1. Home
  2. Approved trials
  3. » فارسی

Evaluation of Effect of Light Emitting Diode ( LED) on the َAllograft Bone after the Open Sinus Lift ( A Randomized clinical trial study)

Protocol summary

Study aim
Light Emitting Diode (LED) phototherapy has been used in some medical specialties because of its probable bio-stimulatory effect on biological tissues. However, Low Level Laser Therapy (LLLT) and LED phototherapy applications are still place of controversies because of different results in literature. Just a few studies have worked on the effect of phototherapy on bone stimulation clinically. So, the aim of this in vivo study was histological evaluation of quantity and maturational quality of the newly formed bone in the human maxillary sinuses after LED phototherapy.
Design
After 6 months, the sinus graft sites were re-opened to insertion of dental implants and bony biopsies were taken simultaneously. The specimens were routinely processed and colored with Hematoxylin and Eosin staining (H & E) and assessed by light microscope consequently.
Settings and conduct
The study is double blind. The samples were randomly divided into two groups by coin.
Participants/Inclusion and exclusion criteria
Exclusion criteria consist of smokers, having chronic sinusitis, diabetes, history of cancers and Bisphosphonate consumption and not willing to use LED device. Inclusion criteria do not include patients with chronic sinus disease, chronic bone disease, have no history of surgery. Do not have diabetes. Informed consent form of the company to sign the research.
Intervention groups
Forty patients were randomly divided into 2 groups (n=20). Group A received LED phototherapy (Biolux Ltd, Vancover, Canada) with continuous wave length of 620 nm, 20 min/day for 21 days, after sinus lifting procedure. Group B was chosen as non-radiated controls.
Main outcome variables
Use of LED after surgery, bone maturity, osteoporosis, inflammation rate

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180222038827N1
Registration date: 2018-03-10, 1396/12/19
Registration timing: retrospective

Last update: 2018-03-10, 1396/12/19
Update count: 0
Registration date
2018-03-10, 1396/12/19
Registrant information
Name
Mahnaz Arshad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2227 3471
Email address
Arshad-m@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Effect of Light Emitting Diode ( LED) on the َAllograft Bone after the Open Sinus Lift ( A Randomized clinical trial study)
Public title
Evaluation of Effect of Light Emitting Diode ( LED) on the َAllograft Bone after the Open Sinus Lift ( A Randomized clinical trial study)
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Have no chronic sinus disease There is no chronic bone marrow disease There is no history of surgery in the area Do not have diabetes Knowingly sign the consent form of the company in the research. Have no history of radiotherapy and chemotherapy Maxillary premolars edentoulism
Exclusion criteria:
Smoking Chronic sinus disease Diabets History of cancer Consumption ofBisphosphonates Failure to use LED device
Age
From 20 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Care provider
  • Data analyser
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly assigned to a number ranging from 1 to 40. The number of individuals in the case and paired numbers were in the control group, each group containing 20 patients
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the pathologist examines the histology of the specimens and the surgeries that have undergone the surgical procedure and the sampling have been kept blind.
Placebo
Not used
Assignment
Parallel
Other design features
none

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Unit 9, 3th Floor, Number 3, first Alley, Sanjabi Street, Madar Square, Mirdamad Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
19119-33963
Approval date
2018-02-24, 1396/12/05
Ethics committee reference number
IR.TUMS.REC.1394.1181

Health conditions studied

1

Description of health condition studied
edentoulism
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Maxillary premolar missing
Timepoint
Group A received LED phototherapy (Biolux Ltd, Vancover, Canada) with continuous wave length of 620 nm, 20 min/day for 21 days, after sinus lifting procedure. After 6 months, the sinus graft sites were re-opened to insertion of dental implants and bony biopsies were taken simultaneously.
Method of measurement
A blind examiner (maxillofacial pathologist) analyzed each sample with a light microscope. In histological evaluations of these cases, following items were examined and graded as mentioned below:Degree of inflammation: defined as the following numbers: 1 = absence of inflammation, 2 = moderate inflammation and 3 = severe inflammation. Formation and bone quality: defined as the following numbers: 1 = connective tissue containing blood vessels, fibroblasts, macrophages, collagen fibers, 2 = dense connective tissue with the presence of large number of cells that differentiate into bone tissue which represents the initiation of bone formation, 3 = formation of new bone tissue, dense connective tissue, 4 = obvious bony tissues. The density of collagen fibers (maturation): it defined as the following numbers: 1 = absence of collagen fibers, 2 = average density of collagen fibers, 3 = high density of collagen fibers without a regular structure (assessed by using polarized light), 4 = extreme density of collagen fibers with a definite structure (assessed by using polarized light) based on a pathologist's judgment after viewing all the samples at ×100 magnification.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Sinus Lifting and LED
Category
Treatment - Devices

2

Description
Control group: Sinus lifting
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
dental implant Center, Tehran University of Medical Sciences
Full name of responsible person
Mahnaz Arshad
Street address
Unit 9, 3th Floor, Number 3, first Alley, Sanjabi Street, Madar Square, Mirdamad Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
19119-33963
Phone
+98 21 2227 3471
Fax
+98 21 2640 5264
Email
mahnazarshad@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Gholamreza Shirani
Street address
North Amir Abad, not reaching Hakim exit, Tehran Faculty of Dentistry, Dental Implant Center
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8835 1178
Email
ghr.shirani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mahnaz Arshad
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Unit 9, 3th Floor, Number 3, first Alley, Sanjabi Street, Madar Square, Mirdamad Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
19119-33963
Phone
+98 21 2227 3471
Email
Arshad-m@tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahnaz Arshad
Position
Assistant professor
Latest degree
Master
Other areas of specialty/work
Dentistry
Street address
Unit 9, 3th Floor, Number 3, first Alley, Sanjabi Street, Madar Square, Mirdamad Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
19119-33963
Phone
+98 21 2227 3471
Email
mahnazarshad@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahnaz Arshad
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Dentistry
Street address
Unit 9, 3th Floor, Number 3, first Alley, Sanjabi Street, Madar Square, Mirdamad Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
19119-33963
Phone
+98 21 2227 3471
Email
mahnazarshad@yahoo.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
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
starting 6 months after publication
To whom data/document is available
all peaple
Under which criteria data/document could be used
none
From where data/document is obtainable
email to dr. Arshad
What processes are involved for a request to access data/document
none
Comments
Loading...