Before OraChill, there was GUMEASE. GumEase was the pioneer oral cryotherapy device that evolved into what OraChill is today...
GumEase PRODUCT TESTING 2007
Following is a summary of findings resulting from testing conducted to ensure the efficacy of use of the GumEase® cryodevice in the patient-practitioner environment. Also included in the case study videos from GumEase conducted in 2007 by Biomedevices LTD when GumEase was marketed as a "stand alone" alturnative traditional dental anesthesia. NOTE: OraChill is NOT sold as a dental anesthesia alturnative. The following data is published to demonstrate efficacy claims of cryoanethesia.
Potential participants in these tests were selected at random from the bed and 10 scheduled/unscheduled patients in the investigating practitioner's office. A primary goal of course was to test the device on individuals who would not use any injected anesthesia and candidates were queried accordingly. The scope of the trial and the use of the GumEase® were described in detail to each testing candidate (an interpreter was used in all cases where language might present a barrier to complete understanding)
As part of the interview process, the patient's preoperative level of pain and discomfort was assessed by use of the visual analog scale (VAS) from 1 to 10. Each patient was also told that they would be asked to assess the level of pain during the procedure and postoperatively in that rescue drugs were available if they required them. In this manner the requisite number of 40 patients consented and were accepted to participate in the gumEase tests.
REASONS FOR PATIENTS TO SEEK TREATMENT
Listed below are the reasons given by the trial participants for seeking treatment by the investigating practitioner and associated percentages of the study group requiring treatment for each category. NOTE: some participants listed multiple causes for treatment.
1. Bridge preparation including cutting/repair 10%
2. Endodontia 5%
3. Caries repair 25%
4. Extraction (including wisdom teeth) 10%
5. General cleaning (calculus debridement) 15%
6. Deep cleaning (root planing, scaling) 20%
7. Suture removal 10%
8. Intense/severe pain 40%
9. Heart problems, sensitivity to epinephrine 10%