Protocol summary

Summary
This study will include 45 teeth with dentin hypersensitivity, using clinical and split mouth technique, in patients with periodontal diseases who have undergone periodontal care for at least a year. Dentin hypersensitivity will be evaluated using air and tactile stimulation tests. The study will be double-blind. Clinical applicability of the treatments will be evaluated by following process; the assessments will be recorded immediately following the treatment at minute 15 and in day 2, 7, and 30. 1-Air stimulus application test: the tooth being studied will be isolated and dried. Cold air is administered on the tooth surface at the distance of 1cm. Patient response will be recorded using visual analog scale (VAS). 2-Tactile stimulus application test: stimulation is made by periodontal probe scraping the radicular surface of exposed tooth. Patient response is recorded with VAS.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015102624715N1
Registration date: 2016-05-18, 1395/02/29
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-05-18, 1395/02/29
Registrant information
Name
Jamshid Poursamimi
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3335 3061
Email address
jampoursamimi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Qazvin University of Medical Sciences
Expected recruitment start date
2016-01-11, 1394/10/21
Expected recruitment end date
2016-05-05, 1395/02/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of 940 nm diode laser on the treatment of dentin hypersensitivity in periodontal maintenance patients
Public title
Efficacy of 940 nm diode laser on the treatment of dentin hypersensitivity in periodontal maintenance patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: individuals who have passed first phase of periodontal treatments and have dentin hypersensitivity in teeth with no caries, fracture; any clear tooth crack, fillings and periapical lesion, which will respond to both air and tactile stimuli application tests. Exclusion criteria: individuals with systemic diseases; allergy to materials used in the study; smokers; individuals with active periodontal diseases; pregnant and lactating women; patients who have received treatments related to increased tooth sensitivity; teeth with occlusal overload and recent occlusal re-adjustment therapy.
Age
From 22 years old to 57 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Qazvin University of Medical Sciences
Street address
Qazvin Dental Faculty
City
Qazvin
Postal code
3328554356
Approval date
2015-09-30, 1394/07/08
Ethics committee reference number
IR.QUMS.REC.1394.141

Health conditions studied

1

Description of health condition studied
Dentin hypersensitivity
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Dentin hypersensitivity
Timepoint
The assessments will be recorded immediately following the treatment at minute 15 and in day 2, 7, and 30.
Method of measurement
VAS( visual analogus scale)

Secondary outcomes

empty

Intervention groups

1

Description
In the first group, laser diodide of 940 nm wavelengths with uninitiated 400mm fibers and power 1.5 Watt with continuous radiation mode of two 30 seconds intervals will be used.
Category
Treatment - Other

2

Description
In secound group(positive control), potassium fluoride gel 2% will be used.
Category
Treatment - Drugs

3

Description
In placebo group, both laser and potassium fluoride gel 2% will be placebo
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Qazvin Dental Faculty
Full name of responsible person
Tahere Pourseyedian
Street address
Qazvin
City
Qazvin

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Taghi Naserpoor
Street address
Qazvin
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Tahere Pourseyedian
Position
Postgraduated student of periodontics
Other areas of specialty/work
Street address
Qazvin
City
Qqazvin
Postal code
23476543832
Phone
+98 28 3335 3061
Fax
+98 28 3335 3061
Email
th.1362@yahoo.com
Web page address
qums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Jamshid Poursamimi
Position
Aassistance prof.
Other areas of specialty/work
Street address
Qazvin
City
Qqazvin
Postal code
2345367544
Phone
+98 28 3335 3061
Fax
+98 28 3335 3061
Email
jampoursamimi@qums.ac.ir
Web page address
qums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Tahere Pourseyedian
Position
Postgraduated student of perio
Other areas of specialty/work
Street address
Qazvin University of Medical Sciences
City
Qqazvin
Postal code
2346484567
Phone
+98 28 3335 3061
Fax
+98 28 3335 3062
Email
th.1362@yahoo.com
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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