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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01745653
First received: December 4, 2012
Last updated: February 4, 2013
Last verified: February 2013

December 4, 2012
February 4, 2013
April 2011
January 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Each day during the first week post procedure, patient will record intensity of his/her pain on an analogic visual scale
Same as current
Complete list of historical versions of study NCT01745653 on ClinicalTrials.gov Archive Site
  • effect of low level laser therapy on intake of antalgics [ Time Frame: change from baseline antalgics intake at 7 days ] [ Designated as safety issue: No ]
    Each day during the first week post procedure, patient will record his/her intake of antalgics
  • quality of food intake [ Time Frame: change from baseline quality of food intake at 7 days ] [ Designated as safety issue: No ]
    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)).
Same as current
Not Provided
Not Provided
 
Effect of Low Level Laser Therapy on Pain Occurring After Insertion of an Orthodontic Device
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.

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
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Bad Molar Teeth Arrangement Requiring Orthodontic Device
  • Device: Low level laser therapy
    Other Name: low level laser therapy (970nm) (SIROLaser advance material of SIRONA dental systems laboratory)
  • Procedure: sham procedure
    Other Name: Same intervention than experimental arm except that the laser is not activated
  • 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.
    Intervention: Device: Low level laser therapy
  • Sham Comparator: sham procedure
    Same procedure than experimental arm except that the laser is not activated.
    Intervention: Procedure: sham procedure
  • No Intervention: no intervention
    no intervention : Patient received the quadhelix with nothing else
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
69
January 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
8 Years to 15 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01745653
BRD11/3-J
No
Nantes University Hospital
Nantes University Hospital
Not Provided
Not Provided
Nantes University Hospital
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP