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

NCT01745653 | Completed

• 1 other identifier: BRD11/3-J
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bad Molar Teeth Arrangement Requiring Orthodontic Device

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• effect of low level laser therapy on intake of antalgics

  change from baseline antalgics intake at 7 days

• quality of food intake

  change from baseline quality of food intake at 7 days

Study Arms (3)

Low level laser therapy

EXPERIMENTAL

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

sham procedure

SHAM COMPARATOR

Same procedure than experimental arm except that the laser is not activated.

Procedure: sham procedure

no intervention

NO INTERVENTION

no intervention : Patient received the quadhelix with nothing else

Interventions

Low level laser therapy DEVICE

Also known as: low level laser therapy (970nm) (SIROLaser advance material of SIRONA dental systems laboratory)

Low level laser therapy

sham procedure PROCEDURE

Also known as: Same intervention than experimental arm except that the laser is not activated

sham procedure

Eligibility Criteria

• Age: 8 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes Universitary Hospital

Nantes, Loire Atlantique, 44093, France

Location

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2012
• First Posted: December 10, 2012
• Study Start: April 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: February 5, 2013

Record last verified: 2013-02

Locations

FR (1)