Low-level Laser Therapy With a 635nm Diode Laser on Orthodontic Mini-implants Stability.

Study Overview
=================
Brief Summary
-----------------
The study aimed to clinically estimate an influence of a 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 20 patients (13 women and 7 men; age: 32.5 ± 6.1 years).

Official Title
-----------------
Low-level Laser Therapy With a 635nm Diode Laser Affects Orthodontic Mini-implants Stability. A Randomized Clinical Split-Mouth Trial.

Conditions
-----------------
Malocclusion, Angle Class II

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


Participation Criteria
=================
Eligibility Criteria
-----------------
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
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

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 635-nm laser parameters; dose: 10J per point (20J/cm2), time: 100 sec per point, 2 points (irradiation on a buccal, and a palatal side of the alveolus/implant), the total energy per session 20J. | Procedure: Irradiation of implants with 635nm laser<br>* Irradiation of implants with 635nm laser with a dose of 10J<br>|
| No Intervention: Left side of the maxilla<br> | |

What is the study measuring?
-----------------
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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain level | Immediately after the mini-implants placement, each patient received a questionnaire for individual pain assessment (the numeric rating scale, NRS-11, grade level 0-10). 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. A rating of 0 signifies no pain, 1-3 represents mild pain, 4-6 moderate pain, and 7-10 severe pain. | 24 hours | 
| mini-implants loss |  | 60 days | 

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