Armor Dental Summary Report
|NAME OF SPONSOR: Armor Dental Corporation
NAME OF FINISHED PRODUCT: Mouth•Mate
|Title of Study||In-Office Study to determine the clinical utility of Mouth•Mate.|
|Investigator(s)||Dr. Katherine Haltom, Dr. Lawrence Joyce|
|Study Center(s)||Dr. Katherine Haltom
223 Walnut St Suite 2, Framingham, MA 01702
Dr. Lawrence Joyce
689 Fellsway, Medford, MA 02155
|Study Period||From: January 5, 2015 – March 27, 2015||Phase of development: Pilot Clinical Study|
|Objectives||Primary Objective: To determine if the current Mouth•Mate design meets the needs of the end-user during post-surgery at home oral care.
Secondary Objective: To determine if end-user is compliant with the clinician’s recommendation to use the product at home and thought the product helped them.
|Methodology||To determine the primary and secondary objectives of this pilot clinical study surgical cases, including cases of tooth extraction (impacted and non-impacted), bone grafting prior to implant placement, implant placement, tooth exposure, frenectomy, biopsies and tongue surgeries were selected by the clinician prior to the surgical procedures. Patients were asked if they wanted to participate in the pilot study prior to their surgery. After the surgical procedure and during the discussion of post-surgical oral care at home the patient was introduced to the Mouth•Mate product and given instructions of how to use the product. The features and benefits of the product were explained to the patients and the patient was asked to use the product during the period after the initial procedure was completed and until the patient was recalled for their follow up visit typically 7-10 days post-surgery. During the recall visit the patient was asked the following questions and to rate their answers on a scale of 1-5 with 5 being the highest rating for each question:
1. Did you use the product as instructed? (Yes or No)
2. How long did you use the product? (Number of days)
3. Was the product easy to use? (1-5)
4. Did the shield fit over the surgical site well?(1-5)
5. Did contacting the surgical site with the shield cause any pain or discomfort? (1-5)
6. Was the use of Mouth•Mate a comfortable experience? (1-5)
7. Would you recommend Mouth•Mate to a friend? (1-5)
|Number of patients||Planned: 100
EFFICACY RESULTS: BASED ON A SCALE OF 0 (Poor) – 5 (Excellent).
SAFETY RESULTS: No adverse events were reported during the conduct of this pilot clinical study. No patient complaints were reported during the conduct of this pilot in-office study.
CONCLUSION: The pilot clinical data from this study suggest that the design of the Mouth•Mate product was east to use, effective and meet the end user’s needs with over 92% of the subjects willing to recommend to a friend.
DATE OF THE REPORT: April 1, 2015
Why dental professionals should consider Mouth•Mate:
A clean mouth is the hallmark of oral wellness. Mouth•Mate addresses an unmet need in at-home hygiene easily and without pain.
There are over 210,000 dental offices in the United States alone and many of these offices average low to high infection rates. The national post-surgical infection rate is 5%-8% and Armor Dental’s main goal with Mouth•Mate is to improve patient behaviors at home during recovery so long-term outcomes improve . Patients using Mouth•Mate while brushing normally after a procedure are able to keep their mouths clean, protect the surgical site from complications and decrease inflammation, infections and pain.
Up to 15% of patients call or return for unscheduled appointments due to pain or infection. Patients using Mouth•Mate make less calls to the office on benign post-surgical care questions and need fewer post-operative appointments. That translates to a reduction in office calls and unscheduled, non-billable appointments – improving office efficiency and cost containment.