Evaluating the effect of mouthwash containing pomegranate peel total extract on gag reflex during impression taking in patients referring to north Khorasan dental school
Determining the effect of mouthwash containing total pomegranate peel extract on gag reflex during imperssion
Design
A clinical trial with a control group that is the same as the intervention group, with parallel, double-blind, randomized, phase 2 groups on 40 patients. Excel software rand function was used for randomization.
Settings and conduct
40 patients referred to the dental school with a diagnosis of severe nausea reflex by Abslang and according to the Dickinson table grading was jointly selected in both treatment and control groups over a period of one week and participated in the study.
While obtaining written consent and completing a pre-designed nausea reflex assessment questionnaire, one of the two available mouthwashes is randomly selected and applied in the first session and then molded by the molding material. Alginate will be taken and the results will be noted in the evaluation form while mentioning the desired mouthwash code.
Participants/Inclusion and exclusion criteria
1. Patients with severe nausea reflex due to stimulation of the salivary gland in the soft palate and tonsils 2. Patients' satisfaction to participate in the study؛
1.Patients with underlying diseases 3. Patients with a psychologic background include fear, anxiety, previous risky treatment experience who experience nausea reflex or its consequences.
Intervention groups
The intervention and control groups use mouthwash and placebo in the same way and 40 people with a time difference of one week
Main outcome variables
Gag reflex rate,the rate of recovery frome gag reflex
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210505051187N2
Registration date:2021-06-08, 1400/03/18
Registration timing:registered_while_recruiting
Last update:2021-06-08, 1400/03/18
Update count:0
Registration date
2021-06-08, 1400/03/18
Registrant information
Name
sahere soltani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3222 2361
Email address
sahere.soltani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-03, 1400/02/13
Expected recruitment end date
2021-06-13, 1400/03/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of mouthwash containing pomegranate peel total extract on gag reflex during impression taking in patients referring to north Khorasan dental school
Public title
Effect of pomegranate peel mouthwash in treatment of gag reflex
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with severe gag reflex due to stimulation of the abeslang in the soft palate and tonsils
Patients' satisfaction to participate in the study
Exclusion criteria:
Age
From 15 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomize, simple randomization will be used by shuffling the card. In this way, the number 1 is assigned to the first group and the number 2 assigned to the second group. The number 1 is written on 15 cards and the number 2 is written on 15 cards, then the cards are merged (shuffled) and one card is removed and The allocation is recorded and then the card is returned to the card collection.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants are aware of the type of intervention and will be given written consent. They only do not know about the drug and mouthwash, and the executors do not know about the mouthwash codes and the coding will be done by a technician and its analysis will be done by a statistical consultant.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of north khorasan university of medical science
Street address
Dr soltani office, ghiyam street, Telecommunication crossroads
City
Bojnourd
Province
North Khorasan
Postal code
۹۴۱۹۱۱۸۸۹۴
Approval date
2021-05-02, 1400/02/12
Ethics committee reference number
IR.NKUMS.REC.1400.020
Health conditions studied
1
Description of health condition studied
Gag reflex
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Gag teflex rate
Timepoint
7 days after using the first bottle
Method of measurement
Dickinson gag reflex ranking table
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Pomegranate peel whole mouthwash, 10%, 20 cc, 1 time, 40 seconds, spool Control group:
Category
Treatment - Drugs
2
Description
Control group: placebo mouthwash with permissible food color and taste similar to pomegranate peel full extarct mouthwash, 20 cc, 1 time, 40 seconds, reel
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
North Khorasan School of Dentistry
Full name of responsible person
Reza taghizade firouzjaie
Street address
North khorasan dentistry school
City
Bojnourd
Province
North Khorasan
Postal code
۹۴۱۹۱۱۸۸۹۴
Phone
+98 11 3252 2079
Email
Rezataghizade123@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Sahereh soltani
Street address
Arkan,north khorasan dental school
City
Bojnourd
Province
North Khorasan
Postal code
۹۴۱۹۱۱۸۸۹۴
Phone
+98 11 3252 2079
Email
Rezataghizade123@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bojnourd University of Medical Sciences
Proportion provided by this source
70
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
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Reza taghizade firouzjaii
Position
Scholar
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Arkan, north khorasan dental school
City
Bojnourd
Province
North Khorasan
Postal code
۹۴۱۹۱۱۸۸۹۴
Phone
+98 11 3252 2079
Email
Rezataghizade123@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Rezataghizade
Position
Scholar
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Arkan,north khorasan dental school
City
Bojnourd
Province
North Khorasan
Postal code
۹۴۱۹۱۱۸۸۹۴
Phone
+98 11 3252 2079
Email
Rezataghizade123@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Rezataghizade
Position
Scholar
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Arkan,north khorasan dental school
City
Bojnourd
Province
North Khorasan
Postal code
۹۴۱۹۱۱۸۸۹۴
Phone
+98 11 3252 2079
Email
Rezataghizade123@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