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Evaluate the effectiveness of c-Phycocyanin mucoadhesive paste on recurrent aphthous stomatitis (RAS)

Protocol summary

Study aim
Evaluate the effectiveness of c-Phycocyanin mucoadhesive paste on recurrent aphthous stomatitis (RAS)
Design
This study is a double-blind randomized clinical trial. Using random allocation software 2, patients are distributed into two control and intervention groups (each group includes 20 people) using the randomized block method of 2.
Settings and conduct
In this study, 40 patients referred to the diagnosis department of Sari Dental Faculty, who were diagnosed with recurrent aphthous stomatitis, were divided into two control and intervention groups (each group included 20 people). The test group received the pure compound c-Phycocyanin and the control group received placebo. Patients are asked to use the paste three times a day (morning, noon and night) for 30 minutes and then not to wash their mouth or eat for half an hour. They should do this for seven days continuously. At the beginning of the study and after 3, 5, and 7 days, the diameter of the lesions and the surrounding inflammatory area are recorded with the help of a metal caliper. Patients are also taught to rate the pain intensity based on the VAS scale from zero to ten.
Participants/Inclusion and exclusion criteria
Patients must have diagnostic criteria for aphthous disease and have sufficient knowledge to understand the explanations provided for the treatment and be legally able to complete their consent form. Exclusion criteria include people taking antibiotics and immunosuppressive drugs and people who cannot continue to cooperate until the end of the study due to personal or social reasons.
Intervention groups
The intervention group received c-Phycocyanin mucosal adhesive and the control group received placebo.
Main outcome variables
Mucoadhesive c-Phycocyanin Erythematous aura Length of recovery period the pain Age sex

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240802062616N1
Registration date: 2024-09-19, 1403/06/29
Registration timing: registered_while_recruiting

Last update: 2024-09-19, 1403/06/29
Update count: 0
Registration date
2024-09-19, 1403/06/29
Registrant information
Name
fatemeh taheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3588 2744
Email address
fatemehtaherii7798@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-17, 1403/06/27
Expected recruitment end date
2024-11-17, 1403/08/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluate the effectiveness of c-Phycocyanin mucoadhesive paste on recurrent aphthous stomatitis (RAS)
Public title
Investigating the effect of c-Phycocyanin pure compound on mouth sores
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with minor recurrent stomatitis, patients with aphthous lesions on the lips and buccal mucosa, not suffering from systemic disease, not taking immunosuppressive drugs in the past month, not using dentures, not taking antibiotics.
Exclusion criteria:
Exclusion criteria include people taking immunosuppressive drugs in the past month, people with systemic disease, people with syndromes such as Behcet's syndrome, where aphthous ulcers are one of its manifestations, patients with aphthous lesions in areas other than the lips and buccal mucosa, People with recurrent herpetiform stomatitis, People with major recurrent stomatitis, Patients with poor hygiene level, Pregnant women, Antibiotic users, Patients with dentures, People who use other drugs to treat plague and in general people who due to personal reasons or Social workers cannot continue to cooperate until the completion of the study.
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are distributed into two control and intervention groups with the help of random allocation software 2 and with the randomized block method of 2. Blocks will be considered as quadruplets (two people will be placed in each group in each block).
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are distributed into two control and intervention groups using a randomized block method of 2 (each group includes 20 people). Code A of the intervention group received mucoadhesive containing phycocyanin and code B of the placebo control group received mucoadhesive without active ingredient. The conditions of the study are explained to the patients, but they do not know which medicine has the active ingredient.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Moalem Square, Building No. 2 of the University, Research Vice Chancellor
City
Sari
Province
Mazandaran
Postal code
4815733971
Approval date
2024-07-08, 1403/04/18
Ethics committee reference number
IR.MAZUMS.REC.1403.187

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 and recovery of recurrent aphthous lesions
Timepoint
Days 0 (start of study), 3, 5 and 7
Method of measurement
Determining the diameter of lesions using a metal caliper and measuring the intensity of pain using a visual analog scale (VAS).

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: They receive mucus glue three times a day (morning, noon and night).
Category
Treatment - Drugs

2

Description
Control group: receives a placebo.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Tuba Dental Clinic
Full name of responsible person
Dr. Anahita Ghorbani
Street address
Khazar Boulevard, Tuba Dental Clinic
City
Sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 11 3325 4135
Email
aghorbani@mazums.ac.ir
Web page address
https://www.mazums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Pedram Ebrahimnejad
Street address
Moalem Square, Research and Technology Deputy Building
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3325 7230
Email
pajhooheshi@mazums.ac.ir
Web page address
https://www.mazums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Anahita Ghorbani
Position
Specialized doctorate in oral and dental diseases
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Khazar Boulevard, Tuba Dental Clinic
City
Sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 11 3324 4894
Email
aghorbani@mazums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Anahita Ghorbani
Position
Specialist in oral and dental diseases
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tuba Clinic, Khazar Street, Sari
City
Sari
Province
Mazandaran
Postal code
33971-48157
Phone
+98 911 151 3085
Email
‏anahita1802@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Fatemeh Taheri
Position
Dental student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Khazar Boulevard, Tubi Dental Clinic
City
Sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 905 572 3506
Email
fatemehtaherii7798@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
After the completion of the results plan, it will be delivered in the form of a final report and electronically (on a CD) to the Research Vice-Chancellor and Faculty of Dentistry of Mazandaran University of Medical Sciences.
When the data will become available and for how long
The decision regarding the access to the data will be the responsibility of the vice president of research and the Faculty of Dentistry of Mazandaran Faculty of Medical Sciences, as well as the supervisor.
To whom data/document is available
Vice President of Research, Faculty of Dentistry, Mazandaran University of Medical Sciences and also a supervisor
Under which criteria data/document could be used
To present the final report and write the article
From where data/document is obtainable
Vice President of Research, Faculty of Dentistry, Mazandaran University of Medical Sciences and also a supervisor
What processes are involved for a request to access data/document
A written request to the vice president of research or the Faculty of Dentistry of Mazandaran University of Medical Sciences, as well as the supervisor
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