Comparative evaluation of the effects of laser Diode 980 nm and CPP-ACP paste on treatment of dentinal hypersensitivity
Design
Non randomized clinical trials with a control group , with parallel groups , a blind strain , randomized
Settings and conduct
In order to record the pain intensity of 96 dentin hypersensitivity teeth in 7 patients entered the study stimulation was performed using dry ice spray on a swab and VAS index, and the compliance was based on the primary VAS of the teeth And then a Nonrandomization took place.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:Patients reffering to dental faculty of isfahan university of medical sciences who have cervical dentin hypersensitivity in at least three teeth in three separate half jaw
Patients will be available for three months during the study and sign the form of consent form .
Teeth do not need restoration treatment
Erosion,attrition,dental cracks,pulpitis,periodontal disease
Active caries,restorated teeth,Crown fracture
Patients who have taken anti-histamine ,anti-depression and analgesics one month before the study
Pregnant and lactating women
Smokers
Patients who have received anti-Sensitivities toothpaste over the past 6 weeks.
Intervention groups
Intervention group1: The emission with a 1mm distance and 45 degree angle with the tooth surface for 30 seconds was radiated and reciprocating during the two sessions with a period of 1 weeks .
Intervention group2: GC paste Tooth Mousse ( according to the manufacturer 's instructions ) is placed on the surface of the tooth for 3 min and is asked to not do the swallowing act during this period and abstain from drinking and drinking in 30 minutes .
Control group: The teeth were not treated,and the direction of blindness of the study group was limited to stimulating the conditions under the radiation beam.
Main outcome variables
Improvement of dental hypersensitivity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150613022699N5
Registration date:2020-04-07, 1399/01/19
Registration timing:prospective
Last update:2020-04-07, 1399/01/19
Update count:0
Registration date
2020-04-07, 1399/01/19
Registrant information
Name
Reza Birang
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 5525
Email address
birang@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-18, 1399/01/30
Expected recruitment end date
2020-09-20, 1399/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of the effects of laser Diode 980 nm and CPP-ACP paste on treatment of dentinal hypersensitivity
Public title
Comparative evaluation of the effects of laser Diode 980 nm and CPP-ACP paste on treatment of dentinal hypersensitivity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion Criteria:Patients reffering to dental faculty of isfahan university of medical sciences who have cervical dentin hypersensitivity in at least three teeth in three separate half jaw
Patients will be available for three months during the study and sign the form of consent form .
Teeth do not need restoration treatment
Exclusion criteria:
Erosion,attrition,dental cracks,pulpitis,periodontal disease
Active caries,restorated teeth,Crown fracture
Patients who have taken anti-histamine ,anti-depression and analgesics one month before the study
Pregnant and lactating women
Smokers
Patients who have received anti-Sensitivities toothpaste over the past 6 weeks.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
10
More than 1 sample in each individual
Number of samples in each individual:
10
sensitive teeth
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The patient was informed about the therapeutic methods , including the treatment of laser therapy , the therapy with the CPP - ACP and the control group , but did not know what each tooth receives .
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
No. 373,Shahriar(12) Alley,Mir fendereski St
City
Isfahan
Province
Isfehan
Postal code
8163614754
Approval date
2019-11-14, 1398/08/23
Ethics committee reference number
IR.MUI.RESEARCH.REC.1398.452
Health conditions studied
1
Description of health condition studied
Dental Hypersensitivity
ICD-10 code
K08.9
ICD-10 code description
Disorder of teeth and supporting structures, unspecified
Primary outcomes
1
Description
Initial improvement of dental hypersensitivity
Timepoint
A dental sensitivity is measured in a month before and after therapeutic intervention every week.
Method of measurement
According to the visual analogue scale
Secondary outcomes
1
Description
Long-term improvement in dental hypersensitivity
Timepoint
One week,30 days and 60 days after the last therapeutic intervention
Method of measurement
According to the visual analogue scale
Intervention groups
1
Description
Intervention group: The emission with a 1mm distance and 45 degree angle with the tooth surface for 30 seconds was radiated and reciprocating during the two sessions with a period of 1 weeks .
Category
Treatment - Other
2
Description
Intervention group: GC paste Tooth Mousse ( according to the manufacturer 's instructions ) is placed on the surface of the tooth for 3 min and is asked to not do the swallowing act during this period and abstain from drinking and drinking in 30 minutes .
Category
Treatment - Other
3
Description
Control group: The teeth were not treated,and the direction of blindness of the study group was limited to stimulating the conditions under the radiation beam.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry,Isfahan University of Medical Sciences
Full name of responsible person
Narges Almasi
Street address
No. 373,Shahriar(12)Alley,Mir fendereski St
City
Isfahan
Province
Isfehan
Postal code
8163614754
Phone
+98 31 3667 1621
Email
narges.almas@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Reza Birang
Street address
Dental faculty,Isfahan university of Medical Sciences,Hezarjarib S
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 1707
Email
birang@dnt.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Narges Almasi
Position
Dental Intern
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No .373,Shahriar(12) Alley,Mir fendereski St
City
Isfahan
Province
Isfehan
Postal code
8163614754
Phone
+98 31 3667 1621
Email
narges.almas@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Reza Birang
Position
Professor of Periodontics
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental faculty,Isfahan university of Medical Sciences,Hezarjarib St
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 1707
Email
birang@dnt.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Narges Almasi
Position
Dental Intern
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No. 373,Shahriar(12) Alley,Mir fendereski St
City
Isfahan
Province
Isfehan
Postal code
8163614754
Phone
+98 31 3667 1621
Email
narges.almas@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