Comparison of the effectiveness of Cyanoacrylate with Dentin bonding on the Rate of Changes in Tooth Sensitivity in patinet with Dental Sensitivity(clinical trials)
Comparison of the Effect of Cyanoacrylate with Dentin bonding on the rate of changes in Dental Sensitivity
Design
Phase three clinical trial with control group, with parallel groups, not blind , randomized into two groups.
Settings and conduct
This clinical trial study will be done on 40 patients referred to the periodontal department of the dental school Islamic Azad University and with complainment of tooth sensitivity will be performed in 2021.Sensitivity is measured at the beginning of the course and 1day and 7days after intervention with visual analog scale ,Patients do not know in which treatment group they are .This test includes a score from 1 to 10 that the patient gives to her/his tooth sensitivity in response to air test.
Participants/Inclusion and exclusion criteria
1.Informed consent 2.complaining of dental sensitivity 3.Initial sensitivity more than 4 based on visual analog scale.
1.Pregnancy and lactation 2.Restored or cracked teeth
Intervention groups
This clinical trial parallel not blind study compares between 2 groups that first one receiving Cyanoacrylate and control group receiving Dentin bonding.A total of 40 patients (men and women) participate in this study and volunteers must have at least one tooth with sensitivity more than 4 score based on visual analog scale (vas) . Participants randomly divide into two groups receiving Cyanoacrylate (applying by microbrush on cervical region of sensitive tooth) and control group receiving Dentin bonding (applying by microbrush on cervical region of sensitive teeth then wait for 20 seconds and then drying with air spray and placing again and curing with light cure).Secondary sensitivity is measured at the end of 24 hours and 1week after intervention .
Main outcome variables
Rate of changes in dental sensitivity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120220009088N4
Registration date:2021-03-16, 1399/12/26
Registration timing:prospective
Last update:2021-03-16, 1399/12/26
Update count:0
Registration date
2021-03-16, 1399/12/26
Registrant information
Name
Saeed Sadat Mansouri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2291 9455
Email address
s_sadatmansouri@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-03, 1400/01/14
Expected recruitment end date
2021-04-21, 1400/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of Cyanoacrylate with Dentin bonding on the Rate of Changes in Tooth Sensitivity in patinet with Dental Sensitivity(clinical trials)
Public title
Comparison of the effectiveness of Cyanoacrylate with Dentin bonding on the Rate of Changes in Tooth Sensitivity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent
Vital dental pulp
The initial sensitivity is greater than 4based on visual analog scale (vas)
Exclusion criteria:
Pregnancy and lactation
Restored or cracked teeth
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
simple random method ( code is assigned to each sample) and using SPSS statistical software .
Blinding (investigator's opinion)
Not blinded
Blinding description
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 Medical Sciences , Tehran
Street address
Pasdaran Ave , neyestan 9th, Tahran Azad Dental School
City
Tehran
Province
Tehran
Postal code
١٩٤٦٨٥٣٣١٤
Approval date
2019-10-22, 1398/07/30
Ethics committee reference number
IR.IAU.DENTAL.REC.1398.045
Health conditions studied
1
Description of health condition studied
Dental Sensitivity
ICD-10 code
K03.89
ICD-10 code description
Other specified diseases of hard tissues of teeth
Primary outcomes
1
Description
The Rate of changes in Dental Sensitivity
Timepoint
At the begining ,1day and 7days after intervention
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Initial sensitivity is measured by air test and based on visual analog scale (vas) then Cyanoacrylate manufactured by Glustick in Canada is placed on cervical region of sensitive tooth.Secondry sensitivity will measured by air test and based on vas 24 hours and 7days after intervention.
Category
Other
2
Description
Control group: Initial sensitivity is measured by air test and based on visual analog scale (vas) then Dentin bonding that manufactured in Corary company in Japon is placed on cervical region of sensitive tooth then wait for 20seconds and then dry it with poar then apply it again and cure it with light cure. Secondry sensitivity will measured by air test and based on vas 24 hours and 7days after intervention.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Periodontology, School of Dentistry, Islamic Azad University of Tehran
Full name of responsible person
Parya Dadehbeiglou
Street address
Pasdaran Ave, neyestan 9th, Tehran Azad Dental School
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
Drsaeed_sadatmansouri@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Arash Aizi
Street address
Pasdaran Ave,neyestan 9th,Tehran Azad Dental School
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
drarashazizi@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
Saeed Sadat Mansouri
Position
Periodontics Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
PasdaranAve,neyestan 9th,Tehran Azad Dental School
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
0998 21 22564571
Email
s_sadatmansouri@dentaliau.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Saeed Sadat Mansouri
Position
Periodontics Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Pasdaran Ave,neyestan 9th,Tehran Azad Dental School
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
s_sadatmansouri@dentaliau.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Parya Dadehbeiglou
Position
Dental student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
PasdaranAve,neyestan 9th,Tehran Azad Dental School
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
paryabeiglou@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