To date CerezenTM devices has been evaluated in a number of studies including a three month, prospective, open-label, three-arm, randomized clinical trial, in North America. More recently we have interim six month results from a 12 month case series evaluation being conducted at the Birmingham Dental Hospital in the UK.
CerezenTM devices is a completely reversible treatment with few contra-indications, and has been shown to have a high compliance and satisfaction rate compared to intra-oral appliances. All studies completed to date have shown significant improvement in pain scores. Anxiety and depression scores, measured by HAD anxiety and depression questionnaires, also improved.
Note: the indication for CerezenTM devices use in European territories is different to the US approved use. The approved indication in the US is as an “aid in reducing temporomandibular disorder (TMJD) pain”. The approved indication in Europe is for the “treatment of pain and associated symptoms of TMJD”.
3 Month Study
Earlier randomized clinical trial
152 subjects were enrolled in the study and randomized into three study arms as follows: CerezenTM devices, n=60; 52 completed study bite splint, n=64; 56 completed study exercise, n=28; 22 completed study
Results from the three month study
- The three treatment groups were treated with CerezenTM devices, stabilization splints or jaw exercise regimens
- Patients in the CerezenTM devices cohort wore the devices for an average of 18-21 hours per day during the clinical study
- All of the subjects in the CerezenTM devices study arm indicated excellent (71%) or good (29%) overall satisfaction with the devices
- The CerezenTM devices study participants reported:
- Greatest reduction (i.e. symptom improvement) in the mean craniomandibular index (CMI) from baseline over all other patient cohorts at all study intervals
- Greatest decrease in pain as assessed by the Visual Analog Score (VAS) for pain over all other patient cohorts at all study intervals
6 Month Study
Six month data from ongoing study underway in Birmingham Dental Hospital, UK*
Interim results at six months
- 81% found devices very or moderately helpful in treating their TMJD symptoms
- ‘Very Helpful’ (56%)
- ‘Moderately Helpful’ (25%)
- OHIP (Oral Health Impact Profile), OBC (Oral Behavioral Checklist), VAS (Visual Analog Pain Score) Headaches, jaw clicking and jaw opening all improved at 6 months
- No major adverse events over the course of the study
For a summary of studies completed to date, please go to CerezenTM Devices Study Summary.
*At the six month point, interim results are available for 14 of the original 18 participants. Two patients did not wear the device at all and were not available for recall at the three month point. Two further patients attended for their three month review but have so far not been available to attend for the six month review. Individual cases where data has been generated beyond six months have indicated sustained improvements, and in some cases, further improvement.
Select case studies on patients treated with CerezenTM devices
A 52 year old female patient diagnosed with pain associated with Temporomandibular Joint Disorder (TMJD)
30 year old male professional presented with a history of headaches since his late teens. He was diagnosed with TMJD headaches