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

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"

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.

Study Overview

• Status: Completed
• Conditions: Bad Molar Teeth Arrangement Requiring Orthodontic Device
• Intervention / Treatment: Device: Low level laser therapy; Procedure: sham procedure

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 Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Loire Atlantique
    • Nantes, Loire Atlantique, France, 44093
      • Nantes Universitary Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Low level laser therapy; Other Names: low level laser therapy (970nm) (SIROLaser advance material of SIRONA dental systems laboratory)
Sham Comparator: sham procedure; Same procedure than experimental arm except that the laser is not activated.	Procedure: sham procedure; Other Names: Same intervention than experimental arm except that the laser is not activated
No Intervention: no intervention; 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

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: December 4, 2012
• First Submitted That Met QC Criteria: December 7, 2012
• First Posted (Estimate): December 10, 2012

Study Record Updates

• Last Update Posted (Estimate): February 5, 2013
• Last Update Submitted That Met QC Criteria: February 4, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: BRD11/3-J