Evaluation of the effect of using low level laser therapy in management of the complications of guided bone regeneration(GBR) surgeries in patients who need this surgery
Determining the effect of low-level laser therapy as a post operative treatment in management of the complications of guided bone regeneration (GBR) surgeries .
Design
Clinical trial with a control group, with parallel groups, triple blinded, randomized, phase 3 on 22 patients. Computer random numbers are used for randomization
Settings and conduct
A clinic in the city of Ahvaz for referring patients
After surgery, low-level laser therapy is performed and examinations related to the study are performed
It is ensured that patients participate in the study with informed consent.
Patients are blinded: they do not know whether the laser device is on or off
clinical examiner is blinded: they are not aware of the group of each patient
data analyst or statistical consultant is blinded: they will analyze the data of each group without knowing which group is the control and which is the intervention.
Participants/Inclusion and exclusion criteria
Patients beneath 60 years old who are medically healthy and in need of GBR surgery and not having photosensitivity
Intervention groups
For the intervention group, for each patient, the surgical site will be irradiated with a diode laser with a wavelength of 940 nm and a power of 300 mW and 16 seconds for each cm2 of the lesion, immediately after the end of surgery and 48 hours after the surgery. (The required dose for laser therapy is 5 j/〖cm〗^2, there is 16 seconds of radiation needed for each cm2).
In the control group, laser irradiation is performed with the device turned off at the same time as the intervention group
Main outcome variables
severity of pain
The degree of inflammation
Wound healing
Homeostasis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221023056272N1
Registration date:2023-04-29, 1402/02/09
Registration timing:registered_while_recruiting
Last update:2023-04-29, 1402/02/09
Update count:0
Registration date
2023-04-29, 1402/02/09
Registrant information
Name
Asma Moghadasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 933 177 4942
Email address
moghadasi.a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-21, 1402/02/01
Expected recruitment end date
2023-05-22, 1402/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of using low level laser therapy in management of the complications of guided bone regeneration(GBR) surgeries in patients who need this surgery
Public title
Evaluation the effect of low level laser therapy in management of the complications after guided bone regeneration(GBR) surgeries.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients must be medically healthy
Having healthy oral mucosa.
Not having the history of implant failure at the surgical site or contraindications for implant placement
Patients must be in need of bone grafting for placement of implant
Cases, with maximum 0.5cc bone powder required for bone grafting, are going to be chosen
The surgical field should be limited to 1 to 3 teeth
Patients should not use removable prosthesis or similar items
No history of medical conditions that might delay wound healing process such as: diabetes, smoking, and alcohol consumption.
Exclusion criteria:
Lack of Patient's cooperation
Having photosensitivity
Patients who have used antibiotics and corticosteroids for any reason in the last 2 weeks
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
22
Randomization (investigator's opinion)
Randomized
Randomization description
A list of 22 characters consisting of 11 characters A (representative of the laser radiation group) and 11 characters B (representative of the group without laser radiation (placebo)) is created by simple randomization using the envelope-in-package method, and the patients are placed in one of groups A or B according to the order of their referral
Blinding (investigator's opinion)
Triple blinded
Blinding description
Participant: For all the people participating in the study, the laser irradiation process is performed , the difference is that for the intervention group, the laser irradiation process is performed with the laser on, and for the control or placebo group, the laser irradiation process is performed with the laser off.
Outcome assessor (clinical examiner): the clinical examiner does the patient's examination without being aware of the patient's group and records the necessary information.
Data analyst: The data analyst or statistical consultant will analyze the data of each group without knowing witch group is the control and which is the intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahwaz University of Medical Sciences
Street address
4th Floor ,No.12, Elham sharghi Street. Kianpars Street
City
Ahwaz
Province
Khouzestan
Postal code
6155843651
Approval date
2023-04-08, 1402/01/19
Ethics committee reference number
IR.AJUMS.REC.1402.014
Health conditions studied
1
Description of health condition studied
Post-operative complications of guided bone regeneration
ICD-10 code
T88.8XXA
ICD-10 code description
Other specified complications of surgical and medical care, not elsewhere classified, initial encounter
Primary outcomes
1
Description
The VAS(visual analog scale) number of pain intensity declared by patients
Timepoint
At 12, 24, 48, 72 hours after surgery
Method of measurement
based on VAS (visual analog scale)
2
Description
The assigned number of the hemostasis status
Timepoint
On second day after surgery
Method of measurement
The number assigned to each hemostasis status is based on the following classification: 0 for the presence of bleeding in the wound margin/1 for the presence of fibrin in the wound margin/2 for the absence of fibrin in the wound margin.
3
Description
Determining the degree of wound healing based on assigned numbers
Timepoint
On the seventh day after surgery
Method of measurement
Wound healing is graded as follows: 0 for complete wound healing / 1 for wound healing and the presence of a thin line of fibrinous membrane / 2 for wound healing and the presence of fibrin / 3 for incomplete wound closure and the presence of a gap/ 4 no wound healing (necrosis)
4
Description
Determining the degree of inflammation based on two factors: 1) the degree of redness of the wound margin 2) presence or absence of extraoral swelling
Timepoint
On the second and seventh day after surgery
Method of measurement
To check the redness of the wound margin, the following grading is used: 0 for redness over 50% of the length of the wound margin / 1 for redness less than 50% of the length of the wound margin / 2 no redness
Secondary outcomes
1
Description
The number and dose of painkillers taken by the patient
Timepoint
On seventh day after surgery
Method of measurement
After the surgery, the patient is given a table and asked to make notes in the table after receiving each painkiller. And the table is delivered on the seventh day
Intervention groups
1
Description
Intervention group: Laser radiation: In the laser radiation group, immediately after the surgery for each patient, the surgical site will be irradiated with Diode laser with a wavelength of 940 nm and a power of 300 mW and 16 seconds for each cm2 of the lesion. The necessary dose for laser therapy is 5 j/〖cm〗^2 (we will have 16 seconds of radiation for each cm2). According to the explained method, the same amount of energy is again irradiated to the desired area 48 hours after the surgery.
Category
Treatment - Devices
2
Description
Control group: In the control group, laser irradiation is performed with the device turned off at the same time as the intervention group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Arad dental clinic
Full name of responsible person
Dr. Ebrahim Moghadasi
Street address
No. 50, West 3, Kianpars Streat, Ahwas town
City
Ahwaz
Province
Khouzestan
Postal code
6155843651
Phone
+98 61 3338 4393
Email
emog9933@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehrnoosh Zakerhoseini
Street address
Ahvaz Academic City - Vice President of Research and Technology University of Medical Sciences and Jandi Shapur Health Services, Ahvaz - ground floor
City
Ahwaz
Province
Khouzestan
Postal code
6135715775
Phone
+98 61 3336 2414
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Asma Moghadasi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Floor. 2, No. 12, East Elham, Kianpars Street
City
Ahwaz
Province
Khouzestan
Postal code
6155843651
Phone
+98 61 3333 5830
Email
asma.moghadasi98@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Asma Moghadasi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
East elham, kianpars streat, Ahwaz town
City
Ahwaz
Province
Khouzestan
Postal code
6155843651
Phone
+98 933 177 4942
Fax
Email
moghadasi.a@ajums.ac
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Asma Moghadasi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Floor. 2, No. 12, East Elham, Kianpars Street
City
Ahwaz
Province
Khouzestan
Postal code
6155843651
Phone
+98 61 3333 5830
Email
asma.moghadasi98@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