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The Comparison of Teriadent and Thyme spray in aphthous: a clinical trial

Protocol summary

Study aim
The Comparison of Teriadent and Thyme spray in aphthous: a clinical trial
Design
Clinical trials with a control group, randomized. Patients are randomly divided into two groups using SPSS software.
Settings and conduct
This study will be performed on all patients referred to the the School of Dentistry of Islamic Azad University in 2019, whose diagnosis of minor oral aphthous in their oral mucosa has been confirmed. Sampling will be done based on inclusion and exclusion criteria and for each treatment group, 23 samples and a total of 46 samples will be considered.
Participants/Inclusion and exclusion criteria
Inclusion criteria: definitive diagnosis of minor oral aphthous by specialist dentistry, life span is 2 days or less, consent to participate in the study. Exclusion criteria: Pregnancy, concomitant use of any topical drug for the treatment of aphthous, atypical cases of pests and cases suspected of Behcet's syndrome, inflammatory bowel disease, or history of any type of underlying illness that can predispose a person to aphthous, age under 12 years, patients with diseases that impair wound or systemic healing such as diabetes, kidney disease, anemia, liver disease, use of any effective medications for wound healing, such as corticosteroids, anticoagulants, immunosuppressive drugs, chemotherapy, the use of any type of topical or systemic analgesic, and drug and tobacco use
Intervention groups
Control group: In this group, the drug treatment will be with triamcinolone (Triadent oral paste belonging to Raha Pharmaceutical Company) will be applied to the wound 4 times a day for 15 minutes. Intervention group: Thyme spray (Zardband company, Iran) will be sprayed in the mouth 4 times a day after each meal and at bedtime.
Main outcome variables
Clinical parameters include pain intensity and the size of the lesion.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210110049986N1
Registration date: 2021-01-23, 1399/11/04
Registration timing: retrospective

Last update: 2021-01-23, 1399/11/04
Update count: 0
Registration date
2021-01-23, 1399/11/04
Registrant information
Name
Mehrdad Taghibakhsh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2645 0339
Email address
mehrdad.taghibakhsh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-12, 1398/10/22
Expected recruitment end date
2020-02-19, 1398/11/30
Actual recruitment start date
2020-01-12, 1398/10/22
Actual recruitment end date
2020-02-19, 1398/11/30
Trial completion date
2020-02-25, 1398/12/06
Scientific title
The Comparison of Teriadent and Thyme spray in aphthous: a clinical trial
Public title
The Comparison of Teriadent and Thyme spray in aphthous: a clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of minor oral aphthous by specialist dentistry Life span is 2 days or less Consent to participate in the study Age above 12 years
Exclusion criteria:
Pregnancy Concomitant use of any topical drug for the treatment of aphthous. Use of any systemic treatment over the past 3 months. Atypical cases of pests and cases suspected of Behcet's syndrome, Inflammatory bowel disease, or history of any type of underlying illness that can predispose a person to aphthous. Age under 12 years Patients with diseases that impair wound or systemic healing such as diabetes, kidney disease, anemia, liver disease. Use of any effective medications for wound healing, such as corticosteroids, anticoagulants, immunosuppressive drugs, chemotherapy. The use of any type of topical or systemic analgesic. Drug and tobacco use
Age
From 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 23
Actual sample size reached: 23
Randomization (investigator's opinion)
Randomized
Randomization description
نمونه ها به روش دردسترس و غیراحتمالی انتخاب می شوند و از بین آنها بیمارانی که شرایط ورود به مطالعه را داشته باشند انتخاب خواهند شد. سپس بیماران به روش تصادفی ساده (به هر نمونه کدی اختصاص می یابد) و با استفاده از نرم افزار آماری spss به دو گروه کنترل و مداخله تقسیم خواهند شد.
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 Islamic Azad University - Dental Branch Tehran - Iran
Street address
No 9, Zeinali Street, Niavaran Street
City
Tehran
Province
Tehran
Postal code
۱۹۷۸۹۱۷۵۵۴
Approval date
2020-01-11, 1398/10/21
Ethics committee reference number
IR.IAU.DENTAL.REC.1398.060

Health conditions studied

1

Description of health condition studied
Oral Aphthae
ICD-10 code
K12.0
ICD-10 code description
Recurrent Oral Aphthae

Primary outcomes

1

Description
Pain intensity
Timepoint
Before starting treatment and on days 2, 4 and 6 after starting treatment
Method of measurement
with Pain Visual Analogue scale

2

Description
The size of the lesion
Timepoint
Before starting treatment and on days 2, 4 and 6 after starting treatment
Method of measurement
By ruler based on millimeters

Secondary outcomes

empty

Intervention groups

1

Description
Control group: In this group, the drug treatment will be with triamcinolone (Triadent oral paste belonging to Raha Pharmaceutical Company) will be applied to the wound 4 times a day for 15 minutes.
Category
Treatment - Drugs

2

Description
Intervention group: Thyme spray (Zardband company, Iran) will be sprayed in the mouth 4 times a day after each meal and at bedtime
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Faculty of Dentistry, Islamic Azad University of Tehran
Full name of responsible person
Mehrdad Taghibakhsh
Street address
No 9, Zeinali Street, Niavaran Street
City
Tehran
Province
Tehran
Postal code
۱۹۷۸۹۱۷۵۵۴
Phone
+98 21 2645 0339
Email
Mehrdad.taghibakhsh@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Arash Azizi
Street address
No 9, Zeinali Street, Niavaran Street
City
Tehran
Province
Tehran
Postal code
۱۹۷۸۹۱۷۵۵۴
Phone
+98 21 2645 0339
Email
drarashazizi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Mehrdad Taghibakhsh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No9, P16, 6th Street, Zeinali Street, Niavaran Street
City
Tehran
Province
Tehran
Postal code
۱۹۷۸۹۱۷۵۵۴
Phone
+98 21 2645 0339
Email
Mehrdad.taghibakhsh@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mehrdad Taghibakhsh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No9, P16, 6th Street, Zeinali Street, Niavaran Street
City
Tehran
Province
Tehran
Postal code
۱۹۷۸۹۱۷۵۵۴
Phone
+98 21 2645 0339
Email
Mehrdad.taghibakhsh@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad Javad Nasehi
Position
Student
Latest degree
Master
Other areas of specialty/work
Dentistry
Street address
No 1, P 2, Aghayi Street, Niavaran Street
City
Tehran
Province
Tehran
Postal code
1936785651
Phone
+98 21 2645 0339
Email
Drmjnasehi@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
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