Investigation of the Photobiomodulation Applications

Study Overview
=================
Brief Summary
-----------------
Increasing the speed of orthodontic treatment is an emerging clinical problem and therefore the evaluation of the effects of photobiomodulation applications and methods on orthodontic tooth movement is considered as an important factor. When literature studies are examined, different studies have been performed on Laser and LED applications, however, the lack of a study that evaluates and compares the effectiveness of these methods in terms of clinical and biochemical parameters. The aim of this study is to compare the effects of laser and LED applications on tooth movement speed and to investigate the effects of these applications on the gingival fluid IL-8, OPG, RANKL. Total of 24 patients with maxillary first-premolar extraction orthodontic treatment will be included in this study, and this study will consist of 3 groups, Laser, LED and placebo group. The laser will be applied on days 0,3,7,14,21,28,35, take impression of teeth and gingival fluid samples will be collected in these days. LED group will be given 10 minutes LED for 30 days, taken impression and DOS samples will be collected on specified days. In the placebo group, the non-active pulse laser light will be kept in the teeth and the patients will not know which group in they are. Thus, the psychological dimension of the applications will be eliminated. Sampling will be done for the placebo group on the days determined. The investigator's project proposal consists of a total of 5 work packages; Determination of patient groups in the 1st stage and obtaining consent forms, 2nd stage Photobiomodulation applications (laser, LED, placebo application), 3rd stage orthodontic measurement and evaluation of these measurements 3D environment, taking gingival fluid samples in the 4th stage and evaluating them biochemically. In the 5th stage, statistical analysis and evaluation of the results will be done. The data will be evaluated with SPSS 21.0.In this study, it is tried to reduce the time spent in the orthodontic treatment to close the extraction area. In this way, it will contribute to economy and time saving in terms of all orthodontic treatment physicians and physicians. It will illuminate the application of LED device which is more advantageous in terms of cost and space gain in clinical practice of physicians.

Official Title
-----------------
Investigation of the Effects of Photobiomodulation Applications on Orthodontic Tooth Movement

Conditions
-----------------
Orthodontic Tooth Movement

Intervention / Treatment
-----------------
* Device: Cheese dental laser
* Device: OrthoPulse
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adequate oral hygiene Class 2 malocclusion requiring upper-premolar extraction orthodontic treatment lack of congenital missing teeth in upper jaw no systemic disease Exclusion Criteria: patients who wish to discontinue treatment patients who cannot provide oral hygiene

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tooth Movement<br>Canine distalization on premolar extracted patients | Device: Cheese dental laser<br>* 810 nm GaAlAs diode laser device<br>Device: OrthoPulse<br>* 850 nm LED (light emitting diode)<br>Other: Placebo<br>* 810 nm GaAlAs diode laser device<br>|
| Experimental: Biochemistry measurements<br>biochemistry analysis of IL-8, OPG, RANKL | Device: Cheese dental laser<br>* 810 nm GaAlAs diode laser device<br>Device: OrthoPulse<br>* 850 nm LED (light emitting diode)<br>Other: Placebo<br>* 810 nm GaAlAs diode laser device<br>|
| Experimental: periodontal measurements<br>gingival and plaque index, blooding on probing, pocket depth | Device: Cheese dental laser<br>* 810 nm GaAlAs diode laser device<br>Device: OrthoPulse<br>* 850 nm LED (light emitting diode)<br>Other: Placebo<br>* 810 nm GaAlAs diode laser device<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Orthodontic tooth movement Change | Measurement of orthodontic tooth movement (mm) | 1st, 3rd, 7th, 14th, 21th, 28th, 35th day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gingival Index Change | Measurements of gingival index (according to Silness&Löe) all of teeth from 6 surface. Scale ranged from 0 to 3. All data will calculated for total mouth score. | 1st, 3rd, 7th, 14th, 21th, 28th, 35th day | 
| Plaque Index Change | Measurements of gingival index (according to Löe&Silness) all of teeth from 6 surface. Scale ranged from 0 to 3. All data will calculated for total mouth score. | 1st, 3rd, 7th, 14th, 21th, 28th, 35th day | 
| RANKL Change | Analyses of RANKL level in gingival crevicular fluid. The analysis will perform via ELISA. Data will present pg/30sn | 1st, 3rd, 7th, 14th, 21th, 28th, 35th day | 
| OPG Change | Analyses of OPG in gingival crevicular fluid | 1st, 3rd, 7th, 14th, 21th, 28th, 35th day | 
| IL-8 Change | Analyses of IL-8 in gingival crevicular fluid | 1st, 3rd, 7th, 14th, 21th, 28th, 35th day | 
| Bleeding on Probing Change | Estimation of bleeding on probing. The reason for the Bleeding of Probing measurement is for the control of oral hygiene motivations in patients' follow-up. | 1st, 3rd, 7th, 14th, 21th, 28th, 35th day | 
| Periodontal Pocket Depth Change | Measurement of Periodontal Pocket Depth (mm) | 1st, 3rd, 7th, 14th, 21th, 28th, 35th day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
orthodontics, tooth movement