Clinical

Results

To date the Cerezen device has been evaluated in a number of studies including a three month, prospective, open-label, three-arm, randomised clinical trial. 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.

Cerezen 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, reduction in clenching and grinding of teeth, headache improvement and also significant improvements in ability of patients to open their jaws. Anxiety and depression scores measured by HAD anxiety and depression questionnaires were also improved.

3 Month Study


Earlier Randomised Clinical Trial

Study Details

152 subjects were enrolled in the study and randomised into three study arms as follows:

Cerezen 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 Cerezen devices, stabilisation splints or jaw exercise regimens
  • Patients in the Cerezen device cohort wore the devices for an average of 18-21 hours per day during the clinical study
  • All of the subjects in the Cerezen device study arm indicated excellent (71%) or good (29%) overall satisfaction with the device
  • The Cerezen 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 TMD symptoms
    • ‘Very Helpful’ (56%)
    • ‘Moderately Helpful’ (25%)
  • OHIP (Oral Health Impact Profile), OBC (Oral Behavioural 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 Cerezen 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 results, and in some cases, further improvement.

Select Case Studies on Patients Treated with Cerezen

A 52 year old female patient diagnosed with pain associated with Temporomandibular Disorder (TMD)

41 year old female presenting with an Anterior Disc Displacement without Reduction.

Two month Report on Cerezen use for a 35 year old female presenting with Anterior Disc Displacement without Reduction, Myalgia and Arthralgia

30 year old male professional presented with a history of headaches since his late teens. He was diagnosed with TMD headaches

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If you’re interested in providing Cerezen to your TMD patients, click on the link below to find out more details of how easy it is to get started

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