Periodontal Gum Disease

Periodontal gum disease is a serious infection of the mouth that, if left untreated, can lead to tooth loss and is known to be a contributing factor in developing numerous serious diseases. Research has shown that chronic oral infections are associated with, and may contribute to life threatening health problems such as heart disease, strokes, diabetes, spontaneous pre-term births and low-weight babies.

Periodontal disease can affect one tooth or many teeth. It begins when the bacteria in plaque (the sticky, colorless film that constantly forms on everyone's teeth) causes the gums to become infected and inflamed. In the mildest form of the disease, gingivitis, the gums redden, swell and bleed easily.  There is usually little or no discomfort. Gingivitis is often caused by inadequate oral hygiene, especially lack of flossing and is reversible with professional treatment and good oral home care.

Untreated gingivitis can advance to periodontitis.  With time, plaque can spread and grow below the gum line. Toxins produced by the bacteria in plaque irritate and inflame the gums.  The toxins stimulate a chronic inflammatory response in which the body in essence turns on itself and the gums, ligaments and bone that support the teeth are broken down and destroyed.  Gums separate from the teeth, forming pockets (spaces between the teeth and gums) that become infected.  As the disease progresses, the pockets deepen and more gum tissue, ligaments and bone are broken down and destroyed.  Initially this destructive process has very mild symptoms and the patient may not be aware he has a serious infection and the damage it is causing below the gum line.  Eventually, teeth can become loose and may be lost or have to be removed.  This pernicious infection can be present for years and is believed to adversely affect the body's immune system making it more susceptible to numerous serious diseases.

More than 300 different types of bacteria exist in the human mouth, either alone or in combination.  This makes treating periodontal disease difficult, time consuming and expensive as the periodontist tries various antibiotics and treatment modalities until an effective treatment plan is developed.

To add to the periodontist's difficulty, the existing manual pick and probe methodology currently used to diagnose periodontal disease and monitor its treatment (described below) is disruptive to the healing process and very inaccurate so the treatment plan's effectiveness may not be readily ascertainable.  This can result in a trial and error approach that can last for many months and be very time consuming and expensive.  In the meantime, as the patient's immune system fights this chronic and perhaps serious infection, it creates an opportunity for other serious diseases to develop.  Like any other serious infection, if not promptly treated with the proper types and amounts of antibiotics, periodontitis can result in severe systemic infection that can even become life-threatening.

Description of the Current Method to Detect Periodontal Disease

The current primitive methodology used by dentists and dental hygienists to detect and measure periodontal disease consists of a sharp metal probe that is repeatedly inserted between the tooth and gum and which is pressed down until it encounters the ligament.  The depth of the ligament is thereby measured and indicates the amount of periodontal disease that may be present.  This method can be painful, and is invasive, bloody, extremely inaccurate, subjective, analog and labor and time intensive (most measurements are written down by hand and usually require two people to perform the test).  It is also severely limited in its effectiveness at diagnosing periodontal disease in its earliest stages as it is a retrospective analysis and can only measure significant amounts of tissue already lost (i.e., after serious damage has occurred).  In undergoing this test, patients are at risk that the infection will be pushed below their gums into their bloodstreams (i.e., septicemia).

Description of the Perio-Imager

The Perio-Imager is a unique ultrasonographic digital imaging and diagnostic tool for effectively detecting, mapping, characterizing and evaluating the presence, and monitoring the treatment of periodontal disease.  It also provides qualitative information regarding the presence and location of calculus (i.e, hardened plaque) present on the tooth surface below the gum line.

The Perio-Imager is a precision, state-of-the-art instrument that integrates proven diagnostic medical imaging ultrasound technology used extensively and safely by the medical profession in fields like cardiology and obstetrics as well as in aerospace and nuclear submarine structural flaw detection for many years and modified and enhanced so dentists can safely and effectively use it.

The complete Perio-Imager consists of a unique and proprietary hand piece (See Figures 3 and 4) and a compact, chair-side, large touch-screen, computer console unit and proprietary, advanced artificial intelligence software for data acquisition, conversion and display.  The hardware includes an ultrasonographic transmitter and receiver (i.e., the transducer), water flow control devices, electrical connectors and circuit boards to control, acquire, process and convert the signals into a series of user-friendly images.

The Perio-Imager's unique and proprietary hand piece directs a gentle drip of water (or other liquid such as an anti-bacterial agent) between the gum and the tooth.  The transducer in the tip of the hand piece rapidly produces and transmits several ultrasonographic signals (i.e., sonar waves) that use the liquid as the signal coupler and travel down the drip of water along each tooth's surface and below the gum line until they reach the ligament attachment to the tooth (i.e., into the periodontal pockets).

These signals then bounce back to the transducer from the ligament attachment point by traveling back up the liquid. The transducer then captures the corresponding echoes resulting from their collision with anatomical features below the gum line and they are thereby analyzed, timed and measured. The periodontal condition is then automatically mapped (i.e., the depth of each tooth's pockets is thereby measured) by analyzing these received sonar echoes.

Embedded software within the computer converts the incoming signals from an analog to a digital format and uses proprietary algorithms to interpret and convert the echoes corresponding to the depth of the outer boundary of the periodontal ligament into a dimension (e.g., pocket depth in millimeters) and to detect the presence of and locate calculus on the tooth's surface so it can be more easily and effectively removed.

The Perio-Imager's advanced artificial intelligence software then provides dentists with a user friendly series of images and a unique method to effectively map and thereby provide important information regarding the true condition of the patient's mouth below the gum line including the presence and exact location of calculus.  It digitally stores the pocket depths of each tooth and their variation over time and other important diagnostic and patient information.  This information is also stored at PII's website.  See Figures 5, 6 and 7 annexed hereto that illustrate some of the periodontal measurement, charting results and patient management information the Perio-Imager makes available to dentists.

The Perio-Imager also provides dentists with important information not currently available because it performs two types of measurements: it measures the patients' periodontal pocket depths from the gum line (which can change over time) and it also measures the patients' periodontal pocket depths from the cemento-enamel junction ( “CEJ” ) below the gum line (which never changes) and which is not visible to the dentist.  This information greatly assists dentists in the diagnosis, and as an indicator of the extent and severity of periodontal disease and the effectiveness of their treatment plan.

The entire test is fully computerized and all patient information is digitally recorded by the person performing the test.  The exam results and other information can be viewed on the Perio-Imager's screen or sent wirelessly or via cable to additional screens in the operatory and/or to the dentist's computer server.  The Perio-Imager is easily and quickly moved between operatories.

Patients will establish a baseline of their periodontal pocket depths during their first exam.  After their first test, each time the patient takes a new test, the digital images from the prior tests can be graphically, quantitatively and automatically overlaid over the current test.  This permits dentists and their patients to identify even relatively minor changes in periodontal pocket depths not otherwise detectable using the current manual probing technology.  If desired, dentists can provide their patients with a computerized printout of their test results that confirms treatment is necessary.  This substantially reduces the number of “walk-aways” that decline treatment because they cannot confirm their dentist's recommendation.  The printouts also can show patients that their dentist's treatment plan is working and should be continued by providing patient friendly images with colored trend-lines.

Comparison of the Manual Probe and the Perio-Imager

The Perio-Imager provides dentists and their patients with a vastly superior method to effectively diagnose and evaluate periodontal disease and monitor its treatment.  This enables dentists to detect periodontal disease and begin treatment in its earliest stage when it is easy and inexpensive to treat and before significant damage or disease can occur. It also permits dentists and dental hygienists to more easily and effectively clean their patients' teeth by providing information regarding the presence and location of calculus present on tooth surfaces below the gum line.

As a result of these considerable advantages, PII believes that the Perio-Imager will become the “gold standard” of the dental profession for effectively detecting and monitoring the treatment of periodontal disease thereby requiring virtually all dentists to use it on all of their adult patients on a regular basis.

The Perio-Imager provides the following benefits to patients, dentists and payors:

• For patients, the test is non-invasive, painless, bloodless and inexpensive.
• For dentists, the test is fast, accurate, objective and digital.  Dentists can immediately provide patients and payors with a paper or electronic copy of the test results and are expected to generate substantial additional practice revenues from additional periodontal testing and early-stage periodontal disease treatment fees.  Proof that treatment is necessary can be shown to the patient on-screen and e-mailed to payors.  A back-up copy of each patient's digital records are stored in a HIPAA compliant manner at PII's Web-Site.
• For payors, the test can accurately, objectively and digitally confirm the presence and extent of periodontal disease.  More and more dental insurance companies and other payors are requiring digital proof of the patient's condition from dentists to confirm that treatment was necessary.

Ease of Use of the Perio-Imager.

The Perio-Imager uses quick-connect / disconnect electrical and water fittings that make it easy to quickly move it between operatories.

The Perio-Imager creates user friendly images of the applicable teeth showing their true periodontal condition.  This is accomplished by using the dentist's or PII's dental imaging software and then sending the image to the Perio-Imager's large, color touch-screen.  If the dentist wants to view the test results on another screen in his operatory, the Perio-Imager will transmit the images to the dentist's screen on a wireless or wired basis.  The dentist can input all patient information using the Perio-Imager's large, user-friendly touch-screen.

All tests will be performed after the dentist or dental hygienist connects to PII's web-site via the Internet.  This will permit PII to confirm the Perio-Imager is properly calibrated and working perfectly prior to each test and that the dentist's account has been properly charged the $10 test fee.

The Perio-Imager provides a series of audible tones and visual signals to guide the dentist through the test thereby permitting the dentist to advance to the next tooth or to reverse back to the last tooth and re-test it if the image was not properly captured.  These signals can also alert the dentist to the presence of unusually deep periodontal pockets which may signify significant periodontal disease.

The Perio-Imager is fully self-contained and will provide the necessary images on its own screen even if there are problems with the signal (for example, the walls may contain lead due to the use of x-ray equipment).  In addition, all of the patient's information can be sent to the dentist's office computer wirelessly or via a cable connection so that patient information does not have to be re-entered.  The Perio-Imager contains its own liquid reservoir so it can be used in locations without a water supply.

The Complete System

Hand Piece - Assembled

Figure 3

Hand Piece - Dis-assembled

Figure 4

The Perio-Imager is capable of… Periodontal Measurement

Figure 5

The Perio-Imager is capable of… Charting Results

Figure 6

The Perio-Imager is capable of… Patient Management

Figure 7

FDA Approval: The Perio-Imager is expected to be approved by the FDA and available for sale in the last quarter of 2009.