The purpose of this study is comparison of chewing gum and salivary glands massage in treatment of xerostomia. This study is a randomized clinical trial without placebo. The inclusion criteria is having xerostomia and the exclusion criteria is having mouth drying habits.This study will be done on 60 patients with xerostomia who are referred to Yazd Dentistry School. Intervention for this study, evaluates effect of two different methods including chewing six pieces of sugar free gum with mint flavor per day and salivary glands massage ten times in a day and each time ten times for a period of 3 months. Primary outcome measure includes unstimulated and stimulated whole salivary flow rate which is measured by ml/min.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201211149103N2
Registration date:2012-12-31, 1391/10/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-12-31, 1391/10/11
Registrant information
Name
Neda Gholami
Name of organization / entity
Yazd Shahid Sadoughi University of Medical Science, Dental school
Country
Iran (Islamic Republic of)
Phone
+98 35 1622 0022
Email address
drahadian@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences and Health Services
Expected recruitment start date
2011-10-23, 1390/08/01
Expected recruitment end date
2012-04-18, 1391/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of therapeutic effect of chewing gum and salivary glands massage, in treatment of xerostomia
Public title
effect of salivary glands massage in treatment of xerostomia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with xerostomia
Exclusion criteria :
Drying habits such as mouth breathing
Age
From 18 years old to 149 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Yazd Shahid Sadoughi University of Medical Sciences
Street address
Central part of the Shahid Sadoughi University of Medical Sciences, Shahid Bahounar Square, Yazd, Iran
City
Yazd
Postal code
8916978477
Approval date
2012-02-27, 1390/12/08
Ethics committee reference number
17/1/153924/پ
Health conditions studied
1
Description of health condition studied
xerostomia
ICD-10 code
k11.7
ICD-10 code description
disturbances of salivary secretion
Primary outcomes
1
Description
unstimulated whole saliva flow rate
Timepoint
before intervention, 3 mounth after starting intervention
Method of measurement
Ml per minute
2
Description
stimulated whole saliva flow rate
Timepoint
before intervention, 3 mounth after starting intervention
Method of measurement
Ml per minute
Secondary outcomes
empty
Intervention groups
1
Description
Sugar free gum with mint flavor/Six pieces per day/3 months
Category
Treatment - Other
2
Description
Salivary glands massage/ ten times per hour, ten hours a day/3 months
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Shadid Sadoughi University of Medical Sciences, Dental School
Full name of responsible person
Narges Mirjalili
Street address
Shahid Sadoughi University of Medical Sciences, Dental School, Fazaye sabz Crossroad, Dahe-fajr Blv, Yazd, Iran
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd Shahid Sadoughi University of Medical Sciences, Dental School
Full name of responsible person
Fatemeh Ezodini
Street address
Yazd Shahid Sadoughi University of Medical Sciences, Dental School, Fazaye sabz Crossroad, Dahe-fajr Blv, Yazd, Iran
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd Shahid Sadoughi University of Medical Sciences, Dental School
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
Yazd Shahid Sadoughi University of Medical Sciences, Dental School
Full name of responsible person
Mehdi Gazerani
Position
under graduate stundent
Other areas of specialty/work
Street address
Yazd Shahid Sadoughi University of Medical Sciences, Dental School, Fazaye sabz Crossroad, Dahe-fajr Blv, Yazd, Iran
City
Yazd
Postal code
Phone
+98 35 1621 2222
Fax
Email
dent.mehdi@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
Narges Mirjalili
Position
Specialist in Oral and Maxillofacial Medicine
Other areas of specialty/work
Street address
Yazd Shahid Sadoughi University of Medical Sciences, Dental School, Fazaye sabz Crossroad, Dahe-fajr Blv, Yazd, Iran
City
Yazd
Postal code
Phone
+98 35 1621 2222
Fax
Email
n_mirjalili@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yazd Shahid Sadoughi University of Medical Sciences, Dental School
Full name of responsible person
Mehdi Gazerani
Position
Under graduate student
Other areas of specialty/work
Street address
Yazd Shahid Sadoughi University of Medical Sciences, Dental School, Fazaye sabz Crossroad, Dahe-fajr Blv, Yazd, Iran
City
Yazd
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)