Study of the Use of Orthopulse Photobiomodulation

Not Applicable

Recruiting

• Conditions: Orthodontics
• Interventions: Device: OrthoPulse; Other: No intervention

• Registration Number: NCT05650359
• Lead Sponsor: Biolux Technology GmbH

Brief Summary

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

Detailed 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).

Study Timeline

• Study Start: 2022-10-13
• Study First Submitted: 2022-12-06
• Study First Submitted QC: 2022-12-06
• Study First Posted: 2022-12-14
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-07
• Primary Completion: 2028-05-15
• Study Completion: 2028-05-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OrthoPulse	OrthoPulse	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.
Control	No intervention	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.

Primary Outcome Measures

Name	Time	Method
The primary endpoint of this PMCF study is the rate of tooth alignment.	42 days after start of treatment	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.

Trial Locations

Locations (1)

Private Practice; 🇺🇸 Chandler, Arizona, United States