Protocol summary

Study aim
Identifying the effects of aloe vera and cinnamon on stimulating and moisturizing the oral mucosa
Design
80 people who participated in the study were divided into 4 groups, the 4th group is considered as the control group
Settings and conduct
double-blind clinical trial study in the Faculty of Dentistry of Kerman , which is conducted on people with dry mouth in 4 groups: aloe vera extract, cinnamon extract, 50% solution of aloe vera extract and cinnamon, and negative control. XI questionnaire, visual scale (VAS), OHIP-14 questionnaire are used to evaluate dry mouth. In order to check the amount of saliva secretion before and after the intervention, a spitting test is performed. Both participants and investigators will be blinded to treatment assignment. Block randomization is used to control the effect of confounders. In this way, first, a sequence of random numbers of four is generated, and then, after registering the person, the researcher contacts the statistics expert based in the research center, and the person's group is determined, and the desired spray is given to the person.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients between 18 years old and older with dry mouth Exclusion criteria: pregnancy, allergy to cinnamon or aloe vera, history of radiotherapy and chemotherapy, uncontrolled chronic disease and HIV, hepatitis C or hepatitis B infection.
Intervention groups
Intervention group 1 includes patients with dry mouth, who receive the intervention of aloe vera extract. Intervention group 2 includes patients with dry mouth, who receive cinnamon extract intervention. Intervention group 3 includes patients with dry mouth, who receive the intervention of the combination of cinnamon extract and aloe vera. The control group includes patients with dry mouth, who receive normal saline intervention
Main outcome variables
dry mouth

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240804062631N2
Registration date: 2024-10-08, 1403/07/17
Registration timing: retrospective

Last update: 2024-10-08, 1403/07/17
Update count: 0
Registration date
2024-10-08, 1403/07/17
Registrant information
Name
Sina Kakooei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3211 3736
Email address
kakooei.s@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-07, 1403/06/17
Expected recruitment end date
2024-10-08, 1403/07/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of aloe vera and cinnamon on stimulation and moisture absorption in oral mucosa: A double-blind clinical trial
Public title
evaluation of the effect of aloe vera and cinnamon on moisture absorption in oral mucosa
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients 18 years and older Visiting the Faculty of Dentistry
Exclusion criteria:
Pregnancy Allergy to cinnamon or aloe vera History of radiotherapy and chemotherapy Uncontrolled chronic disease HIV, hepatitis C or hepatitis B infection
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method and description of each method: block randomization Randomization Unit: Individual For randomization, one letter from A, B, C, D is assigned to each group. Then 76 envelopes containing one of the 4 letters A, B, C, D are prepared in the number of 19 for each group and are placed inside a box. When each person enters the study, an envelope is randomly selected and opened. and the person is assigned to that group. The study groups will remain confidential until after the analysis of the study results
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to blind the researcher and volunteers to participate in the study, the sprays are numbered with numbers one to four. Barij essence is added to all groups to equalize the smell and taste
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Jahad Ave
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2024-08-13, 1403/05/23
Ethics committee reference number
IR.KMU.REC.1403.253

Health conditions studied

1

Description of health condition studied
XEROSTOMIA
ICD-10 code
R68.2
ICD-10 code description
Dry mouth, unspecified

Primary outcomes

1

Description
Determining the effect of aloe vera and cinnamon on stimulating and moisturizing the oral mucosa
Timepoint
Oral saliva measurement at the beginning of the study (before the start of the intervention) and 14 days after the start of cinnamon and aloe vera spray.
Method of measurement
Spitting test

Secondary outcomes

empty

Intervention groups

1

Description
The first intervention group: aloe vera extract spray, Three times a day, 3 puffs of spray each time for two weeks, This spray is prepared by a doctor of pharmacy who is the pharmaceutical consultant of the present project at the research center for oral and dental diseases
Category
Treatment - Drugs

2

Description
The second intervention group: cinnamon extract spray, Three times a day, 3 puffs of spray each time for two weeks,This spray is prepared by a doctor of pharmacy who is the pharmaceutical consultant of the present project at the research center for oral and dental diseases
Category
Treatment - Drugs

3

Description
The third intervention group: Spray an equal solution of cinnamon and aloe vera, three times a day, Three times a day, 3 puffs of spray each time for two weeks, This spray is prepared by a doctor of pharmacy who is the pharmaceutical consultant of the present project at the research center for oral and dental diseases
Category
Treatment - Drugs

4

Description
Control group: Normal saline spray, Three times a day, 3 puffs of spray each time for two weeks, This spray is prepared by a doctor of pharmacy who is the pharmaceutical consultant of the present project at the research center for oral and dental diseases
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Oral and Dental Diseases Research Center
Full name of responsible person
Shahla Kakoei
Street address
Kousar Blvd
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3212 6024
Email
skakoei@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr.Abedin Iranpour
Street address
Jahad Ave
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3857
Email
int_dep@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Sina Kakooei
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Dentistry
Street address
Kosar Blvd-Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3211 3736
Fax
Email
kakooei.s@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Shahla Kakoei
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Kosar Blvd-Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3211 3736
Fax
Email
skakoei@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Shahla Kakoei
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Kosar Blvd
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3211 3736
Fax
Email
skakoei@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Participant data file, part of the data such as information related to the main outcome.
When the data will become available and for how long
The access period starts 6 months after the publication of the article
To whom data/document is available
Public access after publication of the article
Under which criteria data/document could be used
Using the data published in the article citing the article
From where data/document is obtainable
Correspondence with the corresponding author Shahla Kakoei 09131408974 skakoei@gmail.com
What processes are involved for a request to access data/document
The applicant can correspond with the responsible author through email.
Comments
Loading...