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"
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bad Molar Teeth Arrangement Requiring Orthodontic Device
- Sponsor
- Nantes University Hospital
- Enrollment
- 69
- Locations
- 1
- Primary Endpoint
- to evaluate the effect of low level laser therapy on pain induced by insertion of the quadhelix (orthodontic device)
- Status
- Completed
- Last Updated
- 13 years ago
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
Investigators
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
Outcomes
Primary Outcomes
to evaluate the effect of low level laser therapy on pain induced by insertion of the quadhelix (orthodontic device)
Time Frame: 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 Outcomes
- effect of low level laser therapy on intake of antalgics(change from baseline antalgics intake at 7 days)
- quality of food intake(change from baseline quality of food intake at 7 days)