The comparison of the effect of chlorhexidine and combination of cholorhexidine-persica mouthwashes on chemotherapy-induced mucositis of children with hematologic malignancies
The purpose of this study is to compare the effect of chlorhexidine mouthwash with combination of cholorhexidine-persica mouthwash on chemotherapy-induced mucositis of children with hematomalignancies. Six to 12 year old children with hematomalignancy who are under a similar treatment protocol will be enrolled in the study. Children who demonstrate infection or sensitivity following the administration of any of the mouth-rinses will be excluded. Accordingly, 40 patients selected will be randomly assigned to one of two experimental groups after obtaining the appropriate informed consent. Randomization will be performed using the www.randomizer.org website. Oral hygiene cares will be instructed by the clinician to all of the patients and their parents. The incidence and severity of the mucositis will be evaluated by using a questionnaire designed based on the World Health Organization (WHO) index for incidence and severity of mucositis and Oral Assessment Guide (OAG) index for severity of mucositis. Then, the patients will be instructed to rinse either with normal saline (15 ml) or persica oral drops (10 drops in 15 ml water), based on their corresponding group, twice a day for two weeks. Subsequently, patients in both groups will rinse with 15 ml of chlorhexidine for 30 seconds and avoid eating for an hour. A second oral examination will be performed on the 8th and 15th day using the same questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014060117935N1
Registration date:2014-07-15, 1393/04/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-07-15, 1393/04/24
Registrant information
Name
Zahra Bahrololoomi
Name of organization / entity
Shahid Sadoughi University of Medical Sciences-Yazd
Country
Iran (Islamic Republic of)
Phone
+98 35 1624 0691
Email address
zbahrololoom@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences of Yazd
Expected recruitment start date
2014-06-10, 1393/03/20
Expected recruitment end date
2014-08-11, 1393/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effect of chlorhexidine and combination of cholorhexidine-persica mouthwashes on chemotherapy-induced mucositis of children with hematologic malignancies
Public title
Evaluating the effect of simultaneous use of persica and chlorhexidine on chemotherapy-induced oral ulcers of children between 6 and 12 year old
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age range of 6-12 years; history of hematologic malignancies with the same treatment protocol; no history of sensitivity to any substances; no history of asthma, allergic rhinitis and dermatitis; no need of radiotherapy; written informed consent obtained from parents or legal guardian.
Exclusion criteria: occurrence of any infection; occurrence of sensitivity to mouth-rinses.
Age
From 6 years old to 12 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Sadoughi University of Medical Sciences
Street address
Central Organization for Shahid Sadoughi University of Medical Sciences, Bahonar Sq., Yazd
City
Yazd
Postal code
8916978477
Approval date
2014-05-03, 1393/02/13
Ethics committee reference number
17/1/31866/پ
Health conditions studied
1
Description of health condition studied
Chemotherapy-induced mucositis
ICD-10 code
K13.7
ICD-10 code description
Other and unspecified lesions of oral mucosa
Primary outcomes
1
Description
Incidence of mucositis
Timepoint
Day 1 (before intervention), 8 and 15
Method of measurement
World Health Organization (WHO) grading
2
Description
Severity of mucositis
Timepoint
Day 1 (before intervention), 8 and 15
Method of measurement
World Health Organization (WHO) grading; Oral Assessment Guide (OAG) grading
Secondary outcomes
1
Description
Severity of pain
Timepoint
Day 1 (before intervention), 8 and 15
Method of measurement
Facial Image Scale
Intervention groups
1
Description
Rinsing with normal saline (15 ml) followed by chlorhexidine 0.2% mouthwash (15 ml), 2 times a day (after breakfast and dinner) for 2 weeks
Category
Prevention
2
Description
Rinsing with persica oral drops (10 drops in 15 ml water) followed by chlorhexidine 0.2% mouthwash (15 ml), twice a day (after breakfast and dinner) for 2 weeks
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Private Clinic of Dr. Azam Sadat Hashemi
Full name of responsible person
Dr. Azam Sadat Hashemi
Street address
Atlasi Building, Atlasi Sq.
City
Yazd
2
Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital of Yazd
Full name of responsible person
Dr. Azam Sadat Hashemi
Street address
Ebne Sina Ave.
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Shahid Sadoughi University of Medical Sciences of Yazd
Full name of responsible person
Dr. Fateme Ezoddini Ardakani
Street address
Shahid Sadoghi University of Medical Sciences, Bahonar Sq., Yazd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Shahid Sadoughi University of Medical Sciences of Yazd
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Dental Faculty of Shahid Sadoughi University of Medical Sciences of Yazd
Full name of responsible person
Dr. Yasamin Khaksar
Position
Postgraduate student of pediatric dentistry
Other areas of specialty/work
Street address
Faculty of Dentistry, Dahe Fajr Blvd., Yazd
City
Yazd
Postal code
Phone
+98 35 1625 5881
Fax
Email
yasamin.khaksar@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr. Azam Sadat Hashemi
Position
Hematology Oncology and Genetics Research Center, Shahid Sadoughi University of Medical Sciences
Other areas of specialty/work
Street address
Department of Pediatrics, Hematology, Oncology and Genetics Research Center, Shahid Sadoughi University of Medical Sciences, Yazd
City
Yazd
Postal code
Phone
+98 35 1822 9104
Fax
Email
drazamhashemi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Dental Faculty of Shahid Sadoughi University of Medical Sciences-Yazd
Full name of responsible person
Dr. Yasamin Khaksar
Position
Postgraduate student of pediatric dentistry
Other areas of specialty/work
Street address
Faculty of Dentistry, Dahe fajr Blvd., Yazd
City
Postal code
Phone
+98 35 1625 5881
Fax
Email
yasamin.khaksar@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)