Studies

Use of Mintiva TMJ Topical Cream for Treatment of Temporomandibular Joint and Muscle Pain in Symptomatic Patients

Read the original article, published in the Journal of the American Academy of Craniofacial Pain, as a PDF by clicking here.

ABSTRACT: 

Eighty consecutive patients with the primary complaint of Temporomandibular Joint (TMJ) pain were enrolled in a study to assess their response to interceptive provisional treatment between the time of their initial examination and the onset of their planned definitive treatment. Ten patients (12%) received no provisional treatment; eighteen patients (23%) received a mandibular soft splint cut away with a raised area over the first molar to be a soft pivot splint referred to as a pain release splint; and fifty-two patients (65%) received a topical pain relieving cream, MINTIVA TMJ™. These individuals were then sub-divided into whether they had TMJ pain only, TMJ pain and otalgia, TMJ pain and swelling, TMJ pain and decreased range of motion (ROM) or TMJ pain, otalgia and decreased range of motion. Upon their return to the office to begin definitive treatment, their response to the provisional care protocols was evaluated. The ten patients (12%) who received no treatment had no improvement in their symptoms and some had worsened.

Eighteen (18) patients, or 23% of the total study population, received a pain release splint. Of this population, 28% reported no response. Among the 72% who did report relief of symptoms, results were evenly divided among mild, moderate and significant.Fifty-two (52) patients, or 65% of the total study population, received the topical cream, MINTIVA TMJ™. Of this population, two (2) patients (3%) did not use it and five (5) patients (10%) reported no relief. The remaining 87% of the patients using MINTIVA TMJ™reported results that were almost evenly divided among mild (31%), moderate (33%) and significant (23%).

The advantage of the home applied cream was no in-office treatment time. 87% of the patients with the MINTIVA TMJ™ saw a clinically significant response to the application where the patients with the fabricated splint requiring impression technique, fabrication and insertion received 72% improvement. The advantage of this topical for immediate treatment of symptomatic patients was a greater degree of relief was provided by the MINTIVA TMJ™ with the least clinical time spent to achieve the response.

MATERIALS and METHODS:

Consecutive patients seeking treatment for temporomandibular joint (TMJ) pain were included in the study. Criteria for participation in this study included:

1. Temporomandibular joint (pre-aricular pain) by history and examination as a primary complaint.

2. Completion of the TMJ Scale® confirming temporomandibular joint pain.

The TMJ Scale® is a 97-question inventory that is a quantitative and qualitative analysis of patient symptoms. Published studies have shown the validity, reliability, sensitivity, and specificity of the TMJ Scale®.

3. Informed consent agreement to proceed into more definitive treatment and acceptance of the provisional care offered.

Each patient’s initial visit was composed of obtaining the complete medical and dental history and listing chief complaints in their order of importance, full clinical evaluation of the head, neck and facial area, including the entire masticatory system, review of proposed treatments, financial arrangements, and informed consent.

Each patient was subsequently evaluated with cone beam CT imaging including panoramic, cephalometric and temporomandibular joint studies. Facial and intra-oral photographs were taken and orthodontic type study models, as well as working models, and occlusal registrations were captured.

The patients were instructed to use MINTIVA TMJ™ twice daily, ideally the first thing of a morning and prior to retiring to bed. They were instructed to use it one or two other times throughout the day, if they chose to do so. There were variable usages that were difficult to identify as the number of applications by the patients varied from 2-4 times daily for the approximate one week between appointments.

RESULTS:

Ten (10) patients (12%) were provided no provisional treatment between the initial evaluation, diagnostic records and the beginning of definitive treatment. This group will serve as a control group to see if symptoms resolved between visits without any interceptive care. Of those ten patients, none reported any improvement in symptoms.

Eighteen (18) patients (23%) received the mandibular soft pivotal pain release splint. These patients were divided almost equally in their responses. Five (5) patients (28%) of those with the splint reported no response. Five (5) patients (28%) reported a mild response to the use of the device. Four (4) patients (22%) reported moderate improvement in their TMJ pain related symptoms. Four (4) patients (22%) reported significant improvement in their symptoms.

Fifty-two (52) patients (65%) of the total study population were provided the topical pain relieving cream, MINTIVA TMJ™. Two (2) patients (3%) did not use the topical, though it was provided. Both of these patients, for their own various reasons, chose not to use the cream because they didn’t think it would help and chose to wait for the more definitive treatment.

Five (5) patients (10%) showed no response to the use of the topical. Sixteen (16) patients (31%) noted a mild response but deemed clinically valuable by the patient. Seventeen (17) patients (33%) had a moderate response and twelve (12) patients (23%) reported a significant response. Therefore, eighty-seven percent (87%) of the patients using MINTIVA TMJ™ reported a clinically significant response to its application.

The group of 52 patients that used the topical pain relieving cream MINTIVA TMJ™ were further broken down into sub-categories of TMJ pain, TMJ pain and otalgia, TMJ and swelling, TMJ and decreased range of motion (ROM), and TMJ, oralgia, and decreased range of motion. Twenty-nine of the 52 patients (56%) had TMJ pain as their singular complaint within this spectrum of complaints related to their joints. Two of the 29 (7%) reported no response whatsoever, 11 (38%) noted a mild response, 6 (21%) reported a moderate response and 8 (28%) noted a significant response and 2 did not use the cream.

Of those patients with TMJ pain and otalgia, there were 11 patients (%) with one patient having no response, 2 with a mild response, 4 with a moderate response and 4 with a significant response.

Of the four patients with TMJ pain and clinically evident swelling, 1 patient noted no response, 1 noted a mild response and 2 noted a moderate response. Six patients presented with TMJ pain and decreased range of motion (ROM). One patient noted no response, 1 noted a mild response and 4 reported a moderate response.

The last group of those patients to use the topical application, there were 2 patients who noted TMJ, Otalgia and decreased range of motion. One patient noted a mild response and the other had a moderate response.

DISCUSSION:

Is provisional treatment beneficial to the patient whose chief complaint is temporomandibular joint pain?

YES. Of the eighty (80) patients in this study, 72.5% (i.e., 13 using splint + 45 using MINTIVA TMJ™) reported positive improvement in relief of symptoms as a result of provisional, interceptive treatment initiated between the time of their initial examination and the onset of their planned definitive treatment.

By comparison twenty-two (22) patients, or 27.5% (i.e., 10 no tx + 5 using splint + 5 using MINTIVA TMJ™ + 2 who did not useMINTIVA TMJ™) of the population – including those who received no provisional treatment as well as those who declined to use the prescribed provisional treatment – reported no improvement. Of these patients, none actually reported a worsening of their symptoms in the period between the initial examination and the onset of definitive treatment.

Which provisional, interceptive treatment resulted in the greatest numbers of patients reporting relief of their symptoms, the soft pain release splint or the MINTIVA TMJ™ cream?

MINTIVA TMJ™. 90% (i.e., 45/50 patients) in this study who used MINTIVA TMJ™ cream – reported improvement in their symptoms.

By comparison, only 72% (i.e., 13/18 patients) in this study who used the soft pain release splint reported improvement in their symptoms between their initial visit and the onset of definitive treatment.

Which achieved the greatest degree of symptom relief, the soft pain release splint or MINTIVA TMJ™? In other words, which provisional treatment was the most efficacious?
Use of MINTIVA TMJ™ and a pain release splint appear to be equally efficacious, as indicated in the table below. However, it merits mention that nearly 3x as many patients for whom a pain release splint was prescribed as an interceptive, provisional treatment reported no relief of their symptoms vs. the patients who used MINTIVA TMJ™.

	No Relief	Mild	Moderate	Significant
Pain-Release Splint	28%	28%	22%	22%
MINTIVA TMJ™	10%	31%	33%	23%

 

Based on this study, what symptoms appear to respond best to MINTIVA TMJ™ cream?

Preliminary data suggests that use of MINTIVA TMJ™ will benefit the overwhelming majority of patients who present with chief complaints of:

a) TMJ pain only (92.6%)

b) TMJ pain and Otalgia (91%); and,

c) TMJ pain and decreased Range of Motion (ROM) (83%).

The data is somewhat less conclusive with regard to the benefits to be gained from the use of MINTIVA TMJ™ by patients whose chief complaints are a) TMJ pain and swelling or b) TMJ pain, otalgia and decreased Range of Motion (ROM). Approximately 50% of the patients in these classifications reported significant reduction in symptoms following the use of MINTIVA TMJ™.

Clearly, provisional treatment in the period between initial examination and the onset of definitive treatment does benefit the majority of patients seen in clinical practice. Preliminary data suggests that pain release splints and MINTIVA TMJ™ are efficacious when used as interceptive, provisional treatments. However, a slightly higher overall percentage of patients using MINTIVA TMJ™ reported mild to moderate improvement vs. those using the pain release splint – that is, 64% vs. 50% respectively.

Data from this study also appears to suggest that the efficacy of MINTIVA TMJ™ may be equal to or greater than soft pain release splints in terms of providing patients with immediate relief of temporomandibular joint pain. Moreover, only 10% of patients who usedMINTIVA TMJ™ reported no relief of symptoms. This is nearly 3x fewer than the number patients who used a pain release splint yet reported no clinically-significant results.

Eighty-seven percent (87%) of all patients in this study who used MINTIVA TMJ™ reported clinically significant relief of TMJ pain. However, given the relatively small sample size of patients with differing chief complaints, further research is required to determine with certainty what types of patients are optimal candidates for MINTIVA TMJ™ vs. other provisional treatments.

Evaluation of the cost savings to patients and clinicians as a consequence of the use of MINTIVA TMJ™ vs. soft pain release splints is also a factor that may merit consideration in provisional treatment decision-making.

CONCLUSION:

Eighty consecutive patients were selected for the study with primary complaints of temporomandibular joint pain. Ten of the patients (12%) were not given the provisional treatment before initiating their definitive treatment and none of those patients saw a symptom change between appointments other than symptoms being slightly worse. Eighteen patients (23%) were provided were provided with the custom constructed lower mandibular soft pivotal pain release splint and 72% of those patients derived a benefit. Fifty-two patients (65%) utilized the topical pain relieving cream MINTIVA TMJ™ and 87% noted clinical improvement almost equally distributed between mild, moderate and significant.

The ease and clinically efficacy of the topical cream for a provisional and/or supplemental treatment during definitive care shows great efficacy and improved clinical outcomes for the patients involved.

REFERENCES:

Pain Resource Center, Durham, North Carolina.

Lundeen TF, Levitt SR, McKinney MW. Clinical Application of the TMJ Scale, J Craniomandib Pract 1988, 6 339-345.

Levitt SR, McKinney MW, Lundeen TF. The TMJ Scale Cross Validation and Reliability Studies, J Craniomandib Pract 1988, 6 17-25.

Levitt SR. Predictive value of the TMJ Scale in Detecting Clinically Significant Symptoms of Temporomandibular Disorders. J Craniomandib Disorder, Facial, Oral Pain 1990, 4 177-185.

Levitt SR, McKinney MW. Validating the TMJ Scale in a National Sample of 10,000 Patients. J Orofacial Pain 1994, 8 25-35.

Levitt SR, McKinney MW. Appropriate Use of Predictive Values in Clinical Decision Making and Evaluating Diagnostic Tests for TMD. J Orofacial Pain 1994, 8 298-308.