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Comparative efficacy of desensitizing gel(sensikin) and Nd:Yag laser in comparison with placebo for treatment of dentine hypersensitivity

Protocol summary

Summary
This randomized single blind placebo controlled clinical trial will be conducted to assess the efficacy of laser and gel in comparison with placebo in reducing the pain in patients who suffer from dentine hypersensitivity. The patients who have more than 1 month dentinal hypersensitivity and did not use other hypersensitivity methods will be recruited. We will exclude the pregnant women to avoid the probable side effects of laser; non-vital teeth, cracked teeth, deep restorations and crown and abutments, are other criteria for exclusion. Twenty patientseach have at least six teeth(120 tooth) with chronic hypersensitive teeth are being selected. In each patient 6 teeth will be randomly allocated into three intervention; first group will receive Nd:YAG laser (1W, 10Hz, 60s, two times); for second intervention, desensitizing gel (sensikin) administration and in the third group as control group without any active treatment, will be treated with laser device while it was off as placebo. Main study outcome is pain and its assessment is by visual analogue scale (VAS) after stimulation of sensitive tooth by using the sharp tip of explorer or a manual air blower. The measurements will be at: before treatment, immediately after the treatment, 1 week ,1 month, 3 months and 6 months after treatment. The effect of each intervention on pain reduction will be compared with control group.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201104104877N5
Registration date: 2011-04-28, 1390/02/08
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-04-28, 1390/02/08
Registrant information
Name
Jaber Yaghini
Name of organization / entity
Isfahan University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 31 1434 2136
Email address
j_yaghini@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
2010-11-22, 1389/09/01
Expected recruitment end date
2011-03-20, 1389/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative efficacy of desensitizing gel(sensikin) and Nd:Yag laser in comparison with placebo for treatment of dentine hypersensitivity
Public title
Comparative efficacy of gel and laser for treatment of dentine hypersensitivity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Having dentine hypersensitivity more than one month Not using other hypersensitivity methods such as toothpastes or tubules sealers Exclusion criteria: Pregnancy Non-vital teeth, cracked teeth, deep restorations, crown and abutments .
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Chancellery Of Isfahan Faculty Of Dentistry
Street address
Isfahan Faculty Of Dentistry
City
Isfahan
Postal code
8174673461
Approval date
2010-08-01, 1389/05/10
Ethics committee reference number
389218

Health conditions studied

1

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

Primary outcomes

1

Description
Pain
Timepoint
Before Treatment ,Immediately after, one week, one month ,3 months and 6 months after intervention.
Method of measurement
Visual Analogous Scale(VAS)

Secondary outcomes

empty

Intervention groups

1

Description
Use of Sensikin gel, three times a day for one week.
Category
Treatment - Drugs

2

Description
Use Of Nd:Yag Laser (1W, 10Hz, 60s, two times)
Category
Treatment - Devices

3

Description
with laser device while it was off as placebo
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Faculty of Dentistry, Isfahan University of Medical Sciences
Full name of responsible person
Fatemeh Shafiei
Street address
Isfahan Faculty Of Dentistry
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Faculty od Dentistry, Isfahan University of Medical Sciences
Full name of responsible person
Dr. Savabi
Street address
Faculty of Dentistry
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 od 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. Jaber Yaghini
Position
Priodotologist
Other areas of specialty/work
Street address
Periodentology Department, Faculty Of Dentistry
City
Isfahan
Postal code
Phone
+98 913 305 0508
Fax
Email
J_Yaghini@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 Moghar abed
Position
Priodontologist
Other areas of specialty/work
Street address
Priodontal Department, Faculty of Dentistry
City
Isfahan
Postal code
Phone
+98 31 1792 2842
Fax
Email
Mogharabed@dnt.mui.ac.ir
Web page address

Person responsible for updating data

Contact

Sharing plan

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