Effect of Photobiomodulation by 808nm Diode Laser on the Stability of Orthodontic Mini-implants.

Study Overview
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Brief Summary
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The study aimed to evaluate the influence of a 635nm diode laser on the stability of orthodontic mini-implants in vitro, as well as mini-implants failure rate (mini-implant loss) and patients pain level after the treatment. A randomized clinical split-mouth trial was concluded with 22 subjects (14 women, 8 men), 44 orthodontic mini-implants with a diameter 1.4mm and length of 10mm. Mini-implants were placed between teeth 3 and 4; and 13 and 14 (Universal Numbering System), in the area of the attached gingiva, 2 mm below mucogingival junction.

Official Title
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Effect of Photobiomodulation by 808nm Diode Laser on the Stability of Orthodontic Mini-implants: 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 808nm 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Right side of the maxilla<br> | Procedure: Irradiation of implants with 808nm laser<br>* Irradiation of implants with 808nm laser<br>|
| No Intervention: Left side of the maxilla<br> | |

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. 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain level (NRS scale) | Each patient received a questionnaire for individual pain assessment (the numeric rating scale, NRS-11, grade level 0-10) immediately following placement of mini-implants. The maximum pain level was measured at both sides of the maxilla during the first day after the treatment. The NRS-11 scale consists of a conscious, subjective assessment of the pain experienced; therefore, it is used in the case of patients over ten years old. 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain. | 24 hours | 
| mini-implants loss | Mini-implants survival rate was assessed during 60 days observation period. | 60 days |