This study aims to evaluate the effect of Punica granatum flower tablets on the size and pain of patients with recurrent aphthous stomatitis.
Design
The total sample size is 24 patients.12 participants in the evaluation group and 12 participants in the control group will be enrolled. Patients with recurrent aphthous stomatitis will be divided randomly (block randomization) into 2 experimental and control groups. In experimental and control groups patients will receive pomegranate flower tablets and oral paste Triadent 0.1% respectively, three times a day for 7days.
Settings and conduct
This study is not blinded. The patients who will be referred to Shiraz Dental School for their recurrent aphthous stomatitis will be enrolled.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The participants should have recurrent aphthous stomatitis, The participants should not use other routine medication for RAS during evaluation, less than 24 hours from lesion onset time, The participants should not used systemic or topical corticosteroid since 1 month ago.
Exclusion criteria: The patients with Behcet disease, Crohn's disease, Reiter's syndrome, or any other inflammatory disease, pregnant women.
Intervention groups
In this study, the effect of Punica granatum flower tablets on the size and pain of patients with recurrent aphthous stomatitis will be assessed.
In the control group, triadent oral paste will be prescribed for recurrent aphthous stomatitis treatment.
Main outcome variables
The amount of pain, the size of lesion, healing period
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120101008585N12
Registration date:2022-01-26, 1400/11/06
Registration timing:prospective
Last update:2022-01-26, 1400/11/06
Update count:0
Registration date
2022-01-26, 1400/11/06
Registrant information
Name
Fatemeh Lavaee
Name of organization / entity
Shiraz Dental School
Country
Iran (Islamic Republic of)
Phone
+98 71 1631 9309
Email address
lavaeef@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-21, 1401/02/31
Expected recruitment end date
2022-10-22, 1401/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Punica granatum flower tablet on pain and healing of minor recurrent aphthous stomatitis: a randomized clinical trial
Public title
The effect of Punica granatum flower tablet on recurrent aphthous stomatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having recurrent aphtus stomatis
The participants should not use other routine medication for RAS during the evaluation
Less than 24 hours from lesion onset time
The participants should not use systemic or topical corticosteroid since 1 month ago.
Exclusion criteria:
The participants with other diseases including Behcet disease, Crohn disease, Reiter's syndrome, or any other inflammatory disease
The participants who have used analgesic mouthwash or systemic analgesia since 3 days ago
pregnant women
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Each block with 4 allocations, consisting of 2 allocations for intervention and 2 for the control group were considered. Six possible sequences of treatment allocation in each block were listed and each one was written on a card. Each time a block had been selected and the sequence of treatments was registered until the treatment allocations become completed for all 24 patients (6 blocks).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Ghasrdasht
City
Shiraz
Province
Fars
Postal code
7195845379
Approval date
2020-07-26, 1399/05/05
Ethics committee reference number
IR.SUMS.DENTAL.REC.1399.136
Health conditions studied
1
Description of health condition studied
Recurrent aphthous stomatitis
ICD-10 code
K12.0
ICD-10 code description
Recurrent oral aphthae
Primary outcomes
1
Description
The amount of pain
Timepoint
Day1,2,3,4,5,6,7 before and after treatment
Method of measurement
Visual anloge scale
2
Description
The size of lesion
Timepoint
Day1،2،3،4،5،6،7
Method of measurement
Degreed tongue blade
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with recurrent aphthous stomatitis in the experimental group will receive pomegranate flower tablets 3 tablets daily for 7days.
Category
Treatment - Drugs
2
Description
Control group: In the control group oral paste Triadent0.1% (Raha pharma. Isfahan-Iran) will be prescribed three times a day for 7 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz Dental School
Full name of responsible person
Fatemeh Lavaee
Street address
Ghasrdasht
City
Shiraz
Province
Fars
Postal code
7195845379
Phone
+98 71 3626 3193
Email
lavaeef@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Rezaianzade
Street address
Ghasrdasht
City
Shiraz
Province
Fars
Postal code
7195845379
Phone
+98 71 3212 2438
Email
lavaeef@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Lavaee
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Ghasrdasht
City
Shiraz
Province
Fars
Postal code
7195845379
Phone
+98 71 3626 3193
Email
lavaeef@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Lavaee
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Ghardasht
City
Shiraz
Province
Fars
Postal code
7195845379
Phone
+98 71 3626 3193
Email
lavaeef@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Lavaee
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Ghasrdasht
City
Shiraz
Province
Fars
Postal code
7195845379
Phone
+98 71 3626 3193
Email
lavaeef@sums.ac.ir
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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Statistical analysis file
When the data will become available and for how long
The data will be given to the requester by email.
To whom data/document is available
The data will be given to the requester by email.
Under which criteria data/document could be used
The data will be given to the requester by email.
From where data/document is obtainable
The data will be given to the requester by email.
What processes are involved for a request to access data/document