Study of the Use of Orthopulse Photobiomodulation

Biolux Technology

Status: Enrolling

Conditions: Orthodontics

Treatments: Other: No intervention; Device: OrthoPulse

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05650359

OP_2021-02

Details and patient eligibility

About

This PMCF study evaluates the safety and performance of OrthoPulse photobiomodulation to accelerate tooth movement during alignment with fixed appliances.

Full description

The purpose of the current clinical investigation performed in form of a post-market clinical follow-up (PMCF) study is to evaluate the performance of OrthoPulse by means of confirming the hypothesis that Subjects in the interventional group (group 1) will have a statistically significant average faster rate of tooth movement during the alignment phase than the average of subjects in the control group (group 2) (estimated 1.8x faster tooth movement) and to substantiate the clinical data for the application of OrthoPulse in case of fixed appliances (brackets).

Enrollment: 42 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age: at least 18 years
• Indication for an orthodontic treatment with fixed appliances
• Presence of a written declaration
• Permanent dentition
• Class I-III malocclusion
• Between 4-10mm of crowding (estimated traditionally) in anterior teeth in mandibular arch (This will depend on the time we choose for the endpoint)

Exclusion criteria

• Simultaneous participation in another clinical investigation or study
• Prior participation in this study
• Persons who have been placed in an institution as a result of an administrative or judicial order
• Persons who are dependent on the sponsor, Investigator or the investigation site
• Anterior cross bite
• Spaces between anterior teeth
• Extractions or missing permanent teeth (except for third molars)
• No anticipated requirement of auxiliary appliances and/or elastics during treatment during alignment phase
• Acute oral infection or periodontal disease
• Active caries
• Pregnant patients or patients planning to become pregnant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

OrthoPulse

Experimental group

Description:

The study population includes a total of 41 patients (based on our sample size calculation), with 21 patients in group 1 and 21 patients in group 2. Eligible study participants are men and women over the age of 18 with permanent dentition who require orthodontic treatment.

Treatment:

Device: OrthoPulse

Control

Active Comparator group

Description:

The study population includes a total of 41 patients (based on our sample size calculation), with 21 patients in group 1 and 21 patients in group 2. Eligible study participants are men and women over the age of 18 with permanent dentition who require orthodontic treatment.

Treatment:

Other: No intervention