Comparative evaluation of the effect of Gluma Desensitizer and high power Diode Laser 980-nm and combination use of them on reduction of dentin hypersensitivity
Comparative evaluation of the effect of Gluma Desensitizer and Diode Laser 980-nm and combination use of them on reduction of dentin hypersensitivity
Design
Randomized clinical trial with control group, with parallel groups, single blinded
Settings and conduct
This study will be done on patients with dentin hypersensitivity referring to department of periodontics of Isfahan dental school. Effect of Gluma desensitizer and high power diode laser 980 nm and combination use of them will be evaluated. Statistical analyzer is blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients referring to department of periodontics of Isfahan Dental School who have 3 teeth with complaint of cervical dentin sensitivity that are not adjacent to each other. Patients should be available for three months during the study period and sign the informed consent form .The teeth do not need restorative treatment, people over 18 years old.
Exclusion criteria:
existence of caries, crack and pulpitis, cervically restored teeth, coronary fractures. Pregnant and lactating people, smoking patients, patients who have used anti-sensitive toothpaste or other medicines for the past 6 months, bleaching in past 6 months, unsuitable diet (use of sour and acidic foods), People who have high O'Leary index in follow up sessions (higher than 25%).
Intervention groups
1- Intervention group1: treatment with gluma desensitizer from Kulzer Company.
2- intervention group 2: treatment with high power diode laser (980 nm, 1 watt), with a distance of 1mm from the tooth and duration of 30 seconds
3- intervention group 3: treatment with combination of gluma desensitizer and high power diode laser 980 nm
4- control group: treatment without gluma desensitizer and laser, just applying conductor light of laser (off laser set) and scaling
Main outcome variables
Dentin sensitivity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120901010703N5
Registration date:2022-02-24, 1400/12/05
Registration timing:registered_while_recruiting
Last update:2022-02-24, 1400/12/05
Update count:0
Registration date
2022-02-24, 1400/12/05
Registrant information
Name
Narges Naghsh
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 5564
Email address
n_naghsh@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-20, 1400/10/30
Expected recruitment end date
2022-03-19, 1400/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of the effect of Gluma Desensitizer and high power Diode Laser 980-nm and combination use of them on reduction of dentin hypersensitivity
Public title
Comparative evaluation of the effect of Gluma Desensitizer and high power 980-nm Diode Laser and combination of them on reduction of dentin hypersensitivity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients referred to the general and specialized periodontics department of Isfahan Dental School have 3 teeth with complaints of cervical dentin sensitivity and sensitivity to cold stimuli that are not adjacent to each other. Patients should be available for three months during the study period and sign the informed consent form .Teeth do not need restorative treatment People over 18 years old
Exclusion criteria:
Caries, crack and pulpitis, Existence of active caries, cervically restored teeth, coronary fractures .Pregnant and lactating people smoking Patients and who have used anti-sensitive toothpaste and other medicines for the past 6 months. bleaching in past 6 months, diet (use of sour and acidic foods), People who have high O'leary index in follow up sessions (higher than 25%)
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
20
More than 1 sample in each individual
Number of samples in each individual:
3
3 nonadjacent hypersensitive teeth
Randomization (investigator's opinion)
Randomized
Randomization description
According to the number of available groups (4 groups for intervention and control), there are papers with the group name written on them and placed in a box. Each sample person picks a paper from the box and receives the desired treatment.
Blinding (investigator's opinion)
Single blinded
Blinding description
The data analyzer and patient do not know the type of received treatment
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Vice Chancellor for Research and Technology; Building No. 4; Isfahan University of Medical Sciences and Health Services; Hezar Jerib St.,
City
isfahan
Province
Isfehan
Postal code
۷۳۴۶۱۸۱۷۴۶
Approval date
2021-12-13, 1400/09/22
Ethics committee reference number
IR.MUI.RESEARCH.REC.1400.384
Health conditions studied
1
Description of health condition studied
Dentin hypersensitivity
ICD-10 code
K03.89
ICD-10 code description
Other specified diseases of hard tissues of teeth
Primary outcomes
1
Description
Amount of patient's pain (dentin hypersensitivity)
Timepoint
Before treatment, 15 minutes after treatment in the first session, one week after the first session, two weeks after the first session, one month after the first session, tree months after the first session
Method of measurement
Use of cold spray, use of air syringe of unit
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: intervention group 1 treatment with gluma desensitizer from Kulzer Company.gluma desensitizer apply on dry teeth 60 seconds and dry for 5 secondes.
Category
Treatment - Drugs
2
Description
Intervention group: intervention group 2 treatment with laser diode 980 nm (1 watt,980 nm) distance from tooth 1mm duration 30 seconds
Category
Treatment - Devices
3
Description
Intervention group: intervention group 3 treatment with combination of gluma desensitizer and followed by laser diode 980 nm . gluma desensitizer apply on dry tooth 60 seconds and dried for 5 seconds then diode laser (1 watt ,980nm) apply on tooth with distance 1mm for 30 seconds.
Category
Treatment - Devices
4
Description
Control group: control group treatment without gluma desensitizer and apply only conductor light of laser (off laser set) and with SRP on patients
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Periodontics, School of Dentistry, Isfahan University of Medical Sciences
Full name of responsible person
Azin Bazmara
Street address
Department of Periodontics; Dentistry School; Isfahan University of Medical Sciences and Health Services; Hezarjrib street
City
isfahan
Province
Isfehan
Postal code
۷۳۴۶۱۸۱۷۴۶
Phone
+98 913 328 4812
Email
a.bazmara@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mansour Siavash
Street address
Building No. 4; Vice Chancellor for Research and Technology; Isfahan University of Medical Sciences and Health Services; Hezar Jrib street
City
isfahan
Province
Isfehan
Postal code
۷۳۴۶۱۸۱۷۴۶
Phone
+98 31 3668 8138
Email
siavash@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Narges Naghsh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental faculty, Isfahan University of Medical Sciences, Hezarjerib street
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 1792 2870
Fax
+98 31 1668 7080
Email
n_naghsh@dnt.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
narges naghsh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Isfahan University of Medical Sciences, Hezarjrib street
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5564
Fax
Email
n_naghsh@dnt.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
narges naghsh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Isfahan University of Medical Sciences, Hezarjrib street
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5564
Email
n_naghsh@dnt.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available