Determining the effect low power lasers on improving the donor and recipient sites of soft tissue grafts
Design
With a control group, with parallel groups, two-way blind, randomized, on 20 patients, "Software Allocation Random" computer software was used for randomization.
Settings and conduct
Patients who are candidates for donating and receiving soft tissue after harvesting from the palate and transplantation to the relevant site will be divided into two groups. The first group only receives supportive measures such as painkillers and mouthwashes after surgery and the second group uses low-level laser irradiation in addition to supporting measures. After 1, 2, 3 and 4 weeks, the results of changes and recovery process will be recorded and compared by the VAS (Visual Analog Scale for Pain) the amount of housing used and the use of hydrogen peroxide for the diagnosis of epithelial completion will be recorded and compared. The place of study will be Mashhad Faculty of Dentistry.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients referred to periodontics department of Mashhad Faculty of Dentistry
Patients needing a transplant
Patients willing to do laser
Exclusion criteria: Taking certain drugs
Having a specific disease
Intervention groups
The first group received only supportive measures such as painkillers and mouthwashes after surgery and the second group used low-level laser irradiation in addition to supportive measures.
Main outcome variables
Reduce pain, bleeding and recovery time of soft tissue transplantation.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231213060351N1
Registration date:2024-06-22, 1403/04/02
Registration timing:prospective
Last update:2024-06-22, 1403/04/02
Update count:0
Registration date
2024-06-22, 1403/04/02
Registrant information
Name
Alireza Ekhlasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3892 2013
Email address
miralireza.ekhlasi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-30, 1403/04/10
Expected recruitment end date
2024-07-31, 1403/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of low power lasers on improving the donor and recipient sites of soft tissue grafts
Public title
Investigating the effect of low power lasers on soft tissue transplantation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients Referred to Periodontics Ward of Mashhad Dental School
Patients need soft tissue transplantation
Patients willing to do laser
People who don't take any specific medications.
People who don't have a specific disease
Exclusion criteria:
Patients who do not want to have laser
Patients with systemic diseases
Patients taking specific drugs
Patients using drugs
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
20
More than 1 sample in each individual
Number of samples in each individual:
2
Soft tissue graft donor site - Recipient location of soft tissue graft
Randomization (investigator's opinion)
Randomized
Randomization description
Finite randomization and block randomization methods will be used in this study. Random block units will usually be used to balance the number of samples allocated to each of the studied groups. The size of the blocks will be randomly selected and in each block there will be equal number of groups in it.
Blinding (investigator's opinion)
Double blinded
Blinding description
The method of creating random sequences with computer software will be "Software Allocation Random".Random allocation masking will be done using opaque sealed envelopes with random sequence by an independent person who does not know the study process.
In this study, the patient and the statistical analyzer will not know about the study groups. In the case of patients، blinding is that patients do not know that the light being emitted is a low-level laser or that they receive a laser. The data analyst will be blind and all data will be encoded.
Placebo
Not 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
Faculty of Dentistry, Vakilabad Blvd, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Approval date
2024-05-11, 1403/02/22
Ethics committee reference number
IR.MUMS.REC.1403.091
Health conditions studied
1
Description of health condition studied
Soft tissue transplant surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Amount of pain
Timepoint
On the days of surgery and 1, 3 and 5 days after surgery
Method of measurement
Visual Analogue Scale questionnaire
2
Description
Redness or pinkness of the tissue
Timepoint
1, 2, 3 and 4 weeks after surgery
Method of measurement
Photography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After surgery, using a low-power diode laser with a wavelength of 805 to 1064 nm 3 times a week and in a back-and-forth manner on the donor and recipient sites of the soft tissue graft in several points of the soft tissue around the implant (in contact with the tissue surface) will be treated.
Category
Treatment - Devices
2
Description
Control group: This group will have all the same steps as the treatment group, with the difference that a placebo laser (light) will be used.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry of Mashhad
Full name of responsible person
Naser Sargolzaie
Street address
Faculty of Dentistry, Vakilabad Blvd, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3806 7241
Fax
+98 51 3882 9500
Email
SargolzaieN@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
Research and Technology Vice-Chancellor, Qurashi Building, next to Hoveyzeh Cinema, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
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
Alireza Ekhlasi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, Vakilabad Blvd, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3892 2013
Fax
Email
miralireza.ekhlasi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Alireza Ekhlasi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, Vakilabad Blvd, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3892 2013
Fax
Email
Miralireza.ekhlasi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Alireza Ekhlasi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, Vakilabad Blvd, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3892 2013
Fax
Email
Miralireza.ekhlasi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
3 months after publication
To whom data/document is available
Researchers working in academic and scientific institutions and people who are also engaged in industry
Under which criteria data/document could be used
Using the implementation method and results with reference to the source
From where data/document is obtainable
Applicants can get the necessary information by referring to the website of the central library of the university at the address https://centlib.mums.ac.ir/.
What processes are involved for a request to access data/document
An applicant must first send an e-mail to the administrator of the application plan. After checking, the documents will be provided to him within a maximum period of one month.