Medicine, Building No. 3, Isfahan University of Medical Sciences,Hezar Jerib St., Isfahan , Phone number: 03137923080
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2023-03-18, 1401/12/27
Ethics committee reference number
IR.MUI.RESEARCH.REC.1401.433

Health conditions studied

1

Description of health condition studied
Tranexamic Acid, Controlling Bleeding, Gelatamp
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Intensity of Bleeding
Timepoint
The determined time intervals are 10, 5, and 15 minutes after starting to use Gelatamp and gauze impregnated with Tranexamic acid
Method of measurement
Fanning scale

2

Description
Bleeding Time
Timepoint
The determined time intervals are 10, 5, and 15 minutes after starting to use Gelatamp and gauze impregnated with Tranexamic acid
Method of measurement
Fanning scale

Secondary outcomes

1

Description
Oral Health
Timepoint
At the beginning of the study (before the start of the intervention) and Two weeks after the end of the intervention
Method of measurement
Examination of the child's mouth

Intervention groups

1

Description
The first intervention group: Gelatamp, after extraction for two teeth, two pieces of Gelatamp (Spongostan, Ferrosan, Denmark) will be placed half inside the socket and after a period of 4 weeks in the second phase of the study, the groups will be changed.
Category
Treatment - Other

2

Description
The second intervention group: Tranexamic acid impregnated gauze, a gauze with dimensions of 2 x 2, impregnated with 4cc of ampoule of tranexamic acid (Tranexip, Caspian Tamin, Iran) with a dose of 500 mg/5 ml will be applied to two similar teeth and after a period of 4 weeks in the second phase of the study, the groups will be changed.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of Hospital Dentistry, Faculty of Dentistry, Isfahan
Full name of responsible person
Dr.Maryam Hajiahmadi
Street address
Hospital Dental Department, Isfahan Faculty of Dentistry, Isfahan University of Medical Sciences and Health Care Services, Hazar Jarib St.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5539
Email
dr.maryamhajiahmadi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Asgari
Street address
Building No.4, Isfahan University of Medical Sciences, Hezar Jerib St.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 3060
Email
askari@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Maryam Hajiahmadi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Pediatric Dentistry department, Faculty of Dentistry, Isfahan University of Medical Sciences, Hezar jerib St.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5539
Email
dr.maryamhajiahmadi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Maryam Hajiahmadi
Position
Assistant Professor, University faculty
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Isfahan University of Medical Sciences, Hezar Jerib St., Isfahan
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶-۷۳۴۶۱
Phone
+98 31 3792 5539
Email
dr.maryamhajiahmadi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Maryam HajiAhmadi
Position
Assistant Professor, University faculty
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Isfahan University of Medical Sciences, Hezar Jerib St., Isfahan.
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶-۷۳۴۶۱
Phone
+98 31 3792 5539
Email
dr.maryamhajiahmadi@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
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
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The patient's personal details are not required
When the data will become available and for how long
The access period starts 6 months after the results are published.
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
In case of research on a similar subject, they can use the data of this research
From where data/document is obtainable
Correspondance with Dr. HajiAhmadi via e-mail dr.maryamhajiahmadi@gmail.com
What processes are involved for a request to access data/document
Correspondance with Dr. HajiAhmadi via e-mail and documents will be sent if she agrees
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