Comparison of Effect of Fluoride Varnish, Gluma and Er: Cr: YSGG Laser on dentin hypersensitivity in patients with sensitive teeth: a randomized clinical trial.
Determine the 6-month effect of Er: Cr: YSGG laser and several dentinal sensitisers in the treatment of dentinal hypersensitivity
Design
Clinical trials, with parallel, double blind, randomized groups.
175 dentin hypersensitivity teeth will be divided into 5 groups based on the treatment protocol and the results will be compared.
Settings and conduct
Location: Hamadan University of Medical Sciences
Method: First, the participants will be assigned to the groups according to their initial sensitivity. After randomization, the teeth will randomly be divided into five groups based on the received treatment.
Patients will be followed after 1 week, 1 month and 6 months after treatment. At each appointment, the evaluation process will be repeated for each patient and the patient's VAS score will be recorded.
Finally, the scores obtained from the patients in each group will be statistically analyzed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Good general health; without decay or restoration; without previous treatment; Age and mental ability to determine pain score; No history of bleaching.
Non-inclusion criteria:People with chronic diseases; People who have used toothpaste or desensitiser mouthwash for the past 3 months; People who have had periodontal surgeries in the last 6 months;non vital teeth or vital teeth that have cracks, previous repairs, decay lesions or active periodontal disease; People with deep caries in the vicinity of a sensitive tooth
Intervention groups
Intervention group1: Er: Cr: YSGG laser expose to the sensitive teeth.
Intervention group2: varnish fluoride will rub to the sensitive teeth.
Intervention group3: first varnish rub on the sensitive teeth, and then laser will be exposed.
Intervention group4: gluma will rub on the sensitive teeth.
Intervention group5: first gluma rubbed on the sensitive teeth, and then laser will be exposed.
Main outcome variables
tooth sensivity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190422043343N1
Registration date:2019-07-19, 1398/04/28
Registration timing:retrospective
Last update:2019-07-19, 1398/04/28
Update count:0
Registration date
2019-07-19, 1398/04/28
Registrant information
Name
Mahsa Forouzande
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 6410
Email address
mahsaforouzande@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-04, 1398/02/14
Expected recruitment end date
2019-06-19, 1398/03/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Effect of Fluoride Varnish, Gluma and Er: Cr: YSGG Laser on dentin hypersensitivity in patients with sensitive teeth: a randomized clinical trial.
Public title
The Effect of Different Desensitiser Protocols on Dentin Hypersensitivity Treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Good general health without any known allergies to commercial dental products
The teeth do not have any decay or restoration
The patient has not previously received any treatment for dentin hypersensitivity
The patient has the ability to determine the pain score in the VAS in terms of age and mentality
Patients do not have a history of receiving bleaching treatments
Exclusion criteria:
People with chronic disease with daily episodes of pain that use analgesics, antihistamines, anti-inflammatory drugs, or analgesics during the last 72 hours
People who have used toothpaste or antisensivity mouthwash for the last 3 months.
People who have had periodontal surgeries in the last 6 months.
non vital teeth or vital teeth with crack, previous restoration, decay lesions, or active periodontal disease. patients without active periodontal disease will remain active in the study
People with deep carries adjacent to a sensitive tooth that have a chance of confusing pain with sensitive tooth pain
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
35
More than 1 sample in each individual
Number of samples in each individual:
5
The teeth with dentin hypersensitivity that can vary from one tooth to all teeth and in the above box, an average of 5 teeth were mentioned
Randomization (investigator's opinion)
Randomized
Randomization description
At first, participants are classified according to their initial sensitivity and then randomly divided into random classes in a randomized block to ensure that each group is in the same state of origin in terms of initial sensitivity. Block size and randomization method will be determined by another person Other than the therapists and evaluators. Given the fact that the stimulus air flow is effective in evaluating the effectiveness of the therapeutic methods compared to the adjacent teeth, only one treatment will be used in each jaw quadrant.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a double-blind study. One operator irradiate laser and apply densitisers , while the other operator will assess the sensitivity. Also, patients will not be aware of the treatment they will receive and on the teeth Patients whose therapeutic protocol does not include lasers will be targeted by the aiming beam.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
Secondary trial Id
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hamadan University of Medical Sciences
Street address
Shahid Fahmideh
City
Hamadan
Province
Hamadan
Postal code
6516647447
Approval date
2019-05-05, 1398/02/15
Ethics committee reference number
IR.UMSHA.REC.1398.095
Health conditions studied
1
Description of health condition studied
Dentin hypersensivity
ICD-10 code
K03.8
ICD-10 code description
Other specified diseases of hard tissues of teeth
Primary outcomes
1
Description
Tooth sensitivity amount
Timepoint
After 1 week, 1 month and 6 months
Method of measurement
VAS score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1:laser: Laser Er, Cr: YSGG (Waterlase, Biolase Technology, Irvine, CA) perpendicular to the dentin surface by moving scanning movements at a distance of 1 mm with zero percent of air and water for 30 seconds with a frequency of 20 Hz and a power of 0.25 W (44.3J / cm2) whit M Z6 sapphire tip with a diameter of 600 micron and a length of 6 mm will be exposed on the sensitive teeth.
Category
Treatment - Devices
2
Description
Intervention group 2 (fluoride varnish):A cotton roll for isolating the environment and preventing the varnish mix with saliva will be used. Then, a thin layer of Fluoride varnish (Ivoclar Vivadent), will be applied on the surface of the tooth with a disposable microbrush in accordance with the factory's instructions. Two to three layers of varnish will be applied to the surface of the teeth on the same day. Patients will be told to stop taking any food or carbonate drink for an hour after using varnish.
Category
Treatment - Drugs
3
Description
Intervention group 3 (fluoride varnish and laser): The varnish will be used similarly to the method used in group 2 on the teeth surface, and the varnish will remain in place for 60 seconds, and then the laser will be exposed with the same radiant profile of the group 1 on its surface.
Category
Treatment - Drugs
4
Description
Intervention group 4 (Gluma): A cotton roll for rubbing the Gluma (Heraeus Kulzer GmbH, Hanau, Germany) will be used with a gentle but firm motion on the tooth surface. After 30 to 60 seconds, the dentin will dry completely until The fluid will disappear and the surface will lose its gloss state.
Category
Treatment - Drugs
5
Description
Intervention group 5 (Gluma and laser): The Gluma will be used similar to that used in group 4 on the teeth surface. then, the laser will be exposed with the same radiant profile of the group 1 on its surface.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamadan University of Medical Sciences
Full name of responsible person
Mahsa Forouzande
Street address
Shahid Fahmide
City
Hamadan
Province
Hamadan
Postal code
6516647447
Phone
+98 81 3838 0717
Email
mahsaforouzande@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Loghman Rezaei Soufi
Street address
Shahid Fahmide
City
Hamadan
Province
Hamadan
Postal code
6516647447
Phone
+98 81 3838 0717
Email
loghmansoufi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Mahsa Forouzande
Position
dentistry resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Shahid Fahmide
City
Hamadan
Province
Hamadan
Postal code
6516647447
Phone
+98 81 3838 6410
Email
mahsaforouzande@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Loghman Rezaie Soufi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shahid Fahmide
City
Hamadan
Province
Hamadan
Postal code
6516647447
Phone
+98 81 3838 6410
Email
loghmansoufi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mahsa Forouzande
Position
dentisrty resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Shahid Fahmide
City
Hamadan
Province
Hamadan
Postal code
6516647447
Phone
+98 81 3838 6410
Email
mahsaforouzande@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