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

Not Applicable

Completed

• Conditions: Bad Molar Teeth Arrangement Requiring Orthodontic Device
• Interventions: Procedure: sham procedure; Device: Low level laser therapy

• Registration Number: NCT01745653
• Lead Sponsor: Nantes University Hospital

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

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2012-12-04
• Study First Submitted QC: 2012-12-07
• Study First Posted: 2012-12-10
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-04
• Last Update Posted: 2013-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sham procedure	sham procedure	Same procedure than experimental arm except that the laser is not activated.
Low level laser therapy	Low level laser therapy	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)).

Trial Locations

Locations (1)

Nantes Universitary Hospital; 🇫🇷 Nantes, Loire Atlantique, France