Photobiomodulation of Orthodontic Mini-implants by a 635nm Diode Laser

Study Overview
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Brief Summary
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The study aimed to estimate clinically an influence of 635nm diode laser on the primary and secondary stability of orthodontic mini-implants placed in a maxilla, to assess mini-implants failure rate (mini-implant loss) and to evaluate a pain level after the treatment. The randomized clinical split-mouth trial included 15 subjects, 30 implants (Dual Top Anchor System, Seoul, Korea) with a diameter 1.4mm and length of 10mm. Mini-implants were placed in the area of the attached gingiva between the second premolar and first molar teeth 2 mm below the mucogingival junction of both sides of the maxilla in 15 patients.

Official Title
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Photobiomodulation of Orthodontic Mini-implants by a 635nm Diode Laser: Primary and Secondary Stability. A Randomized Clinical Split-Mouth Trial.

Conditions
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Malocclusion, Angle Class II

Intervention / Treatment
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* Procedure: Irradiation of implants with 635nm laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with class II malocclusion defect requiring lateral maxillary teeth distillation based on the use of orthodontic mini-implant; the patients were treated first time using fixed orthodontic appliance; no systemic diseases; were not using anti-inflammatory drugs; Exclusion Criteria: had used antibiotics in the previous 24 months; smokers; had history of radiotherapy, taking bisphosphonate medication
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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Right side of the maxilla<br>the right side of the maxilla | Procedure: Irradiation of implants with 635nm laser<br>* Irradiation of implants with 635nm laser<br>|
| No Intervention: Left side of the maxilla<br>left side of the maxilla | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stability of orthodontic mini-implants | The mini-implants stability was estimated employing a Periotest device (Medzintechnik Gulden e K, Modautal, Germany). The Periotest measurement system includes the sound formed from contact between an object and a metallic tapping bar in a handpiece, which is electromagnetically driven and electronically verified. The Periotest response detection is analyzed through a fast Fourier transform (FFT) algorithm. Simply put, the Periotest answer to tapping is estimated by an accelerometer and then analyzed. The signal generated by tapping is then transformed to a value called the Periotest value (PTV), which depends on the damping characteristics of the peri-implant tissue. [27] The Periotest Test values (PTVs) are based on a numerical scale ranging from -8 to +50, defined by mathematical computation. The lower Periotest values indicate higher implant stability and thereupon the higher absorption effect of the target objects. | 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ATP, biostimulation, micro-screw, Periotest, semiconductor laser