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Alveolar Ridge AugmentationNCT03179683

Effect of Low Level Laser Teraphy on Bone Regeneration

A study testing Diode laser application in people with Alveolar Ridge Augmentation, run by Ugur GULSEN.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Alveolar Ridge Augmentation
What is being tested?
Diode laser application
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
No sites listed yet
Study dates
Oct 2011to Jul 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

About this study

Official title: Radiographic Evaluation of Low Level Laser Therapy Enhanced Maxillary Sinus Augmentation With Simultaneous Implant Placement

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.

Read the detailed description

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.

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.

The study protocol was conducted by Ankara University Dentistry Faculty Research Ethics Committee. All patients were informed about the treatment procedure and all patients gave written consent for participation.

Surgical Protocol Bilateral sinus augmentation and simultaneous implant placement were performed in one appointment with same surgical protocol. All surgical procedures performed under local anesthesia (Ultracain D-S Forte; Sanofi-Aventis, Istanbul, Turkey). After elevation of mucoperiosteal flap a hinge door osteotomy was performed on the lateral wall of the maxillary sinus with a round diamond bur under saline solution irrigation. Schneiderian membrane was carefully detached from inferior and lateral walls of the sinus until creating enough space for placement of bone grafts. Implant osteotomies were performed and DBM putty bone graft (DynaGraft bone putty, Keystone Dental, Burlington, Mass) were placed medial, posterior and anterior side of implant sockets. Implants (Touareg S, Adin, Afula, Israel) were inserted into the osteotomy site after sufficient grafting. Access window filled with bone graft after implant placement. Membrane was not used over access window. 3/0 silk suture were used for closure of the flap. Antibiotic (amoxicillin thrice per day), analgesic (naproxen sodium, 2 twice per day) and mouthwash (isotonic saline twice per day) were prescribed for postoperative management. The patients were advised to have a soft diet and to avoid sneezing until two weeks. Sutures were removed one-week after surgery. No complications occurred during surgery. All surgical wounds healed uneventfully.

Low Level Laser Therapy Protocol In this study, 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.

Radiological Evaluation Aluminum Step-Wedge and Radiographic Assessment Aluminum step-wedge was used as the reference material in densitometric evaluation of the conventional radiographs. The aluminum wedges were prepared using 99,7% pure aluminum plates, the dimensions of the plates were 1 mm in width and 2, 4, 6, 8, 10, 12 mm in length. Prepared six aluminum plates were sticked in a row and a stair-like aluminum wedge had acquired.

Prepared aluminum step-wedges were located in a fixed place (lower left corner) in the film cassettes in order to maintain the calibration and standardization of the radiographs. Special care was taken to avoid the superposition of the hyoid bone and other bony structures with the step-wedge.

In this research, all radiographic assessments were made using panoramic radiographs. The radiographic assessments were done by the same radiology technician from the Oral Diagnosis and Radiology department of Ankara University. Mediphot X-O/RP, sens: green, 15x30 panoramic radiographs were used in this research.

All radiographs were taken with 80 kVp, 12 mA, 2.5 mm Al total filtrated "PM 2002 CC Proline" panoramic radiography device using the same kV and mA values. Radiographic film processing was made in automatic radiograph processing devices, Velopex and Extra-XE.

Four panoramic radiographs were taken from each patient, which were preoperative and postoperative on first., third and sixth months.

Densitometric Assessment Densitometrical analysis was performed on forty-eight radiographs which were taken preoperatively and on postoperative first, third and sixth. Months in this research. Densitometric assessments of the radiographs were made in Medical Physics department of the Ankara University Nuclear Sciences Institute. Cardinal Health Digital Densitometer (Fluke Biomedical 07-443) with 1 mm diameter used in optic density measurement. Results were read and recorded immediately from the devices screen.

Densitometric measurement was repeated three times in each radiograph and an average was acquired, the used spots were every step of the step-wedge and the augmented sinus areas.

Aluminum equivalent thickness of the augmented sinus areas were identified. With this information, the mineralization levels of the graft materials on the radiographs were identified and acquired results were assessed statistically.

Statistical Assessment The Shapiro-Wilk test was used to determine whether the data were normally distributed. The Friedman test was used for four time points in two groups. In cases of significant differences among measurements, the Bonferroni-adjusted Wilcoxon signed-rank test was used as post hoc analysis. Additionally, the Bonferroni-adjusted Wilcoxon signed-rank test (paired observations) was used to compare the two groups in the same time points. All tests were performed using statistical software (SPSS Inc., version 19.0, Chicago, IL, USA). The median with min-max values were calculated for each parameter as the statistical unit. P < 0.05 was statistically significant.

Being tested
Diode laser application
Keywords
aluminum step-wedge, demineralized bone matrix, dental implant, digital densitometry, low level laser therapy, maxillary sinus augmentation.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diode laser applicationDevice

    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.

Study groups in NCT03179683
Study groupRoleWhat they receive
Diode laser applicationActive comparatorAn 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)
Receives: Device: Diode laser application
No applicationNo interventionno treatment were aplied

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Change from Baseline in Bone Density at 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2017
  2. Study startOct 2011
  3. Primary completionApr 2013
  4. Study completionJul 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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)
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03179683
Sponsor's protocol ID
824-02/9-8/97
Status last verified
Jun 2017
First submitted
29 May 2017
Last updated
7 Jun 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Diode laser application in people with Alveolar Ridge Augmentation, run by Ugur GULSEN.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bone density analysis (time frame: Change from Baseline in Bone Density at 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2017.

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