Frequently Asked Questions
View answers to some of the most frequently asked questions about becoming a Cerezen™ inserts prescriber, below...
- Cerezen™ inserts are a pair of prosthetic devices that are placed in each of the ear canals. They aid in reducing pain associated with temporomandibular joint disorder (TMJD)
- The inserts conform to the shape of the ear canal when the jaw is in an open position
- The ear inserts for TMJ have central hollow passageways so there is no interference with hearing
- each ear insert supports the TMJ [Temporomandibular joint] and associated secondary musculature to generally reduce strain in the TMJ area and
- the inserts provide “cognitive awareness” (consciously or subconsciously) to the wearer regarding para-functional habits (e.g., jaw clenching) that contribute to TMJ pain relieving strain in the TMJ area. Both mechanisms function because of the proximity of the ear canal to the TMJ, and that the ear inserts maintain the shape and volume of the ear canal as the jaw opens and closes. As can be seen in the figure to the right, the ear canal (external auditory meatus) is located immediately posterior to the condyle and disc of the TMJ.
A clinical trial of Cerezen™ inserts (formerly known as the CID) was a prospective, open-label, three-arm, randomized, and un-blinded clinical trial with a pre-treatment screening phase, baseline visit and three-month treatment phase. The objective of the trial was to characterize the safety profile and assess the effectiveness of the inserts in treating subjects with temporomandibular joint disorders. Two comparison treatment groups were incorporated into the study, one with patients wearing an intraoral stabilization splint (bite splint), and the other with patients implementing a jaw exercise regimen. There were 60 patients in the Cerezen™ inserts group, 64 in the stabilization splint group, and 28 in the jaw exercise regimen group. Subjects enrolled in the study were those who met the inclusion criteria of having an RDC/TMJD diagnoses that included at least one of the following: myofascial pain; arthralgia, or disc displacement with reduction; and a screening VAS pain score of >4. The distribution of these RDC/TMJ disorder diagnoses was very similar in all 3 treatment groups: I: Myofascial Pain (97-100%); II-a: Disc Displacement with Reduction (45-48%); and III-a: Arthralgia (55-61%). The instruments used to assess TMJD in this study included the Craniomandibular Index (CMI-RDC), the Symptom Severity Index (SSI), the VAS (Visual Analog Scale for pain), and the TMJ Scale™. Following a one-month baseline evaluation period, patients initiated TMJ treatment and were followed for 3 months, with follow-up visits and data collection occurring at 1, 2, and 3 months. The primary efficacy endpoint was non-inferiority of the Cerezen™ inserts to the stabilization splint in the reduction of the Craniomandibular Index (CMI) score from baseline to 3 months. The primary safety endpoint was to characterize the safety profile of the Cerezen™ inserts by collecting and reporting study-related adverse events. With respect to statistical methods, the null hypotheses for primary effectiveness was that use of Cerezen™ inserts results in a reduction in CMI score of less than 80% of the reduction in score with the stabilization splint. The statistic used to test the null hypothesis of inferiority1 was compared to the Student’s t distribution withn-2 degrees of freedom, at a significance level of α = 0.05.
* TMJ Scale™ is a trademark of the Pain Resource Center, Inc
With respect to the primary efficacy endpoint, the Cerezen™ inserts demonstrated statistically significant non-inferiority to the stabilization splint in the reduction of the CMI score from baseline to 3 months (p=0.0096). Statistically significant reductions from baseline in TMJ pain, as assessed by in-office VAS (visual analog scale) scores, were also demonstrated for the Cerezen™ inserts (see Figure below), with a 46% reduction at 1 month (p<0.0001), 51% reduction at 2 months (p<0.0001), and a 58% reduction at 3 months (p<0.0001). Such results supported the label claim for the Cerezen™ ear canal inserts as being "indicated as an aid in reducing temporomandibular joint disorder (TMJD) pain."
* Tavera A, et al: Approaching Temporomandibular Disorders From a New Direction: A Randomized Controlled Clinical Trial of the TMDes Ear System. J Craniomandibular Practice July 2012; Vol 30, No. 3, 172-181
Patient global satisfaction in the pivotal clinical trial was extremely high, with 100% of subjects in the Cerezen™ inserts group indicating excellent (71%) or good (29%) overall satisfaction with the devices. In summary, in the pivotal clinical trial, Cerezen™ inserts demonstrated comparable efficacy and safety to the stabilization splint, a recognized standard of care and the most widely used current treatment for TMJD.
Patient global satisfaction in the pivotal clinical trial was extremely high, with 100% of subjects in the Cerezen™ inserts group indicating excellent (71%) or good (29%) overall satisfaction with the devices.
A Randomized Controlled Clinical Trial of the TMDes* Ear System.
J Craniomandibular Practice July 2012; Vol 30, No 3, 172-182. *TMDes is now called Cerezen™ inserts.
No significant complications have been reported. This is not unexpected, because the device is a pair of small, hollow, ear inserts made of medical grade polymers that are custom-fit to each patient’s ear canal, and are constructed from polymers and plastics that have been safely used in commercially available hearing aids for decades. The clinical trial of the Cerezen™ inserts did include evaluation of patients for a range of potential complications. There were no unanticipated adverse device effects or serious adverse events reported during the pivotal clinical trial. No study patients were found to have ear drainage, allergic reactions, swelling or changes to the mouth, ear or jaw at any of the follow-up visits. There were no reports of diminished hearing acuity in patients treated with Cerezen™ inserts.Tavera A, et al: Approaching Temporomandibular Disorders From a New Direction.
A Randomized Controlled Clinical Trial of the TMDes* Ear System.
J Craniomandibular Practice July 2012; Vol 30, No 3, 172-182. *TMDes is now called Cerezen™ inserts
No. Each of the TMJ ear canal inserts are custom fit and manufactured for each patient.
The right ear insert is marked with a red dot, while the left insert is marked with a blue dot.
Yes. However, if a patient experiences discomfort, they should remove the inserts. Prescribers should refer to the Cerezen™ Precautions page for a complete list of warnings and precautions.