Effect of Low Level Laser Therapy on Pain Occurring After Insertion of an Orthodontic Device

Study Overview
=================
Brief Summary
-----------------
Thus study consists of evaluating the effect of low level therapy on pain induced by insertion of an orthodontic device (the quadhelix). Each day during the first seven days post procedure, the level of pain will be reported on an analogic visual scale. As secondary objectives, intake of antalgics and type of swallowed food (soft or tough) will also be daily registered.

Detailed Description
-----------------
Patient will be randomized into one of the 3 following arms : arm 1 (experimental) : administration of Low Level Laser Therapy just after insertion of the quadhelix. arm 2 (sham procedure) : material necessary to perform Low Level Laser Therapy will be installed but the laser will not be activated. arm 3 (no intervention): material necessary to perform Low Level Laser Therapy will NOT be installed

Official Title
-----------------
Monocentric, Randomized, Single Blinded Study Designed to Evaluate the Effect of Low Level Laser Therapy on Pain Occurring After Insertion of an Orthodontic Device : the Quadhelix

Conditions
-----------------
Bad Molar Teeth Arrangement Requiring Orthodontic Device

Intervention / Treatment
-----------------
* Device: Low level laser therapy
* Procedure: sham procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children aged between 8 and 15 years old who need to receive an orthodontic device (quadhelix) informed consent form signed by parents who should be affiliated to French health insurance (french Social security) Exclusion Criteria: malignant facial tumor not able to read or write correctly and thus not able to complete the questionnaire allergic or intolerant to paracetamol Informed consent not obtained

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 15 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low level laser therapy<br>Low level laser (970nm) will be delivered on the mucous membrane in regard to the first molar teeth on which rings of the quadhelix have been settled. | Device: Low level laser therapy<br> <br> * Other names: low level laser therapy (970nm) (SIROLaser advance material of SIRONA dental systems laboratory);|
| Sham Comparator: sham procedure<br>Same procedure than experimental arm except that the laser is not activated. | Procedure: sham procedure<br> <br> * Other names: Same intervention than experimental arm except that the laser is not activated;|
| No Intervention: no intervention<br>no intervention : Patient received the quadhelix with nothing else | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to evaluate the effect of low level laser therapy on pain induced by insertion of the quadhelix (orthodontic device) | Each day during the first week post procedure, patient will record intensity of his/her pain on an analogic visual scale | change from baseline pain at 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effect of low level laser therapy on intake of antalgics | Each day during the first week post procedure, patient will record his/her intake of antalgics | change from baseline antalgics intake at 7 days | 
| quality of food intake | Each day during the first week post procedure, patient will answer (on a questionnaire) to questions concerning his/her intake of food (type of food (soft or not)). | change from baseline quality of food intake at 7 days |