The aim of this study was to compare between the effect of lemon extract and aloe vera and placebo on moisturizing the oral cavity in patients with dry mouth.
Design
Phase 2 crossover clinical trial on 30 patients
Settings and conduct
Initially, each patient who came to the dental school with complaints of dry mouth, expressed the degree of dry feeling in his/her mouth based on the VAS index. In this index, the number 10 indicates severe dryness and the number 0 indicates no dry mouth. The VAS number recorded on first day (visit day), third day and fifth day. After that at least one week without medication considered as days off. Then the second and third medicines measured in the same way, respectively.
Directions:
3 times a day, 5ml each time, for 40 seconds, swirl in the mouth as a mouthwash and then discard.
Participants/Inclusion and exclusion criteria
Entry conditions:
Age between 18 to 50 years - Dry mouth feeling
No entry conditions:
Taking anti-cancer medicine - History of radiotherapy / chemotherapy - Pregnancy and breastfeeding - History of allergy
Intervention groups
Group 1: Aloe vera extract
Group 2: Lemon extract
Group 3: placebo
Main outcome variables
Dry mouth feeling
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200927048847N2
Registration date:2020-12-16, 1399/09/26
Registration timing:retrospective
Last update:2020-12-16, 1399/09/26
Update count:0
Registration date
2020-12-16, 1399/09/26
Registrant information
Name
Leila Rajaei Behbahani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3338 3230
Email address
rajaeebehbahani-l@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-03-10, 1398/12/20
Actual recruitment start date
2019-09-29, 1398/07/07
Actual recruitment end date
2020-10-18, 1399/07/27
Trial completion date
2020-11-18, 1399/08/28
Scientific title
Comparison between the effect of lemon extract and aloe vera on moisturizing oral cavity in patients with dry mouth in ahvaz dental school
Public title
Comparison between the effect of lemon extract and aloe vera on moisturizing oral cavity in patients with dry mouth
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Dry mouth feeling
Age between 18 to 50 years
Exclusion criteria:
Taking anti-cancer medicine
History of radiotherapy / chemotherapy
Pregnancy and breastfeeding
History of allergy
Age
From 18 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
3
3 medicines separately at regular intervals
Actual sample size reached:
30
More than 1 sample in each individual
Actual sample size in each individual:
3
3 medicines separately at regular intervals
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Containers containing 3 medicines (A, B, C) and 3 questionnaires were placed in a opaque envelope by a reliable person who is outside of the study and delivered to the patient. The results can be analyzed only at the end of the research by a statistical consultant.
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Jundishapour University of Medical Sciences
Street address
Ahvaz Jundishapour University of Medical Sciences, Esfand St., Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715775
Approval date
2019-07-14, 1398/04/23
Ethics committee reference number
IR.AJUMS.REC.1398.288
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
Dry mouth feeling based on VAS index
Timepoint
Firs, third and fifth day for each medicine
Method of measurement
VAS index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Patients who receive Aloe Vera extract from Barij Essence company - Directions: 3 times a day, 5ml each time, for 40 seconds, swirl in the mouth as a mouthwash and then discard.
Category
Treatment - Drugs
2
Description
Intervention group 2: Patients who receive Lemon extract from one and one company - Directions: 3 times a day, 5ml each time, for 40 seconds, swirl in the mouth as a mouthwash and then discard.
Category
Treatment - Drugs
3
Description
Control group 3: Patients who receive Hygienic pure water from Shahid Ghazi Pharmaceutical Company - Directions: 3 times a day, 5ml each time, for 40 seconds, swirl in the mouth as a mouthwash and then discard.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz dental school
Full name of responsible person
Sara Rajaei Behbahani
Street address
Ahvaz Jundishapour University of Medical Sciences, Esfand St., Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715775
Phone
+98 61 3320 5168
Email
Sara.rajaeii@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehdi Ahmadi Moghadam
Street address
Ahvaz Jundishapour University of Medical Sciences, Esfand St., Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715775
Phone
+98 61 3336 2414
Fax
+98 61 3336 1544
Email
research@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Sara Rajaei Behbahani
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Ahvaz Jundishapour University of Medical Sciences, Esfand St., Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715775
Phone
+98 61 3320 5168
Email
Sara.rajaeii@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Leila Rajaei Behbahani
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Ahvaz Jundishapour University of Medical Sciences, Esfand St., Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715775
Phone
+98 61 3320 5168
Email
rajaeebehbahani-l@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Sara Rajaei Behbahani
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Ahvaz Jundishapour University of Medical Sciences, Esfand St., Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715775
Phone
+98 61 3320 5168
Email
Sara.rajaeii@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available