Effect of Low Level Laser Therapy on Pain Occurring After Insertion of an Orthodontic Device (Ortholaser)
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|ClinicalTrials.gov Identifier: NCT01745653|
Recruitment Status : Completed
First Posted : December 10, 2012
Last Update Posted : February 5, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Bad Molar Teeth Arrangement Requiring Orthodontic Device||Device: Low level laser therapy Procedure: sham procedure||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||69 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||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"|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2013|
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 Name: 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 Name: 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
- 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
- effect of low level laser therapy on intake of antalgics [ Time Frame: 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 [ Time Frame: 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)).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01745653
|Nantes Universitary Hospital|
|Nantes, Loire Atlantique, France, 44093|