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Photobiomodulation
OrthoPulse Light Therapy for Teeth Alignment
N/A
Recruiting
Led By Todd Dickerson
Research Sponsored by Biolux Technology GmbH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 42 days after start of treatment
Awards & highlights
Study Summary
This trial tests a new way to speed up teeth alignment with fixed braces, using a safe light therapy.
Who is the study for?
This trial is for adults with 4-10mm crowding in lower front teeth, needing braces for Class I-III malocclusion. Candidates must not be institutionalized by order, dependent on the sponsor or site, have gaps in front teeth, need other oral devices during the study phase, have untreated cavities or missing teeth (except wisdom), be in another study or this one before, have a crossbite upfront, or be pregnant/planning pregnancy.Check my eligibility
What is being tested?
The study tests OrthoPulse photobiomodulation's safety and effectiveness to speed up tooth movement with braces. Participants will either receive OrthoPulse treatment alongside regular orthodontic care or undergo standard treatment without additional interventions.See study design
What are the potential side effects?
While specific side effects are not detailed here, photobiomodulation generally has minimal risks which may include mild discomfort at the application site. The procedure is non-invasive and considered safe.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 42 days after start of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~42 days after start of treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The primary endpoint of this PMCF study is the rate of tooth alignment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: OrthoPulseExperimental Treatment1 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.
Group II: ControlActive Control1 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.
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Who is running the clinical trial?
Biolux Technology GmbHLead Sponsor
medXteam GmbHOTHER
1 Previous Clinical Trials
1,000 Total Patients Enrolled
Todd DickersonPrincipal InvestigatorPrivate Practice 1200 W Warner Rd, Chandler, AZ 85224
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have missing teeth, not including wisdom teeth.I have gaps between my front teeth.I currently have untreated cavities.I am 18 years old or older.I have all my adult teeth.My front teeth overlap in the wrong way.My lower front teeth are crowded by 4-10mm.I need braces for my teeth.I have a misaligned bite or crooked teeth.I do not have any current mouth or gum infections.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: OrthoPulse
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still openings in this trial for those seeking treatment?
"According to the clinicaltrials.gov, this trial has been recruiting participants since October 13th 2022 and is still looking for qualified candidates. The most recent update was made on December 6th 2022."
Answered by AI
What is the total participant count of this research endeavor?
"Correct. Clinicaltrials.gov documents this clinical trial as presently seeking participants, with first postings on October 13th 2022 and most recently updated on December 6th 2022. The research is targeting 42 people from a single location."
Answered by AI
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