Evaluation of the effectiveness of Elaeagnus angustifolia extract mucoadhesive buccal film in the treatment of oral recurrent aphthous ulcers: a randomized single-blind placebo-controlled clinical trial
Evaluation of the clinical effectiveness of Elaeagnus angustifolia extract mucoadhesive buccal film in the treatment of oral recurrent aphthous ulcers
Design
Two arm parallel group randomized placebo-controlled clinical trial, phase 3 on 34 patients. Block randomization method with blocks of 4 was used for randomization.
Settings and conduct
The study was performed at the dental clinic of Isfahan University of Medical Sciences.The subjects in experimental and control groups were instructed to use Elaeagnus angustifolia extract and placebo mucoadhesive buccal film, respectively, 4 times daily for 4 days. The severity of pain and size of the ulcer before the intervention (day 0) and at the beginning of the third and fifth days (end of treatment) were recorded for each patient.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Age of 18 years or more 2. Having 1 to 5 oral aphthous ulcers 3. No more than 48 hours of aphthous occurrence. Exclusion criteria: 1. Underlying aphthous ulcer-inducing disease 2. Pregnancy 3. Lactation 4. Receiving any anti-inflammatory or immunosuppressive drug within the last 2 weeks 5. Receiving any systemic antibiotic within the last 2 weeks 6. Treatment of aphthous ulcer with any other drug within recent 3 days
Intervention groups
Experimental group: mucoadhesive buccal film of Elaeagnus angustifolia extract (manufactured by the faculty of Pharmacy) standardized based on total phenol count(TPC), 4 times daily for 4 days. Control group: mucoadhesive buccal film of placebo (manufactured by the faculty of Pharmacy), 4 times daily for 4 days.
Main outcome variables
Ulcer size; pain severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150721023282N27
Registration date:2024-02-17, 1402/11/28
Registration timing:prospective
Last update:2024-02-17, 1402/11/28
Update count:0
Registration date
2024-02-17, 1402/11/28
Registrant information
Name
Rasool Soltani
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7067
Email address
soltani@pharm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-20, 1402/12/01
Expected recruitment end date
2024-09-20, 1403/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of Elaeagnus angustifolia extract mucoadhesive buccal film in the treatment of oral recurrent aphthous ulcers: a randomized single-blind placebo-controlled clinical trial
Public title
The effectiveness of russian olive in the treatment of oral aphthae
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 years or more
Having 1 to 5 oral aphthous ulcers
No more than 48 hours of aphthous occurrence
Not receiving any systemic antibiotic within the last 2 weeks
The block randomization method will be used using blocks of 4. For this, all cases of quadruple arrangement (including two drugs and two placebos) in a block will be designed and a code will be given to each block. The blocks will be selected using a random number table and patients are assigned to each of the two groups based on the order of the selected block.
Blinding (investigator's opinion)
Double blinded
Blinding description
Drug (Elaeagnus angustifolia extract) and placebo mucoadhesie buccal film will be fully similar and packaged in similar containers. The prescriber (physician) and the data analyst will be blind to the content of containers and intervention type.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Vice-chancellery for research, Isfahan University of Medical Sciences, Hezar-Jerib Ave., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2023-10-25, 1402/08/03
Ethics committee reference number
IR.MUI.PHANUT.REC.1402.029
Health conditions studied
1
Description of health condition studied
Oral recurrent aphthous ulcer
ICD-10 code
Recurrent
ICD-10 code description
K12.0
Primary outcomes
1
Description
Oral aphthous ulcer size
Timepoint
Before the intervention, 2 and 5 days after the start of intervention
Method of measurement
Dental caliper
2
Description
Pain severity
Timepoint
Before the intervention, 2 and 5 days after the start of intervention
Method of measurement
Visual Analog Scale
Secondary outcomes
1
Description
The number of cases with complete ulcer healing
Timepoint
End of ontervention (5th day)
Method of measurement
Observation
Intervention groups
1
Description
Intervention group: mucoadhesive buccal film of Elaeagnus angustifolia extract (manufactured by the faculty of Pharmacy) standardized based on total phenol count(TPC), 4 times daily for 4 days
Category
Treatment - Drugs
2
Description
Control group: mucoadhesive buccal film of placebo (manufactured by the faculty of Pharmacy), 4 times daily
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental Clinic of Isfahan University of Medical Sciences
Full name of responsible person
Rasool Soltani
Street address
Faculty of Dentistry, Isfahan University of Medical Sciences, Soffeh Avenue
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3303 3950
Email
soltani@pharm.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooy Javanmard
Street address
Isfahan University of Medical Sciencesو Hezar-Jerib Avenue
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Rasool Soltani
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Isfahan University of Medical Sciences, Hezar-Jerib Avenue
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7067
Email
soltani@pharm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Rasool Soltani
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7067
Email
soltani@pharm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Rasool Soltani
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7067
Email
soltani@pharm.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD