Protocol summary

Summary
We chose a group of patients who had totally 60 hypersensitive teeth. Each patient had at least 4 hypersensitive teeth we randomly put this 4 teeth in 4 group. (The patients must Have dentine hypersensitivity more than6 month Not using other hypersensitivity methods and the teeth not having gingivitis, calculus and decay) First group didn't receive any treatment . Next group treated with 5% sodium floured varnish ( A Durashield company production), third group received Nd: YAG laser (1wat, 2OHertz, 120second ) Assessment of the patient’s pain was done with cold air blast and visual analogs scale after stimulation by using an explorer and cold air before treatment, just after, 2 hours 1 week and second week after treatment.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201105316664N1
Registration date: 2011-06-14, 1390/03/24
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-06-14, 1390/03/24
Registrant information
Name
Ahmad Mogharehabed
Name of organization / entity
Isfahan Faculty Of Dentistry
Country
Iran (Islamic Republic of)
Phone
+98 31 1222 8106
Email address
mogharehabed@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Faculty of Dentistry, Isfahan University of Medical Sciences
Expected recruitment start date
2008-09-22, 1387/07/01
Expected recruitment end date
2009-03-19, 1387/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of effect of 5% sodium fluoride varnish and Nd: YAG laser and their combative use on dentine hypersensitivity treatment.
Public title
Comparative of effect of sodium fluoride varnish and Nd: YAG laser and their combative use on dentine hypersensitivity treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Each patient had at least 4 hypersensitive teeth ; Having dentin hypersensitivity more than6 month Not using other hypersensitivity methods. Exclusion criteria: Non-vital teeth; gingivitis; having calculus ; decayed teeth.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Faculty of Dentistry
Street address
Isfahan Faculty Of Dentistry, Hezarjarib,Isfahan
City
Isfahan
Postal code
Approval date
2008-07-27, 1387/05/06
Ethics committee reference number
387095

Health conditions studied

1

Description of health condition studied
Dentinal Hypersensitivity
ICD-10 code
k08.9
ICD-10 code description
Disorder of teeth and supporting structures, unspecified

Primary outcomes

1

Description
Pain
Timepoint
Before treatment, just after, 2 hours 1 week and second week after treatment
Method of measurement
Visual analogs scale

Secondary outcomes

empty

Intervention groups

1

Description
Control group:didn't receive any treatment
Category
N/A

2

Description
Intervention: treated with 5% sodium floured varnish ( A Durashield company production )
Category
Treatment - Drugs

3

Description
Intervention :received Nd: YAG laser (1wat, 2OHertz, 120second )
Category
Treatment - Drugs

4

Description
Intervention:Nd: YAG laser(1wat, 2OHertz, 120second ) +5% sodium floured varnish
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Periodentology Department, Faculty Of Dentistry
Full name of responsible person
Zeinab Abdi Zamhari
Street address
Isfahan Faculty Of Dentistry, Hezarjarib,Isfahan
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research,Faculty of Dentistry, Isfahan University of Medical Sciences
Full name of responsible person
Dr Savabi
Street address
Isfahan Faculty Of Dentistry, Hezarjarib,Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Faculty of Dentistry, Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Isfahan Faculty Of Dentistry
Full name of responsible person
Dr.Ahmad Mogharehabed
Position
Priodontologist
Other areas of specialty/work
Street address
Isfahan Faculty Of Dentistry, Hezarjarib,Isfahan
City
Isfahan
Postal code
Phone
+98 31 1792 2842
Fax
Email
mogharehabed@dnt.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan Faculty Of Dentistry
Full name of responsible person
Dr Ahmad Mogharehabed
Position
Priodontologist
Other areas of specialty/work
Street address
Isfahan Faculty Of Dentistry, Hezarjarib,Isfahan
City
Isfahan
Postal code
Phone
+98 31 1792 2842
Fax
Email
mogharehabed@dnt.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan Faculty Of Dentistry
Full name of responsible person
Dr Ahmad Mogharehabed
Position
Priodontologist
Other areas of specialty/work
Street address
Isfahan Faculty Of Dentistry, Hezarjarib,Isfahan
City
Isfahan
Postal code
Phone
+98 31 1792 2842
Fax
Email
mogharehabed@dnt.mui.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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