Migraine treatment comparing NTI and a full occlusal splint for the FDA

This study on the treatment of migraine and tension headache was conducted for and under the direct supervision the USA’s Food and Drug Administration on the NTI device, or Nociceptive Trigeminal Inhibition Tension Suppression System, for the treatment of migraine and tension-type headache.

The NTI is an occlusal splint/ bite guard that fits between the teeth and is effective in the treatment of migraine and tension headache. It works by reducing bruxism (grinding of the teeth) and relaxing the jaw muscles while the patient is sleeping.

The US Food and Drug Administration set out the section criteria for patients which included both migraine and tension-type headache sufferers, use of sumatriptan as an abortive medication. Sumatriptan is a vaso-constrictor so for the NTI to be effective in these patients was a very high bar for the FDA to set for a dental device that fits in the mouth. Patients in the study were then evaluated for muscle tenderness in all the muscles of the head face and neck and all tender trigger points recorded.

The baseline period for the study was four weeks. This means that researchers gather data about the patient’s headaches and migraines for four weeks before any treatment began. They measured pain intensity and frequency, medication intake, and use of sumatriptan as rescue medication.

Ninety-four patients participated in the treatment phase. Fifty-one were treated with the NTI device ad forty-three were treated with a full occlusal splint. The full occlusal splint was an intelligent control group to use as data for its efficacy in treating headache and migraine had already been collected by previous researchers and shown it to be about forty percent effective.

The study’s control group thereby tested the NTI against the next best known occlusal splint for migraine and headache, and at the same time served to confirm the results that had been reported in full occlusal splint.

The treatment phase lasted eight weeks and the NTI device was shown to be approximately twice as effective in the treatment of migraine and tension-type headache than a full occlusal splint. The results of the control group treated with a full occlusal splint confirmed the previous migraine and headache treatment study’s data.

View the original migraine study at this link: Migraine and Tension-Type Headache Reduction Through Pericranial Muscular Suppression: A Preliminary Report

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