Clinical

Results

To date CerezenTM treatment 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 treatment 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 device 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

Study Details

152 subjects were enrolled in the study and randomized into three study arms as follows: CerezenTM device, 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 treatment cohort wore the devices for an average of 18-21 hours per day during the clinical study
  • All of the subjects in the CerezenTM device study arm indicated excellent (71%) or good (29%) overall satisfaction with the device
  • The CerezenTM  device 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 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

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

Find out more

To find out more about how this product can help your patients, contact us at 855-303-4601 or customerservice@cerezen.com

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