Study the amount of tissue repair in immediate implants by the low power laser radiation (LLLT)
Design
A clinical trial with a control group parallel to the study group; Double blind and randomized on 20 patients. Random Allocation Software is used for randomization.
Settings and conduct
In this clinical trial that will be conducted in the Mashhad Dental School, after obtaining informed consent from eligible patients, the patients will be randomly divided into two groups of low power laser treatment or control. Bone volume and proper bone conditions of the patient will be done with radiographs. In the treatment group, diode laser with a wavelength of 830 nm with a power of 50 mW in three different doses (5, 10 and 20 J/cm2) in three sessions (every other day from the first day of the implant graft) and in several points The soft tissue around the implant will be used (in contact with the surface of the tissue) and placebo laser will be used in the control group after implant implantation. In one week, two weeks, three weeks, four weeks, 8 weeks, 12 weeks and 16 weeks, we will follow up the patients and register the soft tissue changes in two groups. Finally, we will analyze the obtained results.
Participants/Inclusion and exclusion criteria
Sufficient volume of bone؛
Drug use and addiction؛
Having systemic diseases؛
Reluctance to cooperate؛
Absence in examinations
Intervention groups
In the group of treatment with low power laser radiation, from the diode laser with a wavelength of 830 nm with 50 mW
In the control group, a placebo laser is used after implant placement.
Main outcome variables
The speed of tissue healing
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240122060765N1
Registration date:2024-05-21, 1403/03/01
Registration timing:prospective
Last update:2024-05-21, 1403/03/01
Update count:0
Registration date
2024-05-21, 1403/03/01
Registrant information
Name
Mehdi Ebrahimian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3868 6473
Email address
mehdi.ebrahimian98@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-20, 1403/05/30
Expected recruitment end date
2025-03-20, 1403/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of Low-Level laser Therapy (LLLT) on tissue healing in immediate implants
Public title
Evaluation of the effects of Low-Level laser Therapy (LLLT) on tissue healing in immediate implants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient of Dentistry University of Mashhad Implant section
Patient who have adequate bone volume for putting implant
Exclusion criteria:
Use drug and addiction
Use effective drugs on bone osteointegration
Having systemic disease
Patient who doesn't want to
Patient who were absent because they want putting their implant out of university
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
The method of limited randomization and block randomization will be used in this study. Random block units will usually be used in order to balance the number of samples allocated to each of the studied groups. The size of the blocks will be chosen randomly and in each block there is an equal number of each group. The way to make the random sequence is by the computer software "Random Allocation Software". Concealment of random allocation will be done by using opaque sealed and waxed envelopes in a random sequence by an independent person who is not aware of the study process.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding in this study will be done in three stages.
1- Patients: after consenting to participate in the study, blinding occurs in patients without knowing whether the irradiated light is a laser or a laser.
2- Evaluator: In order to blind the evaluator, the evaluation will be done by a student who is not aware of the type of laser beamed to the patient.
3- Data analyst: In order to blind the stage, the data will be provided to the analyst in coded form.
Placebo
Used
Assignment
Crossover
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
2024-03-09, 1402/12/19
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1403.035
Health conditions studied
1
Description of health condition studied
Soft tissue repair around the implant
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Examination of implant stability index
Timepoint
Weeks 1, 2, 3 and 4 will be compared with patients who were not irradiated with laser
Method of measurement
The OSSTELL device will be used to check the implant stability index (Implant Stability Quotient) ISQ
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, using a low-power diode laser with a wavelength of 830 nm and a power of 50 mW in three different doses (5f 10 and 20 J/cm2) in three sessions (every other day from the first day of grafting implant) and in several points of the soft tissue around the implant (in contact with the surface of the tissue) will be treated.
Category
Treatment - Other
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
Mohammad Garayeli
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
mvzynb@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Rasool Sahebalam
Street address
Faculty of Dentistry, Vakilabad Blvd, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3806 7241
Email
mvzynb@gmail.com
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
Mahdi Ebrahimian
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 3806 7241
Email
mehdi.ebrahimian98@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahdi Ebrahimian
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 3806 7241
Email
mehdi.ebrahimian98@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahdi Ebrahimian
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 3806 7241
Email
mehdi.ebrahimian98@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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is 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
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