Comparison of the Effectiveness of Combined Diode Laser and GLUMA Bonding Therapy with Combined Diode Laser and 5% Sodium Fluoride Varnish in Patients with Increased Dentin Sensitivity
Comparison of the effectiveness of combined Diode Laser and GLUMA bonding therapy with combined Diode laser and 5% sodium fluoride varnish in patients with increased dentin sensitivity referred to Laser dept., faculty of dentistry, Shahid Beheshti university of medical sciences, Tehran, Iran. 2019
Design
Clinical trial with control group - with parallel groups and single blind on 60 teeth
Settings and conduct
bonding group: a drop of GLUMA Desensitizer solution is applied on the buccal and lingual for 30 seconds .laser-bonding group: bonding was used according to the mentioned method, then the affected tooth was irradiated directly from the buccal lingual side with a wavelength of 660 nm and a power of 15 mW for 30 seconds, using caps D and E of KONFTEC diode laser, Klas-DX.varnish-laser group: 5% sodium fluoride solution was covered on the buccal and lingual surface by microwave, then the laser is irradiated with the mentioned method. Dental sensitivity was measured by VAS scale immediately after treatment and then 2, 7 and 30 days after treatment.
Participants/Inclusion and exclusion criteria
General health, having ≥ 3 teeth with hypersensitivity to contact stimuli or air blast and consent to 1-month follow-up / Exclusion criteria: having benign or malignant oral disease, long-term use of drugs, having decay in the affected tooth
Intervention groups
Three intervention groups including: bonding, laser-bonding, laser-varnish
One insensitive tooth in each patient as a control group
Main outcome variables
intensity of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201219049759N1
Registration date:2021-01-28, 1399/11/09
Registration timing:retrospective
Last update:2021-01-28, 1399/11/09
Update count:0
Registration date
2021-01-28, 1399/11/09
Registrant information
Name
Fahimeh Anbari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3776 2589
Email address
fahimeh.anbari@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-23, 1397/08/01
Expected recruitment end date
2019-04-19, 1398/01/30
Actual recruitment start date
2018-10-23, 1397/08/01
Actual recruitment end date
2019-04-19, 1398/01/30
Trial completion date
2019-12-22, 1398/10/01
Scientific title
Comparison of the Effectiveness of Combined Diode Laser and GLUMA Bonding Therapy with Combined Diode Laser and 5% Sodium Fluoride Varnish in Patients with Increased Dentin Sensitivity
Public title
Comparison of the Effectiveness of Combined Diode Laser and GLUMA Bonding Therapy with Combined Diode Laser and 5% Sodium Fluoride Varnish in Patients with Increased Dentin Sensitivity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
good general health
Having at least 3 teeth with hypersensitivity to contact stimulus or air blast
Agree to follow up for 1 month
Exclusion criteria:
Having benign or malignant oral disease
long-term use of the drug
having caries in the affected or adjacent tooth
enamel cracking
congenital defects in the enamel or dentin
tooth restoration
orthodontic procedures
periodontal disease
history of vital bleaching
history of Periodontal surgery or treatment of hypersensitivity during the last 6 months
history of non-surgical treatment of periodontal disease during the past 3 months
use of mouthwash containing allergens
pregnancy or lactation
use of antidepressants and analgesics
history of allergies to components Various treatment therapies
bruxism
abrasion
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
45
More than 1 sample in each individual
Number of samples in each individual:
3
Sample size At least 15 samples in each study group, a total of 45 samples (teeth with dentinal hypersensitivity) were determined so that there are at least 3 affected teeth in each participant.
Actual sample size reached:
60
More than 1 sample in each individual
Actual sample size in each individual:
3
Considering the possibility of non-cooperation of patients for 1-month follow-up, 60 samples were considered to start the study. All 60 samples participated in follow-up sessions until the end of the study.
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization by roll a dice method. This method is used for multi-group studies. Numbers 1 and 2 were considered for the first group, numbers 3 and 4 were considered for the second group, and numbers 5 and 6 were considered for the third group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients did not know how to treat each of the teeth included in the study, and laser eye goggles were used for all patients.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Chamran Highway, Velenjak St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2018-10-14, 1397/07/22
Ethics committee reference number
IR.SBMU.DRC.REC.1397.034
Health conditions studied
1
Description of health condition studied
Increased dentin sensitivity
ICD-10 code
ICD-10 code description
2
Description of health condition studied
diode laser
ICD-10 code
ICD-10 code description
3
Description of health condition studied
GLUMA bonding
ICD-10 code
ICD-10 code description
4
Description of health condition studied
5% Sodium Fluoride Varnish
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain intensity on the VAS scale
Timepoint
Before the intervention, immediately after the intervention and at intervals of 2, 7 days and 1 month after the intervention
Method of measurement
VAS scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1 (bonding): For this purpose, we use the solution of Kulzer GmbH, Germany GLUMA Desensitizer, which in a 5 ml bottle contains 5% glutaraldehyde, 35% HEMA-G and distilled water. One drop of the solution with a applicator is placed on the desired tooth for 30 seconds. It is then dried with a stream of air until the liquid layer on the tooth disappears and its surface loses its luster.
Category
Treatment - Other
2
Description
Intervention group (laser): For this purpose, a KONFTEC Corporation Taiwan KONFTEC Klas-DX diode laser device is used. The laser is applied to the surface of the affected tooth for 30 seconds from the buccal side and 30 seconds from the lingual side with a wavelength of 660 nm and a power of 15 mW using caps D and E, depending on the size of the tooth. The densities in these two caps are 1.8 and 6.9 J / cm2 respectively.
Category
Treatment - Other
3
Description
Intervention group (varnish): On the buccal and lingual surface of the target tooth is covered with a microbrush of 5% sodium fluoride solution (Asia Fluoride Chemical Chemistry, Iran). The patient will then be instructed to abstain from eating and drinking for up to one hour after the intervention and to brush for up to 12 hours.
Category
Treatment - Other
4
Description
Control group: In each patient, an insensitive tooth is randomly considered as a control.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Laser section and Clinics of the School of Dentistry of Shahid Beheshti University of Tehran
Full name of responsible person
Fahimeh Anbari
Street address
Shahid Beheshti Dental School, Daneshjoo Blvd., Shahid Chamran Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2217 5351
Email
DentIt@sbmu.ac.ir
Web page address
http://dentistry.sbmu.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Shahid Arabi Street next to Ayatollah Taleghani Hospital, Shahid Chamran Highway Yemen Street, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9780
Email
Mpajouhesh@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fahimeh Anbari
Position
َAssistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tehran, Evin, Shahid Chamran Highway, Daneshjoo Blvd., Shahid Beheshti University of Medical Sciences, 97 / 5000 Translation results School of Dentistry
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
098 21 22175351
Email
fahimeh.anbari@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fahimeh Anbari
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd., Shahid Chamran Highway, Evin, Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2217 5351
Fax
Email
fahimeh.anbari@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fahimeh Anbari
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd., Shahid Chamran Highway, Evin, Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2217 5351
Fax
Email
fahimeh.anbari@gmail.com
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