Protocol summary

Summary
Abstract Objectives: The aim of the current study was to evaluate desensitizing effect of combined application of Diode Lasers (DLs) with two different output power levels and compare it with single DL therapy. Background: Diode lasers have been tested in various studies with different output powers and they have demonstrated an equal or better desensitizing effect than fluoride varnish, NK10% gel and Gloma. Material & methods: 8 patients with 62 hypersensitive teeth were selected and randomly divided into two groups: single group was treated with 3w DL, one time and the teeth in combined group were emitted tree times (the first time with 0.2w, then with 3w and the third time, 48 and 96 hours after the baseline visit with 0.2w DL). The amount of Dentine Hypersensitivity (DH) was evaluated, using tactile and thermal stimulus, immediately before and after irradiation, 1 week, 1 and 3 months after the first visit. Inclusion criterion: having at least 2 hypersensitive teeth. Exclusion criteria: cracked teeth; non vital teeth and history of systemic disease

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012101211086N1
Registration date: 2012-11-04, 1391/08/14
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-11-04, 1391/08/14
Registrant information
Name
Mohamad Mostafa Shadkar
Name of organization / entity
Dental School, Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8868 6254
Email address
mostafa.shadkar@chmail.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshty University of Medical of Sciences
Expected recruitment start date
2011-10-23, 1390/08/01
Expected recruitment end date
2013-02-19, 1391/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of low level laser therapy and combination therapy in dentinal hupersensitivity :a double blind clinical trial
Public title
Laser therapy in dentinal hypersensitivity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: having at least 2 hypersensitive teeth. Exclusion criteria: cracked teeth; non vital teeth and history of systemic disease.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 62
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
shahid beheshti university of medical science
Street address
Velenjak, shahid beheshti university of medical science
City
tehran
Postal code
Approval date
2011-10-03, 1390/07/11
Ethics committee reference number
90-1-92-7839-6629

Health conditions studied

1

Description of health condition studied
dentinal hypersensitivity
ICD-10 code
K03.8
ICD-10 code description
Sensitive dentine

Primary outcomes

1

Description
dentinal hypersenstivity
Timepoint
befor treatment,1 week,1month,3 month
Method of measurement
VAS

Secondary outcomes

empty

Intervention groups

1

Description
high level laser
Category
Treatment - Devices

2

Description
high level & low level laser therapy
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
dental faculty of shahid beheshti university of medical science
Full name of responsible person
Street address
City
tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
dental faculty of shahid beheshti university of medical science
Full name of responsible person
Fariba tadayon
Street address
Velenjek , dental school
City
tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
dental faculty of shahid beheshti university of medical science
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
shahid beheshti dental school
Full name of responsible person
dr zohre tabibzade noori
Position
professor
Other areas of specialty/work
Street address
Velenjak.shahid beheshti dental school
City
tehran
Postal code
Phone
+98 21 2242 1814
Fax
Email
ztabib@dent.sbmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
shahid beheshti dental school
Full name of responsible person
dr zohre tabibzade noori
Position
professor
Other areas of specialty/work
Street address
Velenjak.shahid beheshti dental school
City
tehran
Postal code
Phone
+98 21 2242 1814
Fax
Email
ztabib@dent.sbmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
shahid beheshti dental school
Full name of responsible person
mohamad mostafa shadkar
Position
student
Other areas of specialty/work
Street address
Velenjak,Shahid beheshti dental school
City
tehran
Postal code
Phone
00
Fax
Email
mostafa.shadkar@chmail.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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