Alveolar Ridge Augmentation Clinical Trial
Official title:
Radiographic Evaluation of Low Level Laser Therapy Enhanced Maxillary Sinus Augmentation With Simultaneous Implant Placement
Verified date | June 2017 |
Source | Bulent Ecevit University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This randomized controlled split-mouth clinical trial study was designed to evaluate the
effects of low-level laser therapy on bone healing in patients with bilateral sinus lifting
and simultaneous dental implant application.
Maxillary posterior partially edentulous or totally edentulous twelve patients who need
bilateral sinus bone augmentation were included in this study. Sinus bone augmentation and
dental implant surgeries were done simultaneously. Low level laser therapy (LLLT) was (λ=
630-660 nm, 25 mw / cm², 6 mins) applied for just one operation side at first, third, fifth
and seventh days. Treatment side were randomly selected by another surgeon who applied LLLT.
Panoramic radiographs were taken at the first, third and sixth months using aluminum
step-wedge technique. Optic Density analyses were performed using Cardinal Health Digital
Densitometer (Fluke Biomedical 07-443) with 1mm diameter. Digital densitometric results were
obtained as equivalent aluminum thickness for each radiograph. These data were used to
evaluate changes in optical bone densitometry and compare the LLLT applied side and control
side for each patient.
Status | Completed |
Enrollment | 12 |
Est. completion date | July 2013 |
Est. primary completion date | April 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: Twelve patients were included to this study who required a bilateral sinus floor augmentation for implant-prosthetic rehabilitation. Nine patients were bilaterally free-end partial edentulous and three patients were totally edentulous with residual alveolar height between 3-6 mm. All patients required bilateral sinus augmentation with simultaneous implant placement. Exclusion Criteria: Patients who have maxillary sinus pathology, previous history of chronic sinus infection, smoking more than ten cigarettes per day, any systemic disease interfere with the surgical procedure were excluded from study. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Ugur GULSEN |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bone density analysis | Panoramic radiographs were taken using with aluminum step-wedge technique. These images were used to evaluate changes in optical bone densitometry. | Change from Baseline in Bone Density at 6 months |
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