Investigating the effect of pomegranate skin mouthwash on oral hygiene and bacterial colonization of oral and tracheal intubated patients admitted to the intensive care units(ICUs)
Determining the effect of pomegranate peel extract
Design
Clinical trial with a control group, with parallel groups,single-blind, randomized, phase 2 on 80 patients. A table of random numbers was used for randomization
Settings and conduct
After making the necessary arrangements, the researcher will go to the intensive care units (ICU) of the teaching hospitals of Zahedan University of Medical Sciences. The 80 anesthetized patients hospitalized in the intensive care units will be divided into two intervention groups (40 people) and control groups (40 people). Evaluation of oral and dental health It will be measured using Beck's assessment scale (BOAS) and oral mucosal plaque score (MPS). Mouth care and washing in the patients of the intervention group using 0.2% chlorhexidine mouthwash and 0.2% pomegranate peel extract by the researcher and in the control group patients by the researcher according to the routine of the ICU department using 0.2% chlorhexidine mouthwash and mouthwashes in both groups twice a day It is used for patients with an interval of 12 hours and for 4 days. In order to determine the relationship between the growth rate of bacterial colonization in the mouth and tracheal tube in patients using chlorhexidine mouthwash and pomegranate peel extract, the culture will be sent to the laboratory on the first and fourth day.
Participants/Inclusion and exclusion criteria
Patients with a tracheal tube and a level of consciousness of 3 to 7 on the GCS scale
Age 18 to 65 years
Intervention groups
The intervention group of mouthwash with pomegranate peel extract and the control group of chlorhexidine mouthwash
Main outcome variables
Bacterial colonization rate of tracheal tube of intubated patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230513058170N1
Registration date:2023-06-20, 1402/03/30
Registration timing:registered_while_recruiting
Last update:2023-06-20, 1402/03/30
Update count:0
Registration date
2023-06-20, 1402/03/30
Registrant information
Name
Marzieh Saravani Pak
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3341 3973
Email address
mehdi.rezvaniamin@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of pomegranate skin mouthwash on oral hygiene and bacterial colonization of oral and tracheal intubated patients admitted to the intensive care units(ICUs)
Public title
Investigating the effect of pomegranate skin mouthwash on oral hygiene and bacterial colonization of oral and tracheal intubated patients admitted to the intensive care units(ICUs)
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Intubated patients admitted to the special care department of teaching hospitals in Zahedan
- Patients with a tracheal tube and a level of consciousness of 3 to 7 on the GCS scale
2- Age 18 to 65 years
3- 24 hours have passed since the admission or hospitalization of the patient
4- Having natural teeth in the patient
5- Not having a history of allergy to pomegranate
6- Absence of a specific lesion in the mouth
7- The patient should not have radiotherapy experience
8- Willingness of the patient's legal guardian to continue participating in the study
9- Obtaining oral health evaluation checklist score less than 16.
Exclusion criteria:
- Airway damage during intubation
2- Pneumonia as an inpatient diagnosis
3- History of allergy to used mouthwash, asthma, allergic rhinitis and skin inflammation
4- Signs of sensitivity to mouthwash, such as redness, urticaria, and sores inside the mouth
5- Transfer of the patient from ICU or his death before the completion of the research
Age
From 18 years old to 65 years old
Gender
Both
Phase
1-2
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
80
More than 1 sample in each individual
Number of samples in each individual:
40
The sample size was estimated with 80% power and 95% confidence level (significance level 0.05) based on the following formula, 40 people in each group and 80 people in total
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling is based on the entry criteria and is selected in an available manner, and then the random number table will be used for the random allocation of patients in such a way that for each person from the sample, a point will be determined on the random number table using a pen tip, and then We move from right to left and a number will be selected from the table of random numbers. If even and zero digits are obtained, the person will be in the intervention group, and if odd numbers are obtained, the person will be placed in the control group
Blinding (investigator's opinion)
Single blinded
Blinding description
Single-blind clinical trial - in such a way that blinding will be done for the laboratory expert , for this purpose, the samples collected by the researcher will be provided to the laboratory in the same containers with the same label and code, and the laboratory official will not be aware of the type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Sciences
Street address
Zahedan, 62 Jam Jam St., Milan II, on the right side of the third door
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9814745413
Approval date
2023-05-14, 1402/02/24
Ethics committee reference number
IR.ZAUMS.REC.1402.056
Health conditions studied
1
Description of health condition studied
Investigating the effect of pomegranate peel extract mouthwash on oral hygiene
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The bacterial colonization status of the tracheal tube of intubated patients
Timepoint
on the first day (before admission of patients) and on the fourth day in the ICU department
Method of measurement
Beck's measurement scale - oral mucosal plaque score - culture from Score obtained from the scale (MPS) = 2-4 a unacceptable MPS = 7-8 weak, the score received every day on the scale (BOAS). Number 5 no disorder, 6-10 mild disorder, 11-15 moderate disorder, 16-20 severe disorde،Cultivation on the first day (before admission of patients) and the fourth day in the ICU departmentmouth and tracheal tube
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group-preparation of pomegranate peel extract from Adonisgol Daru Company-Tehran, has an international approval and certificate. Pomegranate peel extract with a concentration of 0.2% is administered twice a day at an interval of 12 hours (9-21) for four days, before the intervention. The entire surface of the mouth, gums, tongue, pharynx, and tooth surfaces is carefully brushed with a soft children'stoothbrush, and the remaining secretions in the throat and mouth are suctioned with a sterile green Nalaton catheter in less than 30 seconds. . The whole process of cleaning the mouth and washing takes 6 minutes.
Category
Prevention
2
Description
Control group: chlorhexidine mouthwash 0.2% - according to the routine of the ICU department using 0.2% chlorhexidine mouthwash, which is done twice a day every 12 hours (9-21) for four days, before the intervention. The entire surface of the mouth, gums, tongue, pharynx, and tooth surfaces is carefully brushed with a soft children'stoothbrush, and the remaining secretions in the throat and mouth are suctioned with a sterile green Nalaton catheter in less than 30 seconds. . The whole process of cleaning the mouth and washing takes 6 minutes.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Teaching hospitals of Zahedan University of Medical Sciences
Full name of responsible person
Dr. Mehdi Rizvani Amin
Street address
Behdasht Street-Mashahir Bivd-Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
05433442481
Phone
+98 54 3344 2481
Email
Mehdi.rezvaniamin@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Mehdi Rizvani Amin
Street address
Behdasht Street-Mashahir Bivd-Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
00985433442481
Phone
+98 54 3344 2481
Email
Mehdi.rezvaniamin@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Marzieh Saravani Pak
Position
Special care master nursing student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.34 JamJamStreet62 ThreeAlley
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9814745413
Phone
+98 54 3328 9758
Email
msaravanipak@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Mehdi Rizvani Amin
Position
science Committee
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Behdasht Street-Mashahir Bivd-School of Nursing and Midwifery
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
05433442481
Phone
+98 54 3344 2481
Email
Mehdi.rezvaniamin@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Marzieh Saravani Pak
Position
Master of Special Care Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.34 JamJamStreet62 ThreeAlley
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9814745413
Phone
+98 54 3328 9758
Email
msaravanipak@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