Evaluation of nuclear changes (karyorexis, karyolysis, micronucleus, broken egg) of buccal mucosal cells after one week of using chlorhexidine mouthwash.
Design
Study of goal-based clinical trial, historical cohort, single, non-blind, non-random, phase 2-3 on 50 patients, before and after
Settings and conduct
To collect data from the interview technique, questions were asked to patients referred to the periodontology department of Tehran Azad Dental School along with completing the information form and sampling with wet swab from the buccal mucosa before and after one week of using chlorhexidine mouthwash and study by light microscopy Will be used after painting
Participants/Inclusion and exclusion criteria
50 people with gingivitis who have referred to the Dental Periodontics Unit of Azad University for scaling; No entry of smokers with a history of more than 5 years and more than 20 cigarettes per day that are considered Heavy Smoker; Retroviral, statins containing statins, ..; and no drug addiction; and no employment in high-risk jobs such as the paint industry, etc .; no recent viral disease; Lack of radiation therapy
Intervention groups
Chlorhexidine mouthwash ٪0.2;250 ml;Najoo Co.
Main outcome variables
Micronucleus، karyorrhexis،karyolysis ,broken egg ,Repair Index,before and after using chlorhexidine mouthwash
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180714040460N7
Registration date:2021-03-03, 1399/12/13
Registration timing:prospective
Last update:2021-03-03, 1399/12/13
Update count:0
Registration date
2021-03-03, 1399/12/13
Registrant information
Name
Nima Nadafpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 4571
Email address
n_nadaf@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-04, 1400/01/15
Expected recruitment end date
2021-06-05, 1400/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the relationship between chlorhexidine mouthwash and nuclear changes in buccal mucosa in people with gingivitis
Public title
Evaluation of carcinogenicity of chlorhexidine mouthwash on oral mucosa
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Be in the treatment of phase one gingivitis
be between 20-30 years old
Have gingivitis
Exclusion criteria:
The smoking group includes samples with a history of consumption of more than 5 years and above 20 cigarettes per day that are considered Heavy Smoker
criteria for taking certain drugs (such as antiretrovirals, doses containing statins, ..)
Drug addiction
engaging in high-risk occupations such as the paint industry, etc
recent viral illness
Undergoing radiotherapy or Less than one year history for radiotherapy
Age
From 30 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
More than 1 sample in each individual
Number of samples in each individual:
2
Sampling with wet water sling from the buccal mucosa of people before and after one week of using chlorhexidine mouthwash
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
Faculty of Dentistry, Islamic Azad University, Tehran Branch
Street address
No. 9, Neystan Alley, Pasdaran St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
19585157
Approval date
2019-06-01, 1398/03/11
Ethics committee reference number
IR.IAU.DENTAL.REC.1398.011
Health conditions studied
1
Description of health condition studied
Carcinogenic effect of chlorhexidine mouthwash
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Micronucleus
Timepoint
Before scaling and one week after using chlorhexidine mouthwash
Method of measurement
Cell count with light microscope with 400 magnification
2
Description
Karyorrehxis
Timepoint
Before scaling and one week after using chlorhexidine mouthwash
Method of measurement
count with light microscope with 400 magnification
3
Description
Karyolysis
Timepoint
Before scaling and one week after using chlorhexidine mouthwash
Method of measurement
count with light microscope with 400 magnification
4
Description
Broken egg
Timepoint
Before scaling and one week after using chlorhexidine mouthwash
Method of measurement
count with light microscope with 400 magnification
5
Description
Repair index
Timepoint
It is calculated after counting nuclear changes
Method of measurement
Mean karyolysis and karyorexia divided by the mean of micronucleus and Broken ag
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: To evaluate the toxicity of chlorhexidine mouthwash and to diagnose its carcinogenicity, chlorhexidine mouthwash 0/2٪ 250 ml has been prepared by Najo Company and is supposed to refer to 50 patients of who refer to the periodontology department of Azad University of Tehran . Phase one should be treated by rinsing your mouth thoroughly with water before scaling, and a layer of cells is removed from the surface of the buccal mucosa of the mouth with a wet swab and applied to a clean, sterile slide. The slide is placed, then we fix it with spray fix, and then the mouthwash is rotated twice a day and night after brushing, each time 10 ml of solution,by time 30 seconds ,turned in mouth and Then emptied. The second session of treatment, which is one week later, will take the second sample . both samples after the steps of Pap smear and fixation and nucleus staining and dehydration, we will count nuclear changes of micronucleus, karyorexis, karyolysis and broken eggs with light microscopy.then we can judge the result.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Periodontology, Tehran Azad School of Dentistry