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The Effect of Capsaicin Oral Solution in The Treatment of Burning Mouth in Patients Attending School of Dentistry and Affiliated Hospitals of Tehran Islamic Azad University of Medical Sciences

Protocol summary

Study aim
Determining the effect of Capsaicin and placebo oral solution in patients with burning mouth in patients referred to the School of Dentistry and affiliated hospitals of Tehran Islamic Azad University of Medical Sciences in the academic year 2022-2023
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2-3 on 22 patients. Excel software rand function was used for randomization
Settings and conduct
School of Dentistry and Affiliated Hospitals of Tehran Islamic Azad University, Blinding patient and outcome assessor, Coding oral solutions by a person outside the research team, Fill in forms 1, 2 and 3 on day 0, fill in forms 4 and 5 on day 30, measure non-stimulating saliva
Participants/Inclusion and exclusion criteria
Inclusion criteria: existence of daily sensation of bilateral burning in the mouth continuously (4 to 6 months) and without the appearance of specific clinical symptoms, improvement of oral burning symptoms by eating food or drinking water; non-interference of burning mouth with the patient's sleep. Exclusion criteria: presence of any throat and nose lesions clinically; any local or systemic disease; use of herbal or chemical drugs; hypersensitivity reactions, physical or chemical factors; complete dental prosthesis; bad oral habits such as Bruxism; oral mucosal diseases such as Lichen planus; benign migratory glossitis, and bacterial, fungal, and viral infections; neurological problems, endocrine disorders, anemia, gastrointestinal diseases, malnutrition; pregnancy or lactation, and allergies to peppers.
Intervention groups
Intervention group: 11 eligible volunteers with burning mouth between 30 and 80 years old referred to the School of Dentistry of Tehran Islamic Azad University of Medical Sciences who have completed the voluntary consent form. Intervention: Capsaicin oral solution
Main outcome variables
Improvement of burning mouth

General information

Reason for update
Acronym
VAS
IRCT registration information
IRCT registration number: IRCT20220117053748N1
Registration date: 2022-02-01, 1400/11/12
Registration timing: prospective

Last update: 2022-02-01, 1400/11/12
Update count: 0
Registration date
2022-02-01, 1400/11/12
Registrant information
Name
Kimia Ghods
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2269 2735
Email address
kimiaghods2@gmali.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-09, 1400/11/20
Expected recruitment end date
2022-03-06, 1400/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Capsaicin Oral Solution in The Treatment of Burning Mouth in Patients Attending School of Dentistry and Affiliated Hospitals of Tehran Islamic Azad University of Medical Sciences
Public title
The Effect of Capsaicin on Burning Moth
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Absence of systemic disease Existence of daily sensation of bilateral burning mouth continuously (4 to 6 months) and without obvious clinical symptoms Improve the symptoms of burning mouth by eating food or drinking water Non-interference of burning mouth with the patient's sleep
Exclusion criteria:
Existence of any throat and nose lesions clinically Existence of any local factor or systemic disease Herbal or chemical drugs consumption Existence of hypersensitivity reactions Existence of physical or chemical agents Existence of complete dentures, bad oral habits such asBruxism, oral mucosal diseases such as lichen planus, benign migratory glossitis, and bacterial, fungal, and viral infections.Neurological problems, endocrine disorders, anemia, gastrointestinal diseases, malnutrition, pregnancy and lactation, and pepper allergy Existence of bad oral habits like Bruxism Existence of oral mucosal diseases such as Lichen planus, benign migratory glossitis, and bacterial, fungal, and viral infections Existence of neurological problems Existence of endocrine disorders Existence of anemia Existence of gastrointestinal diseases Existence of malnutrition Pregnancy and lactation Existence of pepper allergy
Age
From 30 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 22
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation of participants in the study by the group statistician to random 4 blocks will be done using the Rand option of Excel software. Then, according to the number of samples, envelopes will be prepared in the package and given to the random person. Prior to treatment, the oral solution of capsaicin and placebo will be coded by someone outside the clinical research team. Therefore, both the patient and the evaluator will be blind.
Blinding (investigator's opinion)
Double blinded
Blinding description
Prior to treatment, the oral solution of capsaicin and placebo will be coded by someone outside the clinical research team. Therefore, both the participants in the study and the outcome evaluator will be blind.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Islamic Azad University - Dental Branch Tehran - Iran
Street address
No. 9, 9th Neystan Street, Pasdaran Street
City
Tehran
Province
Tehran
Postal code
1931843511
Approval date
2022-01-10, 1400/10/20
Ethics committee reference number
IR.IAU.DENTAL.REC.1400.155

Health conditions studied

1

Description of health condition studied
Burning mouth
ICD-10 code
T28.0
ICD-10 code description
Burn of mouth and pharynx

2

Description of health condition studied
Dry mouth
ICD-10 code
R68.2
ICD-10 code description
Dry mouth, unspecified

Primary outcomes

1

Description
Burning score in the standard burning mouth questionnaire
Timepoint
Filling in the mouth burning questionnaire at the beginning of the study (before the intervention) and on days 0 and 30 after starting the capsaicin solution
Method of measurement
Standard burning mouth questionnaire

Secondary outcomes

1

Description
Amount of Xerostomia
Timepoint
At the beginning of the study (before the intervention) and day 0, 30 after the start of capsaicin solution
Method of measurement
Standard dry mouth questionnaire

Intervention groups

1

Description
Intervention group: Capsaicin oral solution using 10% extract of a mixture of coriander (Coriandrum sativum L.) and Hypericum perforatum (Hypericum perforatum L.) which was prepared by accelerated solvent method and 0.25% of Capsaicin in hydroalcoholic base with مiquid fructose solution and polyethylene glycol are formulated and standardized based on the presence of Capsaicin. This solution is diluted 20 drops of medicine or placebo in 20 cc of water three times a day for 30 days and gargle for at least 2 minutes.
Category
Treatment - Drugs

2

Description
Control group: This oral solution has been formulated using permitted pharmaceutical food dyes based on hydroalcoholic as well as liquid fructose solution and PEG, but without the use of coriander fruit extract, Hypericum perforatum and Capsaicin. This solution is diluted 20 drops of medicine or placebo in 20 cc of water three times a day and gargle for at least 2 minutes.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
School of Dentistry and Affiliated Hospitals, Islamic Azad University of Tehran Medical Sciences
Full name of responsible person
Kimia Ghods
Street address
No. 9, 9th Neystan Street, Pasdaran Street
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2276 3463
Email
alaee.a@iautmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Arezoo Alaee
Street address
No. 9, 9th Neystan, Pasdaran St.
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2276 3463
Email
alaee.a@iautmu.ac.ir
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
Kimia Ghods
Position
Dental student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 9, 9th Neystan Street, Pasdaran Street
City
Tehran
Province
Tehran
Postal code
1931843511
Phone
+98 21 2269 2735
Email
kimiaghods2@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Kimia Ghods
Position
Dental student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 9, 9th Neystan Street, Pasdaran Street
City
Tehran
Province
Tehran
Postal code
1931843511
Phone
+98 21 2269 2735
Email
kimiaghods2@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Kimia Ghods
Position
Dental student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 9, 9th Neystan Street, Pasdaran Street
City
Tehran
Province
Tehran
Postal code
1931843511
Phone
+98 21 2269 2735
Email
kimiaghods2@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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