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Evaluation of the effect of X-ray in CBCT imaging on the rate of nuclear changes and Repair Index of buccal mucosal cells

Protocol summary

Study aim
Determining the effect of X-ray exposure in CBCT imaging on nuclear changes and buccal mucosal cell repair in patients referred to the Department of Oral and Maxillofacial Radiology, Tehran Azad University in 1401
Design
Clinical trial without a control group, phase 2 on 60 patients to evaluate the effect before and after
Settings and conduct
The buccal mucosal cells are shaved with a damp spatula from the buccal mucosa adjacent to the imaging site, and these cells are spread on clean slide glass slides. Slides are allowed to air dry at room temperature. After sampling, CBCT is prepared for patients. CBCT images will be provided. The sample will be taken immediately before exposure and 10 days after imaging. Papanicolaou staining is then used to measure micronuclei and other nuclear changes, and observation will be performed with a light microscope.
Participants/Inclusion and exclusion criteria
Adults 18 to 45 years of age who have not had radiotherapy in the past 28 days, do not use cigarettes or mouthwash containing alcohol, are not currently receiving medical treatment, and not taking medications such as immunosuppressants, anti-inflammatory drugs, corticosteroids, antivirals, etc. Patients must not have systemic diseases that affect the oral mucosa, such as viral diseases, lichen planus, pemphigus, Sjogren's syndrome, Reiter, Behcet, lupus, scleroderma, etc.
Intervention groups
X-ray produced during CBCT imaging
Main outcome variables
Specific target variables 1: Micronucleus, Karyorrhexis, Karyolysis, Broken egg, Repair index before radiation exposure in CBCT imaging by sex and FOV Specific target variables 2: Micronucleus, Karyorrhexis, Karyolysis, Broken egg, and Repair Index after exposure to radiation in CBCT imaging by sex and FOV

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220418054582N1
Registration date: 2022-05-30, 1401/03/09
Registration timing: registered_while_recruiting

Last update: 2022-05-30, 1401/03/09
Update count: 0
Registration date
2022-05-30, 1401/03/09
Registrant information
Name
parissa shahmohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 4573
Email address
parissashahmohammadi91@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-22, 1401/03/01
Expected recruitment end date
2023-02-20, 1401/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of X-ray in CBCT imaging on the rate of nuclear changes and Repair Index of buccal mucosal cells
Public title
Evaluation of the effect of X-ray in CBCT imaging on the rate of nuclear changes and Repair Index of buccal mucosal cells
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adults 18 to 45 years old who have come to the university for a CBCT scan.
Exclusion criteria:
Perform radiotherapy in the last 28 days Smoking and mouthwash containing alcohol Existence of systemic disease Taking effective drugs in the oral mucosa
Age
From 18 years old to 45 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 60
More than 1 sample in each individual
Number of samples in each individual: 2
before and after
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University of Tehran
Street address
No 9, 9th Neyestan, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946853314
Approval date
2022-04-13, 1401/01/24
Ethics committee reference number
IR.IAU.DENTAL.REC.1401.007

Health conditions studied

1

Description of health condition studied
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The extent of micronucleus changes after X-ray exposure in CBCT imaging
Timepoint
At the beginning of the study (before exposure) and 10 days after exposure
Method of measurement
Observation with a light microscope

2

Description
The extent of Karyorrhexis changes after X-ray exposure in CBCT imaging
Timepoint
At the beginning of the study (before exposure) and 10 days after exposure
Method of measurement
Observation with a light microscope

3

Description
The extent of Karyolysis changes after X-ray exposure in CBCT imaging
Timepoint
At the beginning of the study (before exposure) and 10 days after exposure
Method of measurement
Observation with a light microscope

4

Description
The extent of Broken egg changes after X-ray exposure in CBCT imaging
Timepoint
At the beginning of the study (before exposure) and 10 days after exposure
Method of measurement
Observation with a light microscope

5

Description
The extent of Repair Index changes after X-ray exposure in CBCT imaging
Timepoint
At the beginning of the study (before exposure) and 10 days after exposure
Method of measurement
Calculate according to the formula

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: X-ray exposure
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of Oral and Maxillofacial Radiology, Islamic Azad University of Tehran
Full name of responsible person
Parissa Shahmohammadi
Street address
No 9, 9th Neyestanm, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
parissashahmohammadi91@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ahmadreza Talaipour
Street address
No 9, 9th Neyestan, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
ar_talai@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Parissa Shahmohammadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No 9, 9th Neyestan, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
parissashahmohammadi91@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Parissa Shahmohammadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No. 9, 9th Neystan , Pasdaran St
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
parissashahmohammadi91@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Parissa Shahmohammadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No. 9, 9th Neystan, Pasdaran St.
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
parissashahmohammadi91@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
Undecided - It is not yet known if there will be 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
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
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