Completed

NCT Number: NCT02181439

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

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)

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Key information

Conditions

Class II Canine Elastics II Intermaxillary Strength Multi Fasteners Orthodontic Treatment

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de NANTES - Service d'odontologie restauratrice et chirurgicale, UIC odontologie

Nantes, 44042 Nantes Cedex, France

Who can participate

Healthy volunteers accepted: No

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

Pre-inclusion criteria:

Written consent of parental authority, ie if any of the two parents, will be required, but the apparent unwillingness of the child shall prevail if any.

No exclusion period is required if the child has already attended another biomedical research.

Inclusion criteria

With a Class II canine complete or partial, bilateral and symmetrical
In permanent dentition (no deciduous teeth in the arch)
Requiring the use of intermaxillary strength (FIM) II correction dental class II during a multi fasteners orthodontic treatment
Leveling done beforehand*
Anchor of the mandible is maximum

The same technique employed should be segmented in the maxilla, in all patients (lateral sectional canine to molar).

Exclusion criteria

Patient :

having a mental deficiency or child who can not read or write (difficulties in completing the questionnaire )
with lack of cooperation (withdrawal, refuse to wear FIM II)
who missed at least 3 consecutive appointments according to the medical record ,
with orofacial malignant tumor
having unbalanced chronic diseases or patient receiving treatment that can interfere with orthodontic treatment or with pain assessment (antibiotics, analgesics, treatment of bone and mineral metabolism, diabetes, hormonal treatments excluding contraceptives)
with a Class II dental unilateral and asymmetric
with a dental anomaly from shape and / or structure related to the following teeth: maxillary canines and first molars causing an increased risk of detachment brackets
with anomalies of number : agenesis of permanent teeth
with a mixed dentition
refusing to give consent or with one or two parents refusing to give their consent (for minor patients)
participating in another biomedical research
pregnant

Treatment and study plan

(LLLT Low Level Laser Therapy) SiroLaser advance

Device

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.

Primary outcomes

Delays in obtaining Class I canine right and left

Time frame: 6 months

For each sector, obtaining or not the class I will be assessed each month up to 6 months. The difference of delay in obtaining Class I between sectors will be calculated for each patient. For this reason, the primary outcome assessment will be done after 6 months of follow-up + 18 months of inclusion period, i.e. 24 months after starting inclusions.The comparison will be made from a student test on the difference in time required to obtain Class I between sectors.

If class I is obtained on each sector (right and left) prior to the 6-month FUp, the corresponding visit is considered as the last one for the patient within the study.

Secondary outcomes

Total distance covered by the maxillary canine (mm) until the Class I canine

Time frame: 6 months

The total distance until the class I will be collected for each sector and will be compared using a student test.
Intensity pain jaw

Time frame: 6 months

Intensity pain jaw while wearing FIM II = quantitative pain assessment in the maxilla via EVA, by right and left during the first 3 days of FIM II port via a patient diary Jaw pain felt in each sector will be collected over 3 days. Comparison to be made each time from a student test on the difference in jaw pain felt across sectors.
speed in obtaining Class I canine right and left

Time frame: 6 months

total distance until the class I/ Delay in obtaining Class I

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

Single-center, Controlled, Randomized and Double-blind Study Evaluating the Laser Diode Effect on the Kinetics of Orthodontic Tooth Movement.

Acronym: CINELASER

Important dates

Study start: 2014
Primary completion: 2017
Study completion: 2018
First posted: Jul 4, 2014
Registry last updated: Dec 5, 2018

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.