The aim of this study is to evaluate the effect pilocarpine mouthwash on amount saliva in students of ahwaz jundishapur university. In this clinical trial and double- blind study 86 healthy students are included. Participants with any systemic disease or drug intake are excluded.Students are asked to avoid eating, drinking and brushing their teeth for 90 minutes before taking the mouthwash. Participants are randomly divided into two groups:
Group A (Cases) [Students who get the pilocarpine]
Group B (Control) [Students who get saline instead of the pilocarpine]
Each students will use the mouthwash (Pilocarpine or saline) only once. Their saliva will be collected before, immediately and one hour after mouthwash rinse.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014102719698N1
Registration date:2015-02-07, 1393/11/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-02-07, 1393/11/18
Registrant information
Name
Fatemeh Babadi
Name of organization / entity
Ahwaz jundi Shapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3320 5319
Email address
babadi-f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahwaz Jundi Shapur University Of Medical Scieces
Expected recruitment start date
2014-12-11, 1393/09/20
Expected recruitment end date
2015-06-10, 1394/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect pilocarpine mouthwash and saline on the amount saliva in students in ahwaz jundi shspur university of medical scieces
Public title
The Effect of pilocarpine mouthwash on measure saliva
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : healthy students
exclusion criteria : cardiovascular disease , asthma , radiotherapy , drugs user and any systemic conditions effect on a mouth saliva
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
86
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahwaz Jundi Shapur University Of Medical Sciences
Street address
Univercity Of Medical Sciences , Golestan , Ahwaz
City
Ahwaz
Postal code
Approval date
2014-10-04, 1393/07/12
Ethics committee reference number
ajums.REC.1393.237
Health conditions studied
1
Description of health condition studied
Amount Saliva
ICD-10 code
R85
ICD-10 code description
Abnormal findings in specimens from digestive organs and abdominal cavity
Primary outcomes
1
Description
measure saliva
Timepoint
before intervention ,immediately after intervention , 1 h after intervention
Method of measurement
ML
Secondary outcomes
1
Description
measure moisture mouth
Timepoint
1h after intervention
Method of measurement
on the basies questionnaire
2
Description
speaking condition
Timepoint
1h after intervention
Method of measurement
on the basies questionnaire
3
Description
ingestion condition
Timepoint
1h after intervention
Method of measurement
on the basies questionnaire
4
Description
feeling saltiness taste
Timepoint
1h after intervention
Method of measurement
on the basies questionnaire
Intervention groups
1
Description
Intervention Group :2% Concentrtion , Once , Pilocarpine Mouthwash
Category
Placebo
2
Description
Control Group :2% Concentrtion , Once , Placebo ( Saline) , Mouthwash Once
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahwaz Jundi Shapur University Of Medical Sciences School Of Dental Medicine
Full name of responsible person
Dr Fatemeh Babadi
Street address
Ahwaz Jundi Shapur University Of Medical Sciences
City
Ahwaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahwaz Jundi Shapur University Of Medical Sciences
Full name of responsible person
Dr Fatemeh Babadi
Street address
Ahwaz Jundi Shapur University Of Medical Sciences School Of Dental Medicine
City
Ahwaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahwaz Jundi Shapur University Of Medical Sciences
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
Ahwaz Jundi Shapur University Of Medical Sciences
Full name of responsible person
Dr Fatemeh Babadi
Position
Asistant Professor Of Oral And Maxillofatioal Medicen
Other areas of specialty/work
Street address
Ahwaz Jundi Shapur University Of Medical Sciences
City
Ahwaz
Postal code
Phone
+98 61 3443 4574
Fax
Email
babadi-f@ajums.ac.ir , babadi.fatemeh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahwaz Jundi Shapur University Of Medical Sciences
Full name of responsible person
Dr Fatemeh Babadi
Position
Specialist Oral And Maxillofatioal Disease
Other areas of specialty/work
Street address
Ahwaz Jundi Shapur University Of Medical Sciences
City
Ahwaz
Postal code
Phone
+98 61 3443 4574
Fax
Email
babadi-f@ajums.ac.ir , babadi.fatemeh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahwaz Jundi Shapur University Of Medical Sciences
Full name of responsible person
Dr Fatemeh Babadi
Position
Asistant Professor Of Oral And Maxillofatioal Medicen
Other areas of specialty/work
Street address
Ahwaz Jundi Shapur University Of Medical Sciences School Of Dental Medicine
City
Ahwaz
Postal code
Phone
+98 61 3443 4574
Fax
Email
babadi-f@ajums.ac.ir , babadi.fatemeh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)