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Compariative evaluation of effect of chemical and Er,Cr:YSGG –assisted laser- bleaching on increasing of dentin sensitivity

Protocol summary

Study aim
Compariative evaluation of effect of chemical and Er,Cr:YSGG –assisted laser- bleaching on increasing of dentin sensitivity
Design
This clinical trial study will do in form of split mouth on 12 teeth ( 6 anterior teeth in maxilla and 6 anterior teeth in mandible ) in 5 volunteer persons who are match in age with each other that will reffer to restorative department of Hamedan dental faculty ( totally 60 teeth will come to study)
Settings and conduct
In each persion first chemical bleaching will do on 6 anterior teeth in one jaw with 40% bleaching gel for 45 minutes as factory direction on canine to canine teeth , then same bleaching gel will apply to 6 anterior teeth in apposite jaw and will use Er,Cr:YSGG laser.In both method dentin tooth sensitivity will measure with VAS chart befor treatment , immediately after treatment,24 houres , one week and one month after treatment after applying 5ml cold air with air pressure in 2 seconds from 1 cm of cervical of buccal part of the teeth
Participants/Inclusion and exclusion criteria
Inclusion : Having 18 years old at least, Having good general and oral health , Having 12 anterior teeth without filling and caries, Having no tooth sensitivity, No usege of antisensitivity productions at least 6 weeks befor treatment, No usege of analgesics 72 hours befor treatment Exclusion factors : Women in pregnancy and nursing , Severe internal discolouration (Tetracycline stain,Felorosis,pulpless teeth) , Having history of tooth whitening and antisensitivity treatment , Having tooth sensitivity , Having poor general and oral health , Smoking ,Having periodontal disease or undertreatment , Having parafunctional habits like bruxism , Usage of orthodontics appliance
Intervention groups
Chemical bleaching and Er,Cr:YSGG –assisted laser- bleaching
Main outcome variables
Increase dicrease and no change in dentin sensitivity

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190106042255N1
Registration date: 2019-03-03, 1397/12/12
Registration timing: registered_while_recruiting

Last update: 2019-03-03, 1397/12/12
Update count: 0
Registration date
2019-03-03, 1397/12/12
Registrant information
Name
Maryam Poulaki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3831 6830
Email address
poulaki.mp7@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2019-04-19, 1398/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compariative evaluation of effect of chemical and Er,Cr:YSGG –assisted laser- bleaching on increasing of dentin sensitivity
Public title
Compariative evaluation of effect of chemical and Er,Cr:YSGG –assisted laser- bleaching on increasing of dentin sensitivity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having 12 anterior teeth without filling and caries in upper and lower jaw Having 18 years old at least Having no tooth sensitivity No usege of antisensitivity productions at least 6 weeks befor treatment No usege of analgesics 72 hours befor treatment having good general and oral health
Exclusion criteria:
Women in pregnancy and nursing Severe internal discolouration (Tetracycline stain,Felorosis,pulpless teeth) Having history of tooth whitening and antisensitivity treatment Having tooth sensitivity Having poor general and oral health Smoking Having periodontal disease or undertreatment Having parafunctional habits like bruxism Usage of orthodontics appliance
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 5
More than 1 sample in each individual
Number of samples in each individual: 12
6 anterior teeth in maxilla and 6 anterior teeth in mandible
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Hamedan University of Medical Sciences
Street address
Shahid Fahmideh Ave
City
همدان
Province
Hamadan
Postal code
6517838677
Approval date
2018-12-21, 1397/09/30
Ethics committee reference number
IR.UMSHA.REC.1397.671

Health conditions studied

1

Description of health condition studied
tooth bleaching
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
dentin sensitivity
Timepoint
befor treatment, immediately after, 24 hours after , 1 week after and 1 month after treatment
Method of measurement
VAS analyse chart

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: chemical bleaching
Category
Treatment - Devices

2

Description
Intervention group: Er,Cr:YSGG –assisted laser- bleaching
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Dental faculty of Hamedan university of medical sciences
Full name of responsible person
Zahra Khamverdi
Street address
Shahid Fahmideh Ave
City
Hamedan
Province
Hamadan
Postal code
6517838677
Phone
+98 81 3838 1059
Fax
+98 81 3838 1085
Email
Dentistry@umsha.ac.ir
Web page address
http://dentistry.umsha.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Assistance of research and technology
Street address
Shahid Fahmideh
City
Hamedan
Province
Hamadan
Postal code
6517838677
Phone
+98 81 3838 0717
Fax
+98 81 3838 0130
Email
Dentistry@umsha.ac.ir
Web page address
http://research.umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Maryam Poulaki
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No 8, West Azad Ave
City
Hamedan
Province
Hamadan
Postal code
6516843814
Phone
+98 81 3831 6830
Fax
Email
poulaki.mp7@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Zahra Khamverdi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shahid Fahmideh Ave
City
Hamedan
Province
Hamadan
Postal code
6517838677
Phone
+98 918 312 2095
Email
khamverdi@umsha.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Maryam Poulaki
Position
Dental Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No 128, Azad Ave
City
Hamedan
Province
Hamadan
Postal code
6516843814
Phone
+98 81 3831 6830
Email
poulaki.mp7@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
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