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Comparison of the 1% and 2% Pilocarpine mouthwash on xerostomic patients

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History
# Registration date Revision Id
2 2022-05-18, 1401/02/28 226726
1 2021-03-03, 1399/12/13 173589
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  • Protocol summary

    Camparision of the 1% and 2% Pilocarpin mouthwash on xerostomic pathient
    Comparison of the 1% and 2% Pilocarpine mouthwash on xerostomic patient
    48 pathients in 3 grops, every grop 16 patheint Duble bilind
    48 patients were divided in 3 groups, every group were16 patients Double- blind design was performed
    48 نفر در 3 گروه 16 نفره دو سو کور
    48 نفر در 3 گروه 16 نفره تقسیم بندی شدند مطالعه دو سو کورطراحی شد
    Dental university
    islamic azad university /Dental school
    دانشگاه دندانپزشکی
    دانشگاه علوم پزشکی/دانشکده دندانپزشکی
    xerostomic pathient
    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
    بیمار مبتلا به خشکی دهان
    بیمار ان مبتلا به خشکی دهان واردمطالعه شدند شرايط خروج از مطالعه: وجود حاملگي/شیردهی در حال حاضر، ابتلا به ضايعه دهان استفاده از دنچر، حساسيت تماسي و آلرژي به پیلوكارپین، ابتلا به بيماري‌های بافت همبندی/ بيماري سيستميك/ سابقه راديوتراپي سر و گردن، ابتلا به HIV، هپاتيت C و B، ابتلا به پر فشاری خون ‌بيماري قلبي، بيماري كليوي، پاركينسون، بيماري آسم و COPD و گلوكوما، مصرف داروهای (شيميايي/گياهي) مصرف الكل و ترکیبات تنباكو به جز سيگار بود
    G1: 1% Pilocarpin mouthwash G2: 2% Pilocarpin mouthwash G3: 0% Pilocarpin mouthwash
    G1: 1% Pilocarpin mouthwash G2: 2% Pilocarpin mouthwash G3: 0% Pilocarpin mouthwash/placebo
    گروه 1 : دهانشویه پیلوکارپین 1% گروه 2 : دهانشویه پیلوکارپین 2% گروه 3 : دهانشویه پیلوکارپین 0%
    گروه 1 : دهانشویه پیلوکارپین 1% گروه 2 : دهانشویه پیلوکارپین 2% گروه 3 : دهانشویه پیلوکارپین 0%/پلاسبو
    Reduce of xerostomia
    Reduce of xerostomia/decrease of dry mouth complications
    کاهش خشکی دهان
    کاهش خشکی دهان در مبتلایان/تسکین مشکلات خشکی دهان

  • General information

    65
    60
    empty
    48
    empty
    2021-04-21, 1400/02/01
    empty
    2021-10-22, 1400/07/30
    empty
    2021-11-06, 1400/08/15
    empty
    correcting the writing,adding some datas
    empty
    تصحیح نگارش و اضافه کردن برخی موارد
    Camparision of the 1% and 2% Pilocarpin mouthwash on xerostomic pathient
    Comparison of the 1% and 2% Pilocarpine mouthwash on xerostomic patients
    Camparision of the 1% and 2% Pilocarpin mouthwash on xerostomic pathient
    Comparison of the 1% and 2% Pilocarpine mouthwash on xerostomic patients
    using drug
    using chemical/herbal drugs
    pregnant/milking
    connective tissue disorders
    allergy to plocarpine
    مصرف دارو
    مصرف داروی گیاهی/شیمیایی
    بارداری/شیردهی
    بیماری های بافت همبند
    حساسیت به پیلوکارپین
    metod : simple
    method : simple randomization
    روش : ساده
    روش : ساده تصادفی
    Pathient and me
    Patient and researcher

  • Health conditions studied

    #1
    empty
    ICD-10-CM
    empty
    ICD-10-CM Diagnosis Code R85.9
    Xerostomia
    Xerostomia, oral medicineوdry mouth,saliva
    خشکی دهان
    خشکی دهان, بیماری های دهان,بزاق

  • Primary outcomes

    #1
    45 & 60 & 75 after intervention
    in minute 45 & 60 & 75 in first and 14 days after intervention
    دقایق 45 و 60 و 75 بعد از مداخله
    دقایق 45 و 60 و 75 بعد از مداخله در روزاول و 14 مطالعه
    Absorbent by cotton rules
    Absorbent method
    جذبی بوسیله رول پنبه
    روش جذبی بزاق/رول پنبه

  • Intervention groups

    #1
    Control group: Plasbo
    Control group: Placebo

  • Recruitment centers

    #1
    Name of recruitment center - English: Dental university
    Name of recruitment center - Persian: دانشگاه دندانپزشکی
    Full name of responsible person - English: Babak Motamed
    Full name of responsible person - Persian: بابک معتمد
    Street address - English: No.1, Golnar Ave.,Pasdaran st.
    Street address - Persian: خیابان پاسداران،کوی گلنار ، پلاک 1
    City - English: tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1945643174
    Phone: +98 21 2232 6172
    Fax:
    Email: motttamed@gmail.com
    Web page address:
    Name of recruitment center - English: islamic azad university/Dental school
    Name of recruitment center - Persian: دانشگاه علوم پزشکی/دانشکده دندانپزشکی
    Full name of responsible person - English: dr Babak Motamed
    Full name of responsible person - Persian: دکتر بابک معتمد
    Street address - English: No.1, Golnar Ave.,Pasdaran st.
    Street address - Persian: خیابان پاسداران،کوی گلنار ، پلاک 1
    City - English: tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1945643174
    Phone: +98 21 2232 6172
    Fax:
    Email: motttamed@gmail.com
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Arezoo Alaee
    Full name of responsible person - Persian: ارزو علایی
    Street address - English: No 1, Neyestan 9 Ave., Pasdaran St.
    Street address - Persian: خیابان پاسداران ، کوی نیستان 9 ، پلاک 1
    City - English: tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 12329879540
    Phone: +98 21 2251 5700
    Fax:
    Email: arezoo.alaee@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: dr Arezoo Alaee
    Full name of responsible person - Persian: دکتر ارزو علایی
    Street address - English: No 1, Neyestan 9 Ave., Pasdaran St.
    Street address - Persian: خیابان پاسداران ، کوی نیستان 9 ، پلاک 1
    City - English: tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 12329879540
    Phone: +98 21 2251 5700
    Fax:
    Email: arezoo.alaee@yahoo.com
    Web page address:
    empty
    -
    empty
    -
    empty
    -

  • Person responsible for general inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Babak Motamed
    Full name of responsible person - Persian: بابک معتمد
    Position - English: Resident
    Position - Persian: رزیدنت
    Latest degree: med_doctor
    Area of specialty/work: 43
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: No 1 , Golnar Ave., Pasdaran St.
    Street address - Persian: خ. پاسداران ، کوی گلنار ، پ .1
    City - English: tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1945643174
    Phone: +98 21 2232 6172
    Mobile: +98 912 322 6908
    Fax:
    Email: motttamed@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: dr Babak Motamed
    Full name of responsible person - Persian: دکتربابک معتمد
    Position - English: Resident of oral medicine
    Position - Persian: رزیدنت بیماریهای دهان
    Latest degree: med_doctor
    Area of specialty/work: 43
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: No 1 , Golnar Ave., Pasdaran St.
    Street address - Persian: خ. پاسداران ، کوی گلنار ، پ .1
    City - English: tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1945643174
    Phone: +98 21 2232 6172
    Mobile: +98 912 322 6908
    Fax:
    Email: motttamed@gmail.com
    Web page address:

  • Person responsible for updating data


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Babak Motamed
    Full name of responsible person - Persian: بابک معتمد
    Position - English: Resident
    Position - Persian: رزیدنت
    Latest degree: med_doctor
    Area of specialty/work: 43
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: No.1,golnar Ave.,Pasdaran St.
    Street address - Persian: خیابان پاسداران ، کوی گلنار ، پلاک 1
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1945643174
    Phone: +98 21 2232 6172
    Mobile: +98 912 322 6908
    Fax:
    Email: alaee.a@iautmu.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: arezoo alaee
    Full name of responsible person - Persian: آرزوعلایی
    Position - English: oral medicine specialist
    Position - Persian: متخصص بیماری های دهان
    Latest degree: specialist
    Area of specialty/work: 43
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: ,neyestan 9 Ave.,Pasdaran St.
    Street address - Persian: خیابان پاسداران ، نیستان 9 دانشکده دندانپزشکی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1945643174
    Phone: +98 21 22564571-3
    Mobile: +98 912 811 7455
    Fax:
    Email: alaee.a@iautmu.ac.ir
    Web page address:

  • Sharing plan

    I nedd consultion
    I need consultation

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
Name
babak motamed
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2232 6172
Email address
alaee.a@iautmu.ac.ir
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

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Islamic azad university Tehran mediacal branch
Street address
No 1 , Golnar Ave., Pasdaran St.
City
Tehran
Province
Tehran
Postal code
1945643174
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

Secondary outcomes

empty

Intervention groups

1

Description
Control group: Placebo
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
islamic azad university/Dental school
Full name of responsible person
dr Babak Motamed
Street address
No.1, Golnar Ave.,Pasdaran st.
City
tehran
Province
Tehran
Postal code
1945643174
Phone
+98 21 2232 6172
Email
motttamed@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
dr Arezoo Alaee
Street address
No 1, Neyestan 9 Ave., Pasdaran St.
City
tehran
Province
Tehran
Postal code
12329879540
Phone
+98 21 2251 5700
Email
arezoo.alaee@yahoo.com
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

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
dr Babak Motamed
Position
Resident of oral medicine
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No 1 , Golnar Ave., Pasdaran St.
City
tehran
Province
Tehran
Postal code
1945643174
Phone
+98 21 2232 6172
Email
motttamed@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Babak Motamed
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No 1 , Golnar Ave., Pasdaran St.
City
tehran
Province
Tehran
Postal code
1945643174
Phone
+98 21 2232 6172
Email
motttamed@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
arezoo alaee
Position
oral medicine specialist
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
,neyestan 9 Ave.,Pasdaran St.
City
Tehran
Province
Tehran
Postal code
1945643174
Phone
+98 21 22564571-3
Fax
Email
alaee.a@iautmu.ac.ir

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
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