A clinical trial to compare the effectiveness of therapy with low-level laser and Er,Cr:YSGG laser for decreasing the dentinal hypersensitivity after periodontal surgery
The effectiveness of therapy with low-level laser and Er,Cr:YSGG laser for decreasing the dentinal hypersensitivity after periodontal surgery
Design
Totally, 24 candidate patients for periodontal surgery were chosen from Dental Clinic of Mashhad Faculty of Dentistry. In this double-blind, controlled clinical trial, the patients are assigned into parallel groups using random sampling methods.
Settings and conduct
Patients whose undergoing periodontal surgery and referring to the Dental Clinic of Mashhad Faculty of Dentistry, are chosen as the participants of the study. In this double-blind study, the participant and person responsible for data collection are blind to group allocation and the type of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age range of 20-65 years; requiring periodontal surgery in one or more quadrants of the jaw due to the pocket probing depth of more than 5 mm. Exclusion criteria: Having caries lesions or defective restorations; using analgesic or anti-inflammatory drugs; pregnant and breastfeeding women; using anti-allergic drugs in the last 6 months; using anti-sensitive toothpaste in the last 3 months.
Intervention groups
Intervention group I will receive combining both wavelengths of 660 and 810 nm low-level laser. Intervention group II will receive Er,Cr:YSGG laser. Intervention group III will receive fluoride varnish treatment. Control group will receive Placebo laser.
Main outcome variables
To compare the effectiveness of dentin hypersensitivity using cold spray after removal of a periodontal dressing, after laser irradiation, and one week after the intervention.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20091118002736N5
Registration date:2020-11-07, 1399/08/17
Registration timing:prospective
Last update:2020-11-07, 1399/08/17
Update count:0
Registration date
2020-11-07, 1399/08/17
Registrant information
Name
Farzaneh Ahrari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 1883 1145
Email address
ahrarif@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2022-01-21, 1400/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to compare the effectiveness of therapy with low-level laser and Er,Cr:YSGG laser for decreasing the dentinal hypersensitivity after periodontal surgery
Public title
The effectiveness of Laser radiation therapy on dentinal hypersensitivity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range of 20-65 years
Requiring periodontal surgery in one or more quadrants of the jaw due to the pocket probing depth of more than 5 mm
Exclusion criteria:
Having caries lesions or defective restorations
Using analgesic or anti-inflammatory drug
Pregnant and breastfeeding women
Using anti-allergic drugs in the last 6 months
Using anti-sensitive toothpaste in the last 3 months
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
The subjects will be randomly assigned into three groups of 24 patients with categories of 2, 4, 6 and 8 using the randomization method. A noninvolved researcher will determine the random assignment sequencing in sampling using a statistical analysis system (SAS), computer software. Sealed opaque envelopes will be used to conceal the sequencing. Accordingly, the participants were given codes and assigned into the four intervention and control groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients whose undergoing periodontal surgery and referring to Dental Clinic of Mashhad Faculty of Dentistry, are chosen as the participants of the study. In this double-blind study, the participant and person responsible for data collection are blind to group allocation and the type of intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Dental Clinic of Mashhad Faculty of Dentistry, Opposite Mellat Park, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177873476
Approval date
2019-04-22, 1398/02/02
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1398.022
Health conditions studied
1
Description of health condition studied
Dentin hypersensitivity
ICD-10 code
K08.8
ICD-10 code description
Other specified disorders of teeth and supporting structures
Primary outcomes
1
Description
Dentin hypersensitivity using cold spray
Timepoint
After removal of a periodontal dressing, after laser irradiation, and one week after intervention
Method of measurement
Based on visual analogue scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group I will receive combining both wavelengths of 660 and 810 nm low-level laser.
Category
Treatment - Other
2
Description
Intervention group II will receive Er,Cr:YSGG laser.
Category
Treatment - Other
3
Description
Intervention group III will receive fluoride varnish treatment.
Category
Treatment - Other
4
Description
Control group will receive Placebo laser.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad Faculty of Dentistry Dental Clinic
Full name of responsible person
Amir Moeintaghavi
Street address
Dental Clinic of Mashhad Faculty of Dentistry, Opposite Mellat Park, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177873476
Phone
+98 51 3882 9504
Email
moeentaghavia@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177873477
Phone
+98 51 3841 2081
Email
tafaghodim@mums.ac.ir
Grant name
941408
Grant code / Reference number
941408
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Farzaneh Ahrari
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental Clinic of Mashhad Faculty of Dentistry, Opposite Mellat Park, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177873476
Phone
+98 51 3882 9504
Email
Ahrarif@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farzaneh Ahrari
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental Clinic of Mashhad Faculty of Dentistry, Opposite Mellat Park, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177873476
Phone
+98 51 3882 9504
Email
Ahrarif@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farzaneh Ahrari
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental Clinic of Mashhad Faculty of Dentistry, Opposite Mellat Park, Vakilabad Blvd
City
mashhad
Province
Razavi Khorasan
Postal code
9177873476
Phone
+98 51 3882 9504
Email
Ahrarif@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The data of the patients are not allowed to be shared.
Study Protocol
No - There is not 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