Photobiomodulation and Implant Stability

Study Overview
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Brief Summary
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Objective: The aim of the present study was to address the following questions: does photobiomodulation therapy (PBMT) improve implant stability and affect microbiota around dental implants in the early stage of osseointegration. Material and Methods: Implants will randomly be divided into two groups and implants will be placed in the test group treating with Gallium-aluminum-arsenate (GaA1As) diode laser with photobiomodulation therapy immediately after surgery and for 15 days. In the control group, implants are not irradiated. The primary stability of the implants will measure by the Resonance frequency analysis (RFA) after insertion and the secondary stability values will record at 30th, 60th, and 90th days after surgery as implant stability quotient (ISQ). Plaque samples will collect for microbiological analyzes at the first 24 hours after implant surgery and six days after 90 days at six sterile endodontic paper points.

Detailed Description
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The same surgical procedure will be operated in the test and control groups by the same surgeon. Full-thickness flaps were raised and dental implant osteotomy preparation will be completed according to the manufacturers' instructions. Laser treatment will be completed using Gallium-Aluminum-Arsenide diode laser. The photobiomodulation application will v-be completed by laser energy immediately and three times a week for just 15 days after surgery. The control group will consist of laser application without energy delivery to the tissue. Immediately after implant placement, the third generation stability resonance frequency (RF) analyzer will be applied for direct measurement of implant stability and the value will be recorded. The microbiological plaque samples will be collected at specific times, according to the following schedule; at the first 24-hour and 90 days after implant surgery. All bacterial DNA specimen will be analyzed with qPCR technique to evaluate Aggregatibacter actinomycetemcomitans (Aa), Porphyromonas gingivalis (Pg), Prevotella intermedia (Pi) , Tannerella forsythia (Tf ) and total amount of bacteria.

Official Title
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The Effect of Photobiomodulation Application on Implant Stabilization and Peri-implant Microbiology

Conditions
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Photobiomodulation Therapy

Intervention / Treatment
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* Device: photobiomodulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: at least one tooth loss in left and right posterior sides of upper and lower jaws adequate alveolar bone volume as horizontal and vertical Exclusion Criteria: uncontrolled systemic diseases parafunctional (bruxism and/or clenching) smoking habits any allergies or metabolic bone diseases, pregnancy surgical periodontal treatment in 6 months using antibiotics in the last 6 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Implants were randomly divided into two groups and implants placed in the test group were treated with Gallium-aluminum-arsenate (GaA1As) diode laser with photobiomodulation therapy immediately after surgery and for 15 days. In the control group, implants were not irradiated.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Group (TG)<br>The study included test group with Photobiomodulation treatment after dental implant surgery | Device: photobiomodulation<br>* Laser treatment will complete using Gallium-Aluminum-Arsenide (GaA1As) diode laser and application will complete by laser energy immediately and three times a week for just 15 days after surgery.<br>* Other names: low-level laser therapy;|
| Active Comparator: Control Group (CG)<br>The control group consisted of laser application without energy delivery to the tissue. | Device: photobiomodulation<br>* Laser treatment will complete using Gallium-Aluminum-Arsenide (GaA1As) diode laser and application will complete by laser energy immediately and three times a week for just 15 days after surgery.<br>* Other names: low-level laser therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| primary and secondary implant stability | Immediately after implant placement, the third generation stability resonance frequency (RF) analyzer (Osstell ISQ, Integration Diagnostics AB, Gamlestadsvägen, Goteborg, Sweden) was applied for direct measurement of implant stability and the value was recorded. | The stability was measured at immediately postoperatively. | 
| primary and secondary implant stability | Immediately after implant placement, the third generation stability resonance frequency (RF) analyzer (Osstell ISQ, Integration Diagnostics AB, Gamlestadsvägen, Goteborg, Sweden) was applied for direct measurement of implant stability and the value was recorded. | The stability was measured at 30 days postoperatively. | 
| primary and secondary implant stability | Immediately after implant placement, the third generation stability resonance frequency (RF) analyzer (Osstell ISQ, Integration Diagnostics AB, Gamlestadsvägen, Goteborg, Sweden) was applied for direct measurement of implant stability and the value was recorded. | The stability was measured at 60 days postoperatively. | 
| primary and secondary implant stability | Immediately after implant placement, the third generation stability resonance frequency (RF) analyzer (Osstell ISQ, Integration Diagnostics AB, Gamlestadsvägen, Goteborg, Sweden) was applied for direct measurement of implant stability and the value was recorded. | The stability was measured at 90 days postoperatively. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the number of peri-implant total microorganisms by PCR | The sample of the dental implant to be sampled is gently isolated with sterile cotton rolls. Then standardized sterile endodontic paper-points with tip size 40 were inserted into crevice very gently avoiding gingival bleeding. The paper-points were immediately put into sterilized Eppendorf tubes. | Microbiological samples will obtained at the first 24-hour after implant surgery | 
| Evaluation of the number of peri-implant total microorganisms by PCR | The sample of the dental implant to be sampled is gently isolated with sterile cotton rolls. Then standardized sterile endodontic paper-points with tip size 40 were inserted into crevice very gently avoiding gingival bleeding. The paper-points were immediately put into sterilized Eppendorf tubes. | Microbiological samples will obtained at the 90 days after implant surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low-level laser therapy implants