Bad Molar Teeth Arrangement Requiring Orthodontic Device
Conditions
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
Interventions
DEVICELow level laser therapy
PROCEDUREsham procedure
Sponsors
Nantes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
8 Years to 15 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| to evaluate the effect of low level laser therapy on pain induced by insertion of the quadhelix (orthodontic device) | change from baseline pain at 7 days | Each day during the first week post procedure, patient will record intensity of his/her pain on an analogic visual scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| effect of low level laser therapy on intake of antalgics | change from baseline antalgics intake at 7 days | Each day during the first week post procedure, patient will record his/her intake of antalgics |
| quality of food intake | change from baseline quality of food intake at 7 days | 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)). |
Countries
France
Outcome results
None listed