Protocol summary

Study aim
Evaluating the effect of benzydamine hydrochloride mouthwash on the rate of nausea reflex in comparison with the use of lidocaine spray in students of the School of Dentistry, Islamic Azad University in 2019
Design
Clinical trial with case and control group, with parallel groups, double-blind, randomized, phase 2 on 48 patients. This is a single-blind randomized controlled trial for patients. Subjects recruited were randomly assigned into two groups.
Settings and conduct
Among the eligible samples, 30 ​​randomly entered the study. Before each test, no information is given about the material and the method of operation. Tests will be conducted by a trained intern under the supervision of an oral disease specialist, who must be blind to medications. Individuals who show a GTPI rating above 2 after stimulating the Landmark markings shown in Table 1 will be included in the study and then randomly assigned to the case group (benzydamine) or to the control group (lidocaine spray). In the benzydamine group, 15ml of benzydamine hydrochloride mouthwash produced by Behvazan Daroo Company, are gargled for 1 minute, then removed and re-tested after 10 minutes. 4 puffs of 50% lidocaine spray, produced by Iran Daroo Company, are used and after 5 minutes, this test will be performed again. All tests are performed on the students of the Faculty of Dentistry of the Islamic Azad University of Tehran.
Participants/Inclusion and exclusion criteria
Entry requirements: People whose nausea is higher than 2 using the GTPI standard, Had breakfast two hours before the test Conditions for non-entry: Presence of any systemic diseases, drug allergy (Benzydamine or lidocaine), Pregnant and lactating women
Intervention groups
Case group (15ml of benzydamine hydrochloride ) and Control group (lidocaine spray 5%)
Main outcome variables
Application of benzydamine hydrochloride mouthwash reduces nausea reflexes

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190608043843N2
Registration date: 2020-06-30, 1399/04/10
Registration timing: prospective

Last update: 2020-06-30, 1399/04/10
Update count: 0
Registration date
2020-06-30, 1399/04/10
Registrant information
Name
simin lesan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 4571
Email address
s_lesan@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-05, 1399/04/15
Expected recruitment end date
2020-09-05, 1399/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effect of Benzydamine on the Severity of Gag Reflex
Public title
Evaluation of the Effect of Benzydamine on the Severity of Gag Reflex
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
People whose nausea rate is higher than 2 using the GTPI Standard Had breakfast two hours before the test
Exclusion criteria:
Having systemic diseases History of previous allergy to benzydamine or lidocaine Pregnancy and lactation
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
This is a single-blind randomized controlled trial for patients. Subjects recruited were consecutively and randomly assigned into two groups. The first group received benzidamine prior to procedure or whereas the second group received lidocaine.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participator: Befor each test, no information is given about the material and method of work to the patient to reduce the psychological and inductive effects as much as possible in this study. Clinical care: All tests will be performed by a trained intern under the supervision of an oral disease specialist, who must be blind to medications.
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 Dental Branch
Street address
No. 4, 9th Neyestan St., Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
1946853314
Approval date
2020-06-15, 1399/03/26
Ethics committee reference number
IR.IAU.DENTAL.REC.1399.069

Health conditions studied

1

Description of health condition studied
Gag Reflex
ICD-10 code
R00-R99
ICD-10 code description
Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified

Primary outcomes

1

Description
Reduction of Gag reflex
Timepoint
In the Benzydamine group before the intervention and 10 minutes after the intervention in the lidocaine group before the intervention and 5 minutes after the intervention, the nausea reflex is examined.
Method of measurement
Gag Trigger Point Index (GTPI)

Secondary outcomes

empty

Intervention groups

1

Description
Case group: Benzydamine hydrochloride mouthwash. In the benzydamine group, 15ml of benzydamine hydrochloride mouthwash produced by Behvazan Daroo Company is gargled for 1 minute, then removed and re-tested after 10 minutes.
Category
Prevention

2

Description
Control group: Use lidocaine spray. In the lidocaine group, on the mucosa of the desired areas, 4 puffs of 50% lidocaine spray produced by Iran Daroo Company are used, and after 5 minutes, the test will be performed again.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Dental Unit of Islamic Azad University of Tehran
Full name of responsible person
Simin Lesan
Street address
No. 4, 9th Neyestan St., Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
siminlesan@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Simin Lesan
Street address
No. 4, 9th Neyestan St., Pasdaran St.
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
siminlesan@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University
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
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Simin Lesan
Position
Assistant professor of Islamic Azad University, Dental branch of Tehran
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 4, 9th Neyestan St., Pasdaran St.
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
siminlesan@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Simin Lesan
Position
Assistant professor of Islamic Azad University, Dental branch of Tehran
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 4, 9th Neyestan St., Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
siminlesan@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Simin Lesan
Position
Assistant professor of Islamic Azad University, Dental branch of Tehran
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 4, 9th Neyestan St., Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
siminlesan@yahoo.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
Loading...