User's Guide

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were excluded. There were no differences between groups in terms of
gender, ethnicity, age, and initial crowding. The rate of tooth move-
ment was measured using the change in Little’s Irregularity Index
measurements in both groups to evaluate OrthoPulse® use with fixed
orthodontic appliances. Root resorption was determined by use of
panoramic dental X-rays collected before treatment and after 6
months of treatment. Results demonstrated that subjects treated
with OrthoPulse® showed a statistically significantly faster rate of
tooth movement (p<0.001) compared to the control group, achieving
the primary effectiveness objective of the study. There were no seri-
ous adverse events, and no gingival recession or pathological tooth
mobility reported throughout the study. Data demonstrated the
absence of external apical root resorption with OrthoPulse® use, and
that there is no device effect of accelerated tooth movement on tooth
root integrity.
Several additional clinical studies were also conducted with prototype
and final OrthoPulse® devices to supplement the clinical findings
observed in the primary studies, and results consistently confirmed
device performance for its indicated use.
Therefore, results from the clinical studies demonstrate that subjects
treated with OrthoPulse® achieve statistically significantly faster
rates of tooth movement than control. The amount of change in an
individual’s tooth movement rate during OrthoPulse® daily treatment
may be dependent upon their specific biology and treatment plan. For
clear aligners, only Invisalign brand aligners have been examined with
daily OrthoPulse® use. Results with other brands of aligners may vary.
1.3 Contraindications for Use
• Use of osteoporosis drugs
• Use of drugs that may cause photosensitivity
• Photosensitivity
1
• Poor oral hygiene
• Acute oral infection, active periodontal disease or oral cancer
• Epilepsy
A dental professional should be consulted prior to use if any of these
situations are suspected.
2. How to Use
2.1 Steps and Schedule for Use
An OrthoPulse® treatment takes five minutes per arch for a total of
ten minutes daily.
2
It is recommended to select the same time every-
day to do your treatment.
Caution: To maximize the life of your device and to avoid
potential overheating of the device do not use the OrthoPulse®
device for more than two 5-minute sessions subsequently.
The status light guide is available on the bottom of the OrthoPulse®
charging case.
Typically, it takes two to three weeks to develop a habit, so be patient.
Some patients prefer to set up OrthoPulse® next to their bed, so they
can do treatments first thing upon rising or prior to sleeping.
1 A condition in which the skin becomes very sensitive to sunlight
or other forms of ultraviolet light and may burn easily.
2 there are no benefits of doing more than 2 sessions.