In this study the effect of nanobiogloss with the help of diode laser will be investigated to determine whether the therapeutic protocol with the help of this laser can have the greatest effect on reducing sensitivity.
Design
A randomized controlled clinical trial with parallel groups non-blind randomization on 15 patients was used for randomization of Excel software.
Settings and conduct
The test is done in Hamedan Dental School of Medical Sciences in the laser department. The degree of sensitivity of teeth to evaporative stimuli before and after treatment will be quantified by airflow at 35 psi.The tooth was dried and isolated, and a cold air flow was injected into the tooth from a distance of one centimeter for 1 second and the tooth response to this stimulus was recorded through the visual analog scale (VAS).
Participants/Inclusion and exclusion criteria
Inclusion criteria are:No known allergy to commercial dental products/There is no residue or residue/No treatment received/No history of receiving teeth whitening treatments.
Intervention groups
Control group: No laser or nanobio-glass applied on dentin surfaces of teeth.
NB group: the solution was applied to the dentin surfaces of the teeth using an applicator brush for 20 seconds in two steps. Group L (laser): Diode laser with special radiation characteristics, scanning in occlusopic and mesiodistal directions dentin surfaces of teeth.nBL group:The surfaces of the teeth were first prepared similar to the nB group, and then they were treated with lasers similar to group L.LnB group: Diode lasers were applied on the surfaces of teeth similar to group L and then similar to nB group Nanobioglus was applied.
Main outcome variables
Decreased dental sensitivity after treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240109060667N1
Registration date:2024-02-05, 1402/11/16
Registration timing:registered_while_recruiting
Last update:2024-02-05, 1402/11/16
Update count:0
Registration date
2024-02-05, 1402/11/16
Registrant information
Name
zahra khalafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 917 758 5429
Email address
sahel21975@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-10, 1402/10/20
Expected recruitment end date
2024-07-10, 1403/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of nano bioglass and diode laser (980 nm) in dentin hypersensitivity treatment: a 6‐month clinical trial
Public title
Evalution the effect of nanobioglass and diode laser (980 nm) in dentin hypersensitivity treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Good general health No known allergy to commercial dental products
Teeth studied have no decay or repair
The patient has not previously received treatment for their dentinal allergy.
The patient should be able to determine the pain score in VAS in terms of age and mentality.
Patients should not have a history of receiving bleaching treatments by bleaching method.
Exclusion criteria:
People with chronic diseases with episodes of daily pain who have taken anticonvulsants، analgesics ، antihistamines ، sedatives ، anti-inflammatory or analgesic drugs in the past 72 hours.
People who have used toothpaste or hypoallergenic mouthwashes in the past 3 months.
People who have had periodontal surgery in the past 6 months.
White bread teeth or white teeth that have cracks, previous repairs, caries lesions or active periodontal disease. Subjects with periodontal recession will remain active in the study.
People with deep cavities in the vicinity of sensitive teeth are likely to be mistaken for sensitive tooth pain.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
15
More than 1 sample in each individual
Number of samples in each individual:
10
The number of sensitive teeth in each person is at least 5-10
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamedan University of Medical Sciences
Street address
Hamedan University of Medical Sciences, Shahid Fahmideh Blvd., Pajoohesh Sq., Hamedan, Iran
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Approval date
2023-11-25, 1402/09/04
Ethics committee reference number
IR.UMSHA.REC.1402.555
Health conditions studied
1
Description of health condition studied
dentin hypersensivity
ICD-10 code
K03.89
ICD-10 code description
Other specified diseases of hard tissues of teeth
Primary outcomes
1
Description
People whose VAS scores are above 5.
Timepoint
Patients were called for followup after 1 week, 1 month and 6 months after treatment. At each visit, the mentioned evaluation process was repeated for each patient and VAS score was recorded.
Method of measurement
The lowest score is zero which means the situation is completely painless, and the highest score is 10, which means the maximum amount of pain that a person can experience.
Secondary outcomes
empty
Intervention groups
1
Description
Control group: No laser or nanobio-glass were applied on dentin surfaces.
Category
N/A
2
Description
NB group (Nanobioglus): 50% solution of biogas nanoparticles and distilled water was prepared. Then, the ultrasonic probe with 20 kHz characteristics was homogenized for 20 seconds and 20 cycles of solution. Then, the solution was applied to dentin surfaces of teeth using an applicator brush for 20 seconds in two steps.
Category
Treatment - Drugs
3
Description
Intervention group: Group L (laser): Diode laser with special radiation characteristics (wavelength 980 nm, power 3 watts, SSP mode, 5 mm non-contact), scanning in occlusopic and mesiodistal directions and vice versa with total radiation time of 21 min/cm2 on dentin surfaces of teeth.
Category
Treatment - Other
4
Description
Intervention group: Intervention group: nBL group (Nanobioglos + laser): The surfaces of the teeth were first prepared similar to the nB group and then they were applied to the same laser as group L.
Category
Treatment - Other
5
Description
Intervention group: Intervention group: LnB group (laser+nanobioglus): Diode liers were applied on the surfaces of teeth similar to group L and then similar to nB group Nanobioglus was applied.