Effect of Low Level Laser Teraphy on Bone Regeneration

NCT03179683 | Completed

• 1 other identifier: 824-02/9-8/97
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Alveolar Ridge Augmentation

Keywords

aluminum step-wedge; demineralized bone matrix; dental implant; digital densitometry; low level laser therapy; maxillary sinus augmentation.

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Diode laser application

ACTIVE COMPARATOR

An 630-660 nm aluminum gallium indium phosphide (AlGalnP) laser device (Scorpion Dental Optima Model 405-7A; Optica Laser, Sofia, Bulgaria) was used immediately after surgery, third day, fifth day and seventh day only for one operation side (treatment group)

Device: Diode laser application

No application

NO INTERVENTION

no treatment were aplied

Interventions

Diode laser application DEVICE

an 630-660 nm aluminum gallium indium phosphide (AlGalnP) laser device (Scorpion Dental Optima Model 405-7A; Optica Laser, Sofia, Bulgaria) was used immediately after surgery, third day, fifth day and seventh day only for one operation side. Treatment side were randomly selected by another surgeon who applied LLLT. Tissue was irradiated at 25mW power for total six minutes, two minutes for each point (buccal, palatal, crestal). 72J /cm2 energy density was deposited in one session.

Diode laser application

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ugur GULSEN: lead

Study Officials

• Ugur GULSEN

  Bulent Ecevit University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Model Details: The study was planned as randomized controlled split-mouth clinical study. Bilateral 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 and no treatment were applied to other group(control group)

Study Record Dates

• First Submitted: May 29, 2017
• First Posted: June 7, 2017
• Study Start: October 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: July 1, 2013
• Last Updated: June 7, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share