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Study Evaluating the Laser Diode Effect on the Kinetics of Orthodontic Tooth Movement (Protocol CINELASER)

NCT02181439 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2018-12-05

No results posted yet for this study

Summary

It is a single-center, prospective clinical study of a medical device, controlled, randomized, non-stratified, double-blind (neither the patient nor the parents know which area is irradiated / practitioner who performs the measures and evaluates the class I achievement or non also ignores the irradiated area) .

Children included in this clinical trial will be their own control, an area receiving LASER irradiation the other receiving a simulation LASER irradiation (placebo side, inactive laser) .

In the maxilla, it will be segmented using a technique by the introduction of sectional side (portion of elgiloy arch supporting molars, canines and premolars) which serve as a support for Intermaxillary Strength II (or Intermaxillary Elastics II).

The patient should put his own Intermaxillary Elastics II, force adapted to the amount of class II dental, and this 24h/24. The patient should position him/herself these intermaxillary elastics in the first mandibular molar to the maxillary canine ; their action, in case of maximum mandibular anchorage, is to reduce maxillary canine in order to obtain reports of class I. In the mandible, a maximum anchor will be realized. Maximum molar anchor is to place the roots of mandibular molars in the vestibular cortex in order to anchor them there. This allows the lower canines, premolars and maxillary molars under the action of FIM without causing mutual advancement of the mandibular arch.

This procedure does not differ from the usual treatment. The application of laser diode appears, by biomodulatrice action, to show promising results on accelerating the kinetics of tooth movement during orthodontic treatment. The main hypothesis of the research is an increase in the rate of correction of Class II irradiated side, i.e. a 1-month shortest delay in obtaining the class I for irradiated areas vs. non irradiated ones.

The main objective of this study is to evaluate the effect of the application of low energy laser (LLLT) on the time required to obtain a Class I canine on patients undergoing FIM II (Class II elastics)

Conditions

  • Class II Canine
  • Intermaxillary Strength
  • Elastics II
  • Multi Fasteners Orthodontic Treatment

Interventions

DEVICE

(LLLT Low Level Laser Therapy) SiroLaser advance

Irradiation scanning distance of the mucosa over an area ranging from the mesial surface of the maxillary canine to the distal surface of the maxillary first molar in the sagittal direction, and the CEJ to the bottom of the vestibule in the vertical direction.

Sponsors & Collaborators

  • Nantes University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-16
Primary Completion
2017-12-13
Completion
2018-05-18

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02181439 on ClinicalTrials.gov