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Comparison of the effect of Nd:YAG laser, Diode laser and CPP/ACP on treatment of patient with dentin hypersensitivity: a randomized clinical trial

Protocol summary

Summary
Objectives: To assess the effect of Nd:YAG laser, Diode laser and CPP/ACP on treatment of patient with dentin hypersensitivity. Design: A randomized clinical trial. Setting and conduct: The eligible patients dentin hypersensitivity who will refer to the School of Dentistry during the study period will be enrolled into the trial. Inclusion criteria: Age of 18 to 65 years; dentin hypersensitivity; suitable plaque index with no packet. Exclusion criteria: Pregnancy or breastfeeding; systemic disease; periodontal surgery during the last 6 months; whitening treatment of teeth in the last 6 months; using anti-hypersensitivity and anti-inflammatory mouthwash or tooth paste during the last 72 hours; using anti-depressive drugs; using orthodontic devices; the presence of fractures, cracks, decay and deep repair in the teeth and adjacent teeth. Intervention group 1: Two teeth in every patients are treated with Nd:YAG laser, with 1064 nm wave length, power of 1 W; pulse width of 300 sµ, frequency of 15 Hz, irradiation time of 30 seconds through contact mode, with a hand piece of 300 µ and a density of 294 j/cm with sweeping movement. Intervention group 2: Two teeth in every patients are treated with Diode laser, with 940 nm wave length, power of 1 W; pulse width of 300 sµ, frequency of 15 Hz, irradiation time of 60 seconds through contact mode, with a hand piece of 400 µ and a density of 294 j/cm with sweeping movement. Intervention group 3: Two teeth in every patients are treated with casein phosphopeptide phosphate calcium amorphic jell for 5 minutes. Control group: Two teeth in every patients are considered as control group without treatment. Primary outcome: Assessing the dentin hypersensitivity with visual analog scale (VAS) one hour after intervention. Randomization: Eight teeth are selected in each patient. Then, every two teeth are randomly allocated through drawing of lots to intervention groups (three groups) and control group (one group). Blinding: Not possible.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201707269014N176
Registration date: 2017-07-31, 1396/05/09
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-07-31, 1396/05/09
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2016-10-31, 1395/08/10
Expected recruitment end date
2017-08-25, 1396/06/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Nd:YAG laser, Diode laser and CPP/ACP on treatment of patient with dentin hypersensitivity: a randomized clinical trial
Public title
Comparison of the effect of Nd:YAG laser, Diode laser and CPP/ACP on treatment of patient with dentin hypersensitivity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age of 18 to 65 years; dentin hypersensitivity; suitable plaque index with no packet. Exclusion criteria: Pregnancy or breastfeeding; systemic disease; periodontal surgery during the last 6 months; whitening treatment of teeth in the last 6 months; using anti-hypersensitivity and anti-inflammatory mouthwash or tooth paste during the last 72 hours; using anti-depressive drugs; using orthodontic devices; the presence of fractures, cracks, decay and deep repair in the teeth and adjacent teeth.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 7
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: Eight teeth are selected in each patient. Then, every two teeth are randomly allocated through drawing of lots to intervention groups (three groups) and control group (one group). Blinding: Not possible.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Approval date
2016-10-29, 1395/08/08
Ethics committee reference number
IR.UMSHA.REC.1395.335

Health conditions studied

1

Description of health condition studied
Dentin hypersensitivity
ICD-10 code
K03.8
ICD-10 code description
Other specified diseases of hard tissues of teeth

Primary outcomes

1

Description
Assessing the dentin hypersensitivity
Timepoint
one hour after intervention
Method of measurement
with visual analog scale (VAS)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Two teeth in every patients are treated with Nd:YAG laser, with 1064 nm wave length, power of 1 W; pulse width of 300 sµ, frequency of 15 Hz, irradiation time of 30 seconds through contact mode, with a hand piece of 300 µ and a density of 294 j/cm with sweeping movement.
Category
Treatment - Other

2

Description
Intervention group 2: Two teeth in every patients are treated with Diode laser, with 940 nm wave length, power of 1 W; pulse width of 300 sµ, frequency of 15 Hz, irradiation time of 60 seconds through contact mode, with a hand piece of 400 µ and a density of 294 j/cm with sweeping movement.
Category
Treatment - Other

3

Description
Intervention group 3: Two teeth in every patients are treated with casein phosphopeptide phosphate calcium amorphic jell for 5 minutes.
Category
Treatment - Drugs

4

Description
Control group: Two teeth in every patients are considered as control group without treatment.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
School of Dentistry
Full name of responsible person
Mohammad Farokhi Rad
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
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 and Technology, Hamadan 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
School of Dentistry
Full name of responsible person
Mohammad Farokhi Rad
Position
Student of Dentistry
Other areas of specialty/work
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0572
Fax
Email
mfarokhi829@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Dentistry
Full name of responsible person
Dr Zahra Khamverdi
Position
Orthodontics
Other areas of specialty/work
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0572
Fax
Email
9183122095
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.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
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