The practical purpose of this study was to introduce probiotic mouthwash as one of the effective treatments in oral mucositis ulcers .
Design
Randomized clinical trial with parallel groups, double-blind, phase 2 on 64 patients, Excel software rand function was used for randomization
Settings and conduct
In both groups, in addition to the usual treatment of mucositis, probiotic and normal saline mouthwash is started 1 day before the start of radiotherapy. The patient gargles mouthwash three times a day
for 3 minutes. The patient and the distributor of mouthwash do not know the type of mouthwash used. Clinical care is provided at Imam Khomeini Hospital.
Participants/Inclusion and exclusion criteria
all patients needed head and neck radiotherapy at imam khomeini hospital are eligible for the study.
Intervention groups
During radiotherapy, every 3 days for 6 weeks, patients are examined for mucositis by an examination by ِDr specialist in oral medicine, and the patient's mucosal grade is determined by a clinical examination by Dr specialist in oral medicine
Main outcome variables
The sampling process will take time and the study will be long.
The main expected outcome is the positive effect of probiotic mouthwash on patients' oral mucosa.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201106049288N1
Registration date:2020-12-23, 1399/10/03
Registration timing:prospective
Last update:2020-12-23, 1399/10/03
Update count:0
Registration date
2020-12-23, 1399/10/03
Registrant information
Name
Zahra Mofazzal jahromi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2249 0860
Email address
zahramofazzal@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-20, 1399/11/01
Expected recruitment end date
2021-07-23, 1400/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparision of the effect of probiotics mouthwash and normal saline in the treatment of radiotherapy induced mucositis
Public title
Effect of probiotics mouthwash and normal saline in treatment of mucositis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
all patients needed head and neck radiotherapy at imam khomeini hospital .
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
A simple randomization method is used.
For randomization, randomly selected pre-radiotherapy use is selected for inclusion in the study.
The first step in performing a random process is to create a random sequence.
The second step after creating a random sequence is sequencing generating technology (property privatization acquisition).
The purpose of these steps is to prevent any predictions of future allocation by drug sales and distribution companies.
Both groups compete with each other using age and gender, and the age of the people in the case group is controlled by the average age of the people in the control group, and thus matching between the two groups takes place.
Blinding (investigator's opinion)
Double blinded
Blinding description
In addition to the patient, the person giving the mouthwash to the patient does not know the type of mouthwash.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the School of Dentistry, Tehran University of Medical Sciences
Street address
Khani Abad No - Shahid Zolfi St. (Mahan) - Opposite Shariati Park - School of Dentistry
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2020-12-19, 1399/09/29
Ethics committee reference number
IR.TUMS.DENTISTRY.REC.1399.176
Health conditions studied
1
Description of health condition studied
Radiotherapy-induced oral mucositis
ICD-10 code
K00-K14
ICD-10 code description
بیماریهای حفره دهانی، غددبزاقی و فک ها
Primary outcomes
1
Description
The effect of mouthwash on mucositis
Timepoint
Once every 3 days for 6 weeks
Method of measurement
Mucosite grading
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Probiotic mouthwash is used to prepare probiotic mouthwash from Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus rhamnosus, Lactobacillus salivarius, Lactobacillus ruteri, Bifidobacterium lactobacillus, Bactidobacterium lactobacillus, The combination of bacteria is prepared in powder form and is provided to the therapist and the patient as a pre-prepared solution.
Category
Treatment - Drugs
2
Description
Intervention group: To prepare normal saline mouthwash from Tween 80 (500 mg), 5 (Avicel g) and xanthan (2 g), methyl paraben (8.1 g), propyl paraben (200 mg), disodium hydrogen phosphate (2 g), sodium dihydrogen phosphate (3 g) and distilled water are used.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
بیمارستان امام خمینی
Full name of responsible person
دکتر سهیلا مانی فر
Street address
بزرگراه چمران، خیابان باقرخان، انتهای بلوار کشاور ، مجتمع بیمارستان امام خ