Table 18 Characteristics of the study of Shankland [16, 18]

Shankland [16, 18]

Randomized controlled clinical trial

To evaluate the safety and effectiveness of the NTI-tss device for the reduction of frequency and severity of tension-type and migraine headaches.

Not reported

1. Diagnosis of tension-type or migraine headaches

Presence of TMDs

94 (average age and range: not reported)

NTI-tss device (n = 51) vs. full-coverage occlusal splint without cuspid rise and anterior guidance (similar to a bleaching tray) (n = 43) worn at night and during the day when perceiving stressful periodes

2. Intake of Sumatriptan as a rescue medication

3. 3. Having experienced an average of two migraine episodes or 8 tension-type headaches per month

4. Presence of natural or fixed prosthetic maxillary and natural mandibular incisors

5. Overbite and overjet within normal limits

6. Stable dentition with no current orthodontic treatment and fully erupted teeth

7. No significant periodontal disease

8. No TMD signs and/or symptoms

9. At least 18 years of age

Study

Study duration

Outcome parameters

Results

Authors' conclusions

Shankland [16, 18]

4 weeks baeline data + 8 weeks therapy

(A) Clinical objective outcomes:

Within-treatment-group pre-post differences

1. "The NTI-tss appliance proved safe and efficacious in the reduction of medically diagnosed migraine and tension-type headache."

- Interocclusal record

NTI-tss group:

- Tooth mobility of all anterior teeth

- 16% of the participants reported an 85% to 100% reduction of migraine headaches

- Tooth sensibility of the anterior teeth (temperature, pressure)

Users reported an elimination of 46.9% of all headache pain as well as reduction of photophobia, phonophobia and nausea

- Periodontal health of all teeth

Control group:

- Periapical radiographs of the anterior teeth

- 7% of the subjects reported a 85% to 100% reduction of migraine headaches

- Vitality of the anterior teeth

- 27% of the subjects reported an average 46% increase in migraine events

- Tenderness of the head and neck muscles

- Increase of migraine frequency

- Trigger points

Between-groups post-treatment differences

- Range of mandibular motion

- In every category (headache episodes, dosages of rescue medicine (Imitrex^®), phonophobia, photophobia, nausea), the percentage of reduction of all symptoms decreased for those in the NTI-tss group.

- TMJ noises

- TMJ tenderness

- Tension-type headache

- Migraine headache

- Nausea

- Photophobia

- Phonophobia

- Analgesics taken (and doses)

- Use of rescue medicine (Sumatriptan^®)

(B) Clinical subjective outcomes (VAS):

- Intensity of tension-type headache

- Intensity of migraine