One of the most important side effects of frequent haemodialysis is xerostomia. So this study tries to compare saliva secretion caused by a specific saliva stimulus chewing gum (Bioten) with an ordinary sugar free one (Orbit) on haemodialysis patients. This study is a clinical, double-blind and cross-over study. In which 30 volunteer haemodialysis patients of two dialysis canters in Isfahan will be randomly classified into two groups. In the first period for 14 days, each group will be given one brand of chewing gum (Bioten or Orbit), to chew 3 gums a day, each time for at least 10 minutes, while the other group will be given the other brand. After a one- week-washout period in between, the second 14 days period will accomplish by changing the brands of chewing gums given to each group. To double blind the study, the gum boxes will be simulated and coded by another person. Before the beginning of the study and after each period, the secreted saliva will be measured. The findings will be statistically analyzed using Pair T, ANOVA and Mann Whitney tests.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903244174N1
Registration date:2010-09-30, 1389/07/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-09-30, 1389/07/08
Registrant information
Name
Maryam Karami
Name of organization / entity
Islamic Azad University-Khorasgan Branch
Country
Iran (Islamic Republic of)
Phone
+98 31 1778 0149
Email address
mkarami@dental.khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2008-04-20, 1387/02/01
Expected recruitment end date
2008-06-21, 1387/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison between the effects of two saliva stimulus and ordinary chewing gums on xerostomia in haemodialysis patients.
Public title
The effect of chewing gum on xerostomia in haemodialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 1-haemodialysis patients 2-informrd consent and willing to cooperate 3-not to chew any other gums during the study
Exclusion criteria: unwilling to continue
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Islamic Azad University Khorasgan Branch
Street address
Arghavanieh
City
Esfahan
Postal code
Approval date
2008-01-03, 1386/10/13
Ethics committee reference number
23810201862005
Health conditions studied
1
Description of health condition studied
xerostomia in haemodialysis patients
ICD-10 code
K11.7
ICD-10 code description
Disturbances of salivary secretion; Xerostomia
Primary outcomes
1
Description
stimulated salivary secretion
Timepoint
14 days
Method of measurement
secreted saliva(measuring the weight of secreted saliva
Secondary outcomes
empty
Intervention groups
1
Description
chewing Orbit gums in the first period and Biotene gums in the second period
Category
Prevention
2
Description
chewing Biotene gums in the first period and Orbit gums in the second period
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra and Khorshid dialysis centers
Full name of responsible person
Dr Maryam Karami
Street address
Islamic Azad University Khorasgan Branch
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Investigator
Full name of responsible person
Dr Shakiba Hoseinzade
Street address
Arghavanieh
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Investigator
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
Islamic Azad University Khorasgan Branch
Full name of responsible person
Maryam Karami
Position
Assistant professor
Other areas of specialty/work
Street address
Arghavanieh
City
Isfahan
Postal code
Phone
+98 913 114 6910
Fax
Email
maryam_karami@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University Khorasgan Branch
Full name of responsible person
Maryam Karami
Position
Assistant Professor
Other areas of specialty/work
Street address
Arghavanieh
City
Isfahan
Postal code
Phone
+98 913 114 6910
Fax
Email
maryam_karami@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University Khorasgan Branch
Full name of responsible person
Maryam Karami
Position
Assistant professor
Other areas of specialty/work
Street address
Arghavanieh
City
Esfahan
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)