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

Nantes University Hospital (NUH)

Status: Completed

Conditions: Bad Molar Teeth Arrangement Requiring Orthodontic Device

Treatments: Device: Low level laser therapy; Procedure: sham procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT01745653

BRD11/3-J

Details and patient eligibility

About

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.

Full 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

Enrollment: 69 patients

Sex: All

Ages: 8 to 15 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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69 participants in 3 patient groups

Low level laser therapy

Experimental group

Description:

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.

Treatment:

Device: Low level laser therapy

sham procedure

Sham Comparator group

Description:

Same procedure than experimental arm except that the laser is not activated.

Treatment:

Procedure: sham procedure

no intervention

No Intervention group

Description:

no intervention : Patient received the quadhelix with nothing else