A comparative study of the effect of mouthwashes containing tranexamic acid and nanotransexamic acid for controlSpontaneous intraoral bleeding in leukemia patients: A randomized clinical trial
Determining the effect of mouthwashes containing tranexamic acid and nanotransexamic acid to control spontaneous intraoral bleeding in leukemia patients referred to the dental clinic of Golestan University of Medical Sciences in 1402
Design
Clinical trial with control group, parallel groups, single blind, randomized, phase 3 on 52 patients, Excel software was used for randomization.
Settings and conduct
In this single-blind clinical trial study, the participants were 52 leukemia patients who referred to the oncology unit of the Deziani Clinic of Golestan University of Medical Sciences in 1402, by examining the entry and exit criteria and obtaining informed consent based on the university's code of ethics. will be selected. Patients are randomly assigned to two groups of mouthwash containing tranexamic acid and nanotransamic acid. Patients will be compared pre and post with themselves as well as with other drug group. At first, the patient is asked about the number of oral bleeding times during the day. Then the number of oral bleeding areas is checked by the examiner.Finally, the presence or absence of oral bleeding after using mouthwash will be investigated.
Participants/Inclusion and exclusion criteria
Conditions for entering the study
1-Patients diagnosed with thrombocytopenia
2-Leukemia patients with oral bleeding
3-Similar bleeding frequency
4-Same time interval from chemotherapy
Conditions for withdrawal from the study
1-allergy
2-Pregnant or lactating mother
3-smoking
4-periodontitis
5-Prohibition of anticoagulants
6-Contraceptive pills
7-Use of anticoagulants
Intervention groups
The control group was given mouthwash containing tranexamic acid and the case group was given mouthwash containing nanotransamic acid.
Main outcome variables
Bleeding frequency; presence of bleeding; number of bleeding interdental areas
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230104057046N2
Registration date:2023-03-12, 1401/12/21
Registration timing:prospective
Last update:2023-03-12, 1401/12/21
Update count:0
Registration date
2023-03-12, 1401/12/21
Registrant information
Name
Nazanin Mortazavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3254 5671
Email address
dr.mortazavi@webmail.goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-16, 1401/12/25
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
A comparative study of the effect of mouthwashes containing tranexamic acid and nanotransexamic acid for controlSpontaneous intraoral bleeding in leukemia patients: A randomized clinical trial
Public title
A comparative study of the effect of mouthwashes containing tranexamic acid and nanotrangasemic acid in leukemia patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Leukemia patients with oral bleeding
Patients diagnosed with thrombocytopenia (platelet count less than 20,000 units)
Selection of patients with the same frequency of use as assigned random classification
Selection of patients with the same interval of chemotherapy
Exclusion criteria:
Use of any anti-coagulant or anti-coagulant drugs (such as ASA, NSAID, ...) in the last month
Pregnant or nursing mothers
Hypersensitivity to tranexamic acid
Use of birth control pills
Smokers
Presence of severe periodontitis
The presence of diseases that prohibit the use of anticoagulants
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
We select patients from those who refer to the Desiani clinic of Golestan University of Medical Sciences according to the study entry and exit criteria. Then, based on the severity of the disease, we divide them into two groups, moderate and weak, and enter the names in a double list (in the form of a and b) in the Excel software. Then, the names are sorted separately based on random numbers for each list, and assigned to each of the drug groups one by one.
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants are unaware of the allocation of study groups. Bottles containing medicine are the same for both control and intervention groups. The intervention and control groups are divided into A and B, and the test participants have no knowledge of the type and group to be tested.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Golestan University of Medical Sciences
Street address
Philosophical Higher Education Complex، the beginning of the Sixty Hats Road، Gorgan
City
Gorgan
Province
Golestan
Postal code
49341-74515
Approval date
2023-01-17, 1401/10/27
Ethics committee reference number
IR.GOUMS.REC.1401.556
Health conditions studied
1
Description of health condition studied
Spontaneous oral bleeding in leukemia patients
ICD-10 code
C95
ICD-10 code description
Leukemia of unspecified cell type
Primary outcomes
1
Description
The number of times of spontaneous oral bleeding؛ the presence of spontaneous oral bleeding؛ the number of bleeding interdental areas after using an interdental toothbrush by the researcher
Timepoint
Measuring the number of bleeding interdental areas before the start of the intervention and 14 days after the start of the intervention؛ Measuring the number of bleeding times before and after using mouthwash (every day up to two weeks)؛ Identifying the presence of oral bleeding before and after using mouthwash (every day up to two weeks )
Method of measurement
Evaluation of the presence of bleeding by questionnaire - Evaluation of the number of bleeding areas by the researcher through interdental toothbrushes - Evaluation of the number of bleeding times by questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group The intervention group receives five percent nanotrangasmic acid mouthwash. Each subject will receive 4 containers of 280 ml containing mouthwash. Each patient is taught to use 20 ml mouthwash four times a day for 14 days. The participant is allowed to eat half an hour after using the mouthwash. The mouthwashes are made by pharmacists and experts in the nano field who are present as consultants in the project.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Deziani Hospital of Medical Sciences
Full name of responsible person
Dawood Mozaffari
Street address
Collection of higher philosophical education, The beginning of the Sixty Hats Road
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 903 747 8270
Email
aliyesensebli@gmail.com
Web page address
http://goums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Narges Begum Mirbehbani
Street address
Dental Research Center، Gorgan Dental College، Shahreer five، Shahryar townl
City
Gorgan
Province
Golestan
Postal code
4913983635
Phone
+98 17 3262 8052
Email
aliyesensebli@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan 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
Gorgan University of Medical Sciences
Full name of responsible person
Aliye sensebli
Position
Dentistry student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Makhtumaghli 24، Attaabad,
City
Gorgan
Province
Golestan
Postal code
4938134820
Phone
+98 17 3450 2115
Email
aliyesensebli@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Nazanin Mortazavi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shahrear 5، Shahrear town
City
Gorgan
Province
Golestan
Postal code
4938134820
Phone
+98 17 3450 2115
Email
dr.mortazavi@webmail-goums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Aliye sensebli
Position
Dentistry student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Makhtoumaghli 24، Ataabad
City
Gorgan
Province
Golestan
Postal code
4938134820
Phone
+98 17 3450 2115
Email
aliyesensebli@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be 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
Potential data can be shared after de-identifying individuals.
When the data will become available and for how long
The access period starts six months after the publication of the results
To whom data/document is available
Researchers working in academic and scientific institutions in the country can access the data and other documents of this study with a written request from (Gorgan Dental School Research Center).
Under which criteria data/document could be used
The documents will be made available to the applicants after obtaining permission from the project promoters and the research director of Golestan University of Medical Sciences and with a written request from (Research Center of Gorgan Dental School). Obviously, it takes time during the administrative procedures, and we try to do it within a month from the date of the request.
From where data/document is obtainable
Gorgan, Shahrek Shahryar, 5 Shahryar, Gorgan Dental College, Dental Research Center, Mrs. Shabani, Research Center Expert, Postal Code 4913983635, Phone Number 28853262017, Email s.shabani8791@gmail.com
What processes are involved for a request to access data/document
Researchers working in academic and scientific institutions in the country can access the data and other documents of this study by making a written request from (Gorgan Dental Faculty Implementation Center). The documents will be available to the applicants after obtaining the permission from the project managers and the research director of Golestan University of Medical Sciences. Obviously, the administrative procedures take time and we try to do it within a month from the date of the request.