Overview

This trial has been completed.

Condition malocclusion
Treatments fixed orthodontic appliance treatment, orthopulse™, non-functional orthopulse™
Sponsor Biolux Research Ltd.
Start date May 2013
End date May 2016
Trial size 29 participants
Trial identifier NCT02267850, TS2

Summary

The aim of this study is to determine the effect of OrthoPulse™, an intra-oral LED (Light Emitting Diode) photobiomodulation device, on orthodontic treatment time. This is a double-blinded RCT with half the patients receiving treatment from a sham non-functional device, serving as controls, and the other half receiving light therapy treatment from a functional OrthoPulse™. Orthodontic treatment time for the sham-control patients are compared to that of the OrthoPulse™ patients.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Subjects assigned to this group receive fixed orthodontic appliance treatment in conjunction with receiving daily OrthoPulse™ treatments.
fixed orthodontic appliance treatment
Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.
orthopulse™
Patients carry out daily OrthoPulse™ treatments at home.
(Sham Comparator)
Subjects assigned to this group receive fixed orthodontic appliance treatment in conjunction with carrying out daily non-functional OrthoPulse™ treatments (untreated control).
fixed orthodontic appliance treatment
Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.
non-functional orthopulse™
Patients carry out daily sham-OrthoPulse™ treatments at home. This is a non-functional device so patients do not receive photobiomodulation therapy.

Primary Outcomes

Measure
Overall orthodontic treatment time for OrthoPulse™ and non-OrthoPulse™ treated patients.
time frame: Participants will be followed for the duration of their orthodontic treatment, an expected average of 1-2 years, depending on the severity of the case.

Eligibility Criteria

Male or female participants from 12 years up to 40 years old.

Inclusion Criteria: - Presence of permanent dentition - Eligible and scheduled for full mouth fixed orthodontic treatment. - Class I or Class II malocclusion (no more than ½ cusp in Class II) - Non-extraction in all quadrants - Non-smoker, non-use of chewing tobacco - Good oral hygiene - No adjunct treatment such as extra or intraoral appliances - Age 12-40 Exclusion Criteria: - Pregnant females - Patient is currently enrolled in another clinical study - Non-steroidal Anti-Inflammatory drug (NSAID) use during study (Acetominophen acceptable) - Periodontally involved teeth - Use of bisphosphonates - Unerupted erupted teeth - Teeth blocked out of alignment and unable to engage initial arch wire

Additional Information

Official title Effect of Intra-Oral Photobiomodulation on Orthodontic Treatment Time: A Randomized Control Trial
Principal investigator Timothy Shaughnessy, DDS
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Biolux Research Ltd..