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Completed

NCT Number: NCT01745653

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

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.

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Key information

Conditions

Bad Molar Teeth Arrangement Requiring Orthodontic Device

Age range

8 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nantes Universitary Hospital

Nantes, Loire Atlantique, 44093, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low Level Laser Therapy

Device

Other names: low level laser therapy (970nm) (SIROLaser advance material of SIRONA dental systems laboratory)

Sham Procedure

Procedure

Other names: Same intervention than experimental arm except that the laser is not activated

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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)).

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study 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"

Acronym: Ortholaser

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Dec 10, 2012
Registry last updated
Feb 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.