Protocol summary
-
Study aim
-
Comparison of the 1% and 2% Pilocarpine mouthwash on xerostomic patient
-
Design
-
48 patients were divided in 3 groups, every group were16 patients
Double- blind design was performed
-
Settings and conduct
-
islamic azad university /Dental school
-
Participants/Inclusion and exclusion criteria
-
xerostomic patient was included in research
exclusions criteria were:
milking/pregnancy,mucosal disease,connectine tissue disorders,Hepatitis B/C,HIV,Allergy to pilocarpine,hypertension,Herbal drugs,systemic disorders,alcoholism,denture wearing
-
Intervention groups
-
G1: 1% Pilocarpin mouthwash
G2: 2% Pilocarpin mouthwash
G3: 0% Pilocarpin mouthwash/placebo
-
Main outcome variables
-
Reduce of xerostomia/decrease of dry mouth complications
General information
-
Reason for update
-
correcting the writing,adding some datas
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20210208050302N1
Registration date:
2021-03-03, 1399/12/13
Registration timing:
prospective
Last update:
2022-05-18, 1401/02/28
Update count:
1
-
Registration date
-
2021-03-03, 1399/12/13
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2021-04-09, 1400/01/20
-
Expected recruitment end date
-
2021-08-23, 1400/06/01
-
Actual recruitment start date
-
2021-04-21, 1400/02/01
-
Actual recruitment end date
-
2021-10-22, 1400/07/30
-
Trial completion date
-
2021-11-06, 1400/08/15
-
Scientific title
-
Comparison of the 1% and 2% Pilocarpine mouthwash on xerostomic patients
-
Public title
-
Comparison of the 1% and 2% Pilocarpine mouthwash on xerostomic patients
-
Purpose
-
Treatment
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
xerostomia
Exclusion criteria:
using chemical/herbal drugs
pregnant/milking
connective tissue disorders
allergy to plocarpine
-
Age
-
From 18 years old to 60 years old
-
Gender
-
Both
-
Phase
-
1-2
-
Groups that have been masked
-
- Participant
- Care provider
-
Sample size
-
Target sample size:
48
Actual sample size reached:
48
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
method : simple randomization
-
Blinding (investigator's opinion)
-
Double blinded
-
Blinding description
-
Patient and researcher
-
Placebo
-
Used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2021-02-15, 1399/11/27
-
Ethics committee reference number
-
IR.IAU.DENTAL.REC.1399.282
Health conditions studied
1
-
Description of health condition studied
-
Xerostomia, oral medicineوdry mouth,saliva
-
ICD-10 code
-
ICD-10-CM
-
ICD-10 code description
-
ICD-10-CM Diagnosis Code R85.9
Primary outcomes
1
-
Description
-
Saliva rate
-
Timepoint
-
in minute 45 & 60 & 75 in first and 14 days after intervention
-
Method of measurement
-
Absorbent method
Intervention groups
1
-
Description
-
Control group: Placebo
-
Category
-
Treatment - Drugs
1
-
Sponsor
-
-
Grant name
-
-
-
Grant code / Reference number
-
-
-
Is the source of funding the same sponsor organization/entity?
-
No
-
Title of funding source
-
Babak Motamed
-
Proportion provided by this source
-
100
-
Public or private sector
-
Private
-
Domestic or foreign origin
-
Domestic
-
Category of foreign source of funding
-
empty
-
Country of origin
-
-
Type of organization providing the funding
-
Persons
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
No - There is not a plan to make this available
-
Justification/reason for indecision/not sharing IPD
-
I need consultation
-
Study Protocol
-
Undecided - It is not yet known if there will be a plan to make this available
-
Statistical Analysis Plan
-
Undecided - It is not yet known if there will be a plan to make this available
-
Informed Consent Form
-
Undecided - It is not yet known if there will be a plan to make this available
-
Clinical Study Report
-
Undecided - It is not yet known if there will be a plan to make this available
-
Analytic Code
-
Not applicable
-
Data Dictionary
-
Not applicable