1-Determining the effectiveness of low diode laser in inhibiting nausea reaction in patients between 18 and 50 years old with mild, moderate and severe gag reflex requiring periapical (PA) intraoral radiographs
Design
Cross-sectional clinical trial in a single blind with a sample size of 35 people
Settings and conduct
The present study will be performed at Zanjan Dental School on 35 patients between 18 and 50 years old who have referred for periapical radiography of maxillary posterior teeth. In this study, after obtaining informed consent to participate in the study from clients, in order to eliminate the effect of anxiety as a disturbing factor, patients' level of anxiety is first determined by the Corah Dental Anxiety Scale and only people with the same level of anxiety should be included in the study. Two radiographs will be taken from each person. The first graphic will be done by placing the laser probe on the CV-24 acupuncture point (without laser radiation) and the second graphic after the low-power laser irradiation will be done on the CV-acupuncture point. 24 will be prepared
Participants/Inclusion and exclusion criteria
Sample inclusion criteria: being 18 to 50 years old / need to prepare intraoral radiographs for diagnosis and dental treatment / nausea during radiography / not pregnant / not breastfeeding
Intervention groups
Two radiographs will be taken from each person. The first graphic will be taken by placing the laser device probe on the CV-24 acupuncture point (without laser radiation) and the second graphic will be prepared after the low-power laser irradiation on the CV-24 acupuncture point
Main outcome variables
Anxiety and fear caused by dental procedures; Inhibition of gag reflex
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211217053437N1
Registration date:2021-12-23, 1400/10/02
Registration timing:prospective
Last update:2021-12-23, 1400/10/02
Update count:0
Registration date
2021-12-23, 1400/10/02
Registrant information
Name
Robab Noormohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3336 9810
Email address
dr.noormohammadi@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-27, 1400/10/06
Expected recruitment end date
2022-01-26, 1400/11/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Low Level Diode Laser (810nm) Therapy on CV-24 Acupuncture Point in Controlling Gag Reflex of Patients during Intraoral Radiographs
Public title
The Effect of Low Level Diode Laser (810nm) Therapy on CV-24 Acupuncture Point in Controlling Gag Reflex
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Need to prepare intraoral radiographs for diagnosis and dental treatment
Suffering from gag reflex while taking radiographs
Having satisfaction
Exclusion criteria:
being during breastfeeding
Being pregnant
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
35
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The present study will be performed as a one-way blind clinical trial (participants only). Two radiographs will be taken from each person. The first graphic will be taken by placing the laser device probe on the CV-24 acupuncture point (without laser radiation) and the second graphic will be prepared after the low-power laser irradiation on the CV-24 acupuncture point. will be
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences , Azadi Square, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
4514685748
Approval date
2021-12-06, 1400/09/15
Ethics committee reference number
IR.ZUMS.REC.1400.383
Health conditions studied
1
Description of health condition studied
Gag reflex
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Gag reflex rate based on Classification of Gagging Problem index
Timepoint
Before the intervention, after the placebo intervention, after the actual intervention
Method of measurement
Classification of Gagging Problem
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Selected specimens require periapical radiographs of the maxillary posterior teeth on both sides for dental diagnosis and treatment, and also have mild, moderate, or severe nausea reflexes based on the GFP classification index. After obtaining informed consent to participate in the study from the clients, two radiographs will be taken from each person. The first radiograph by placing the laser probe on the CV-24 acupuncture point (without laser radiation) and the second radiograph after laser irradiation CV-24 will be prepared at the acupuncture point. The laser used is a diode laser (Elexxion) with a continuous wavelength of 810nm. The tip of the probe rests on the skin at point CV-24 and is projected at 300 mW for 60 seconds. CV-24 is the point on the face in the center of the mentholabial groove, between the lower lip and chin.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Zanjan Dentistry School
Full name of responsible person
Robab Noormohammadi
Street address
School of Dentistry, Central Campus of Zanjan University of Medical Sciences, Above Ayatollah Mousavi Hospital, Dr. Sabouti Blvd., Zanjan
City
Zanjan
Province
Zanjan
Postal code
4514484475
Phone
+98 24 3314 8100
Email
dentist@zums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Alireza Shoghly
Street address
School of Dentistry, Central Campus of Zanjan University of Medical Sciences, Above Ayatollah Mousavi Hospital, Dr. Sabouti Blvd., Zanjan
City
Zanjan
Province
Zanjan
Postal code
4514484475
Phone
+98 24 3314 8100
Email
dentist@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Robab Noormohammadi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 7, Nasim Building, Deljoyi Ave., East Zeynabiye Blvd., Middle Saedi Town
City
Zanjan
Province
Zanjan
Postal code
4514667092
Phone
+98 24 3336 9810
Email
dr.noormohammadi@zums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Robab Noormohammadi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 7, Nasim Building, Deljoyi Ave., East Zeynabiye Blvd., Middle Saedi Town
City
Zanjan
Province
Zanjan
Postal code
4514667092
Phone
+98 24 3336 9810
Fax
Email
Dr.noormohammadi@zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Robab Noormohammadi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 7, Nasim Building, Deljoyi Ave., East Zeynabiye Blvd., Middle Saedi Town
City
Zanjan
Province
Zanjan
Postal code
4514667092
Phone
+98 24 3336 9810
Fax
Email
Dr.noormohammadi@zums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after unidentified individuals
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
Any kind of statistical analysis is allowed on the delivered data