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
  Purpose

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 Intervention
Bad Molar Teeth Arrangement Requiring Orthodontic Device
Device: Low level laser therapy
Procedure: sham procedure

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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"

Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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)).


Enrollment: 69
Study Start Date: April 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   8 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01745653

Locations
France
Nantes Universitary Hospital
Nantes, Loire Atlantique, France, 44093
Sponsors and Collaborators
Nantes University Hospital
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01745653     History of Changes
Other Study ID Numbers: BRD11/3-J
Study First Received: December 4, 2012
Last Updated: February 4, 2013
Health Authority: France: Committee for the Protection of Personnes

ClinicalTrials.gov processed this record on July 20, 2014