To prepare a drug to reduce the gag reflex during dental procedures
Design
The clinical trial has a control group of 40 people and an intervention group of 40 people. It is performed by the laboratory technician and the medicine and placebo are provided to the executors completely randomly.
Settings and conduct
The extraction site is located in the Biochemistry and Nutrition Research Center for Metabolic Diseases and the production site is located in Yas Confectionery, Aran and Bidgol Branches. The jaws and faces of Nikan and Di are from Kashan city. First, the severity of gags or the absence of gags in the tonsils and soft palate is measured by Abslang and the results are recorded as nausea, low, moderate, severe in the data collection form. To be. Each person is then given a placebo pill or oak extract by a third party. This study will be double-blind and the drug code will not be known to the therapist until after the statistical analysis. The lozenges are sucked by the people for 5 minutes until they are completely dissolved. After the intervention with oak extract or placebo, the tonsils and soft palate areas are examined by the examiner to check the severity of the gag and the data are recorded in the data collection form.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- History of gag experience in dentistry
Exclusion criteria
1- Existence of any type of central and peripheral nerve lesions
2. Existence of any type of oral lesions
3. Taking any medicine
4- Suffering from gastrointestinal and respiratory diseases
5. Allergy to medicinal plants
Intervention groups
Candies containing 200 mg of oak extract as medicine and candies without extract containing sugar and water as a placebo are given to patients with gag.
Main outcome variables
Gag reflex
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130211012438N33
Registration date:2020-11-16, 1399/08/26
Registration timing:registered_while_recruiting
Last update:2020-11-16, 1399/08/26
Update count:0
Registration date
2020-11-16, 1399/08/26
Registrant information
Name
Mohsen Taghizadeh
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
taghizadeh_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2020-12-21, 1399/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of quercus extract on the gag reflex in dental patient
Public title
Investigation of the effect of oak extract (quercus) on nausea reflex
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
History of gag experience in dentistry
Exclusion criteria:
1- Existence of any type of central and peripheral nerve lesions
Existence of any type of oral lesions
Taking any medicine
Suffering from gastrointestinal and respiratory diseases
Allergy to medicinal plants
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The study will be a double-blind clinical trial on 80 patients referred to the radiology department. The clinical trial has a control group of 40 people and an intervention group of 40 people, double-blind, using a simple randomization method to randomize each candy. Are placed randomly in cellophane packaging and according to the identification of random numbers in the table of random numbers on the sample of candies, the coding is done by the laboratory technician and the medicine and placebo are provided to the executors. It becomes. Then the demographic information of the patients is prepared. And patients are randomly coded using a random number table.
Blinding (investigator's opinion)
Double blinded
Blinding description
Each of the candies is randomly placed in cellophane packaging and according to the identification of random numbers on the candy sample, the coding is done by the laboratory technician and the medicine and placebo are provided to the executors completely randomly. It should be noted that candies are matched in shape, color and weight.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Biomedical Research, Schools of Medicine and Dentistry, Kashan University of Med
Street address
5th of Qotb –e Ravandi Blvd. P.O.Box: 87159-81151, Kashan, IRAN
City
Kashan
Province
Isfehan
Postal code
8715981151
Approval date
2020-07-13, 1399/04/23
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1399.048
Health conditions studied
1
Description of health condition studied
Gag reflex
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting
Primary outcomes
1
Description
Gag reflex
Timepoint
Before examination and 5 minutes after using candies containing oak and placebo extracts
Method of measurement
Before and 5 minutes after sampling by Abslang. Criteria for measuring the severity of nausea: No nausea: No gag during contact with high risk surfaces of the mouth such as soft palate and tonsils Hakm: Gag formation during contact with high risk surfaces of the mouth such as soft palate and tonsils Medium: Gag formation during contact with low levels Risk of mouth such as hard palate and hard floor: Creating a gag before contact with an abscess, such as when opening the mouth and seeing an abscess
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Recipient of candy containing oak extract
Category
Treatment - Drugs
2
Description
Control group: Recipient of candy without oak extract, containing water and sugar
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Radiology Center, School of Dentistry, Kashan University of Medical Sciences
Full name of responsible person
Dr. Ameneh Taghdisi
Street address
5th of Qotb –e Ravandi Blvd. P.O.Box: 8715988141, Kashan, IRAN
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5558 2212
Email
dnt@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Alireza Moraveji
Street address
5th of Qotb –e Ravandi Blvd. P.O.Box: 8715988141, Kashan, IRAN
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5562 0045
Email
dnt@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Mohsen Taghizadeh
Position
full Profesor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Medicine, Qotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 36 1555 0021
Fax
+98 31 5554 0021
Email
taghizadeh_m@kaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mohsen Taghizadeh
Position
full Profesor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Medicine, Qotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 36 1555 0021
Fax
+98 31 5554 0021
Email
taghizadeh_m@kaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr.M.Taghizadeh
Position
PHD
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Kashan University Of Medical Sciences, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 36 1555 0021
Fax
Email
taghizadeh_m@kaums.ac.ir
Web page address
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