Study of the Use of Orthopulse Photobiomodulation

NCT05650359 | Recruiting FDA Device

• 1 other identifier: OP_2021-02
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Orthodontics

Outcome Measures

Primary Outcomes (1)

• The primary endpoint of this PMCF study is the rate of tooth alignment.

  The primary endpoint of this PMCF study is the rate of tooth alignment as per Little's irregularity index LII (measured as the distance of linear displacement in mm divided by a unit of time between the lower arch anterior 6 teeth) during the time between baseline and 42 days after start of treatment.

  42 days after start of treatment

Study Arms (2)

OrthoPulse

EXPERIMENTAL

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.

Device: OrthoPulse

Control

ACTIVE COMPARATOR

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.

Other: No intervention

Interventions

OrthoPulse DEVICE

The OrthoPulse device is intended to accelerate orthodontic movement of teeth and reduce the overall treatment time for the patient. The device is intended to be used in conjunction with traditional orthodontic treatment with brackets and wires or aligners. OrthoPulse is an intra-oral (iO), Light Emitting Diode (LED) based, phototherapy device for the stimulation of metabolic activity of the alveolar bone, and the acceleration of orthodontic tooth movement during orthodontic treatment. The device uses safe, high-power LED arrays to produce photons at therapeutic wavelengths in the near infrared (nIR) portion of the light spectrum. OrthoPulse is an established device that uses low levels of light energy to stimulate the bone surrounding the roots of teeth and facilitate tooth movement which may reduce treatment time for braces or clear aligners.

OrthoPulse

No intervention OTHER

No intervention

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Biolux Technology GmbH: lead
• medXteam GmbH: collaborator

Study Sites (1)

Private Practice

Chandler, Arizona, 85224, United States

RECRUITING

Study Officials

• Todd Dickerson

  Private Practice 1200 W Warner Rd, Chandler, AZ 85224

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniela Penn

CONTACT

063219164033; daniela.penn@medxteam.de

Mark N. Coreil, DDS

CONTACT

337-412-2134; mark@drcoreil.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: None (Open Label)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a prospective, randomized, controlled, open-label, multicenter PMCF study.

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: December 14, 2022
• Study Start: October 13, 2022
• Primary Completion (Estimated): May 15, 2028
• Study Completion (Estimated): May 15, 2028
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)