1. Does DIAGNOdent aid in the diagnosis of pit & fissure caries?
2. What is the clinical value of DIAGNOdent?
B. STEP-BY-STEP PROCEDURES FOR DIAGNODENT CLINICAL EVALUATION
1. By clinical examination, a chart was completed
of locations on teeth having suspected caries.
2. A dentist was asked to treat (excavate & restore) two teeth having suspected
caries in pits and fissures.
3. Four bite wing radiographs were made. Diagnosis by the dentist was recorded.
4. The dentist was asked if he would treat selected suspect teeth using the
standard diagnostic methods available today (radiographs, visual inspection,
explorer inspection). The dentist’s answer was recorded by tooth number and
site location. Other comments made by the dentist were also recorded (i.e. color
& size of pit and/or fissure, explorer stick, if area of stain was evident on
radiograph, etc.).
5. The dentist & patient determined course of action and local anesthetic was
administered, if determined necessary. 6. Teeth to be treated received a standard
prophylaxis.
7. Initial clinical photographs were made of teeth to be treated.
8. The dentist was instructed on step-by-step calibration and use of the DIAGNOdent.
DIAGNOdent measurements were made and recorded using tip “A” (occlusal sites
only).
9. After the dentist removed the first layer of stain, clinical photographs
were made to show what was directly under the initial layer of stain.
10. Treatment resumed and the dentist completed the prep. Caries detection dye
was used to confirm removal of all carious material.
11. A specially designed depth measurement instrument (made for CRA by Nordent)
was used to determine depth of each final prep (millimeters).
12. Teeth were restored using materials and procedures at the dentist’s & patient's
discretion.
C. Evaluation in 33 Clinical Dental Offices
1. Eleven clinicians who owned the DIAGNOdent were
asked to complete an evaluation form.
2. Twenty two clinicians who used DIAGNOdent instruments on loan to CRA for
the evaluation from the company were asked to complete an evaluation form to
assess clinical usefulness in their private dental office settings.
D. DATA ANALYSIS
1. Data from DIAGNOdent readings vs. depth measurements
were analyzed to determine any clinical or statistical correlations (Pearson's
correlation).
2. Compilation of field evaluation forms to calculate an overall ranking by
evaluators.