Evaluation The effect of Light Emitting Diode Photobiomodulation on stability of dental implants in bone grafted cases
Design
Randomized, blinded
Settings and conduct
A total of 8 patients with Double_sided or complete jaw Toothless which are eligible for study are selected from the Clients of the Implant Department of the Faculty and will be given an informed consent in the study after receiving consent. An implant placement surgery on both sides of the patient will be done by an experienced periodontist, and samples will be selected to implant placental tooth extraction with bone agment without advance flap and one-step placement. The patient is randomly selected and will be exposed to LED for 20 minutes on the day before the surgery and 10 consecutive sessions starting from the day of surgery. The trained person who is not aware of the study measures the implant stability quotient by the osstell apparatus on both sides of the patient immediately, one and three months after the operation, and records it in the same person's table.
Participants/Inclusion and exclusion criteria
No smoking
Being healthy systemically
The need for double-sided mandible or maxillary implant treatment that has the same surgical conditions
Bone walls have four walls after tooth extraction
lack of Fenestration and dehiscence
pregnant women
Presence of pathologic signs in the implant site
Systemic diseases such as uncontrolled diabetes-cardiovascular disease-malignancy - head and neck radiotherapy - autoimmune diseases that make it difficult to repair soft and hard tissue.
Patients who can not be placed in the form of one stage implantation and need to be submerge Using steroid medications, immunosuppressant and bisphosphonates
Intervention groups
one side of unilateral or bilateral partial edentulous patient after implant placement surgery with Photobiomodulation
Main outcome variables
implant stability quotient
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20121216011770N5
Registration date:2019-05-08, 1398/02/18
Registration timing:registered_while_recruiting
Last update:2019-05-08, 1398/02/18
Update count:0
Registration date
2019-05-08, 1398/02/18
Registrant information
Name
Atabak Kashefimehr
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 5965
Email address
kashefimehra@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-09, 1397/11/20
Expected recruitment end date
2019-05-10, 1398/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Light Emitting Diode Photobiomodulation on stability of dental implants in bone grafted cases
Public title
The effect of LED Photobiomodulation on stability of dental implants in bone grafted cases
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
No smoking
Being healthy systemically
The need for double-sided mandible or maxillary implant treatment that has the same surgical conditions
Bone walls have four walls after tooth extraction
lack of Fenestration and dehiscence
Exclusion criteria:
pregnant women
Presence of pathologic signs in the implant site
Systemic diseases such as uncontrolled diabetes - cardiovascular disease - malignancy - head and neck radiotherapy - autoimmune diseases that make it difficult to repair soft and hard tissue.
Patients who can not be placed in the form of one stage implantation and need to be submerge
Using steroid medications, immunosuppressant and bisphosphonates
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
12
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences Ethics Committee
Street address
Tabriz University of Medical Sciences, Daneshgah St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2019-02-03, 1397/11/14
Ethics committee reference number
IR.TBZMED.REC.1397.910
Health conditions studied
1
Description of health condition studied
Toothless
ICD-10 code
K08.1
ICD-10 code description
Complete loss of teeth
Primary outcomes
1
Description
Implant stability quotient
Timepoint
One and three months after surgery
Method of measurement
osstell device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: one side of unilateral or bilateral partial edentulous patient after implant placement surgery with Photobiomodulation
Category
Treatment - Surgery
2
Description
Control group: one side of unilateral or bilateral partial edentulous patient after implant placement surgery without Photobiomodulation
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Dental Faculty, Department of Periodontics
Full name of responsible person
Dr. Atabak Kashefimehr
Street address
Golgasht Street,Tabriz Dental Faculty
City
Tabriz
Province
East Azarbaijan
Postal code
5619941213
Phone
+98 41 3335 5969
Email
kashefimehra@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Reza Pourabbas
Street address
Tabriz Dental Faculty, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
Email
Kashefimehra@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Atabak Kashefimehr
Position
Periodontist, Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tabriz Dental Faculty, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 1335 5965
Fax
+98 41 1334 6977
Email
Kashefimehra@tbzmed.ac.ir
Web page address
http://dentistryfac.tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Atabak Kashefimehr
Position
Periodontist, Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tabriz Dental Faculty, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 1335 5965
Fax
+98 41 1334 6977
Email
Kashefimehra@tbzmed.ac.ir
Web page address
http://dentistryfac.tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Atabak Kashefimehr
Position
Periodontist, Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tabriz Dental Faculty, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 1335 5965
Fax
+98 41 1334 6977
Email
Kashefimehra@tbzmed.ac.ir
Web page address
http://dentistryfac.tbzmed.ac.ir
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
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data has subscription capability
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
All people
Under which criteria data/document could be used
No specific case
From where data/document is obtainable
Email Dr. Kashfi Mehr
What processes are involved for a request to access data/document