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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180222038827N1

Enrollment

Registered

2018-03-10

Start date

2017-02-19

Completion date

Unknown

Last updated

2018-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

edentoulism.

Interventions

Intervention 1: Intervention group: Sinus Lifting and LED. Intervention 2: Control group: Sinus lifting.

Eligibility

Sex/Gender

All

Age

20 Years to 80 Years

Inclusion 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

Exclusion criteria: Smoking Chronic sinus disease Diabets History of cancer Consumption ofBisphosphonates Failure to use LED device

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahnaz Arshad

Tehran University of Medical Sciences

Arshad-m@tums.ac.ir+98 21 2227 3471

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026