Comparison of the palliative effects and stability of Diphenhydramine-Almgs versus 0.1% Teriadent oral paste in patients with Recurrent Aphthous Stomatitis
Assessment of physical stability and function of the combined solution in reducing pain and burning and its acceptance by clients
Design
Clinical trial study, with parallel groups
Settings and conduct
This study was performed on 50 patients referring to Apadana Dental Clinic with multiple oral aphthous lesions divided into two groups of 25 each. The first group received diphenhydramine-Almgs solution and the second group received 0.1% triadent oral paste. Then the physical stability of the combined solution will be assessed and the two groups will be compared regarding the duration of the wound healing, the rate of pain and burning (VAS criterion) and ultimately the patients' satisfaction.
Participants/Inclusion and exclusion criteria
Entry requirements:
Multiple aphthous ulcers (more than 1) that appeared in the mouth less than 48 hours.
People over 18 years;
Exit conditions:
A well-known history of increased drug sensitivity
Systemic diseases such as Behcet, Crohn's disease, thalassemia
Vitamin B12 deficiency and iron deficiency
Pregnant and lactating women
smokers
Taking oral antihistamine or non-steroidal anti-inflammatory drugs over the past week
Aphthous ulcers adjacent to trauma caused by sharp teeth, fractured healing, orthodontic appliance or partial prosthesis
Intervention groups
Intervention group: Diphenhydramine-Almgs solution was washed 3 times daily, 10cm for one minute, then mouthwashed and avoided eating for half an hour thereafter.
Control group: Teriadent oral paste rubbed on the lesion 3 times daily, and avoid eating and drinking for up to half an hour.
Main outcome variables
1. Comparison of the analgesic effect and the VAS score of pain and burning in the two groups receiving the combination solution and oral paste
2. Determine patients' satisfaction with the combination of oral solution and paste
3. Comparison of the recovery time of RAS in the two groups
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150706023084N4
Registration date:2020-01-19, 1398/10/29
Registration timing:retrospective
Last update:2020-01-19, 1398/10/29
Update count:0
Registration date
2020-01-19, 1398/10/29
Registrant information
Name
MARYAM SHIEHMORTEZA
Name of organization / entity
AZAD UNIVERSITY PHARMACEUTICAL SCIENCES
Country
Iran (Islamic Republic of)
Phone
+98 212640056
Email address
shiehmorteza@iaups.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-10-22, 1398/07/30
Actual recruitment start date
2018-12-22, 1397/10/01
Actual recruitment end date
2019-10-07, 1398/07/15
Trial completion date
2019-10-07, 1398/07/15
Scientific title
Comparison of the palliative effects and stability of Diphenhydramine-Almgs versus 0.1% Teriadent oral paste in patients with Recurrent Aphthous Stomatitis
Public title
Comparison of the palliative effect of Diphenhydramine-Almgs versus 0.1% Teriadent oral paste in patients with Recurrent Aphthous Stomatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Multiple aphthous ulcers (more than 1) that appeared in the mouth less than 48 hours.
People over 18 years
Exclusion criteria:
A well-known history of increased drug sensitivity
Systemic diseases such as Behcet, Crohn's disease, thalassemia
Vitamin B12 deficiency and iron deficiency
Pregnant and lactating women
smokers
Taking oral antihistamine or non-steroidal anti-inflammatory drugs over the past week
Aphthous ulcers adjacent to trauma caused by sharp teeth, fractured healing, orthodontic appliance or partial prosthesis
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Actual sample size reached:
50
Randomization (investigator's opinion)
Not randomized
Randomization description
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 of Tehran
Street address
no. 165, Golsar Blvd.
City
Rasht
Province
Guilan
Postal code
4166733658
Approval date
2018-06-13, 1397/03/23
Ethics committee reference number
IR.IAU.PS.REC.1397.323
Health conditions studied
1
Description of health condition studied
Recurrent Aphthous Stomatitis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Recurrent pest as one of the most common oral mucosal diseases is a recurrent and painful disease that, due to the unclear etiology and lack of definitive treatment, requires repeated periods of treatment and use of drugs with minimal local or systemic complications. has it.
Timepoint
At the beginning of the study, the third and seventh days
Method of measurement
Questionnaire and pH meter to evaluate the pH changes of the combined solution
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This group received 10 ml of the solution of mouthwash 3 times daily for one minute, then mouthwashed and avoided eating for half an hour thereafter. On the third and seventh days, patients' statements about time to relieve pain and complete wound healing were recorded by a questionnaire.
Category
Treatment - Drugs
2
Description
Control group: The group rubbed the oral paste as a thin layer with a clean finger or applicator three times daily, avoiding eating and drinking for half an hour. On the third and seventh days, patients' statements about time to relieve pain and complete wound healing were recorded by a questionnaire.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Apadana dental clinic
Full name of responsible person
Mahtab ghamgosar
Street address
Golsar Blvd.
City
Rasht
Province
Guilan
Postal code
4166786783
Phone
+98 13 3312 6440
Email
info@labkhand.info
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farshad Hashemian
Street address
Shariati St., Khaghani St., Tehran Islamic Azad University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2200 6660
Email
info@iau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
personal
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mahtab Ghamgosar
Position
University student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Golsar Blvd
City
Rasht
Province
Guilan
Postal code
4166733658
Phone
+98 13 3377 6321
Email
mhtb.gh92@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mahtab Ghamgosar
Position
University student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Golsar Blvd.
City
Rasht
Province
Guilan
Postal code
4166733658
Phone
+98 13 3377 6321
Email
mhtb.gh92@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Shieh Morteza
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Dr shariati street, Gholhak, Yakhchal street, Islamic azad university of pharmaceutical sciences Branch
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 0051
Email
shiehmorteza@iaups.ac.ir
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