Background
Methods
Identification of publications about the efficacy and/or effectiveness of the NTI-tss device
# | Search terms | Hits | Relevant hits | Cumulative relevant hits | Reference |
---|---|---|---|---|---|
1 | NTI | 10 | 2 | 2 | |
2 | NTI-tss | 0 | |||
3 | NTI* | Cochrane reviews: 11 | 0 | ||
clinical trials: 37 | 2 | 2 | |||
methodological studies: 2 | 0 | ||||
economic evaluation: 1 | 0 | ||||
4 | nociceptive trigeminal inhibition | 5 | 4 | 5 | |
5 | nociceptiv* trigeminal inhibition | 6 | 5 | 5 | |
6 | anterior deprogrammer | 0 |
# | Search terms | Hits | Relevant hits | Cumulative relevant hits | (New) Relevant references |
---|---|---|---|---|---|
1 | NTI | 195 | 7 | 7 | |
2 | NTI-tss | 0 | |||
3 | NTI* | 355 | 7 | 7 | |
4 | nociceptive trigeminal inhibition | 107 | 4 | 10 | |
5 | nociceptiv* trigeminal inhibition | 108 | 5 | 10 | |
6 | anterior deprogrammer | 2 | 0 | ||
7 | "Temporomandibular Joint Disorders"[MeSH] AND NTI | 7 | 7 | 10 | |
8 | "Temporomandibular Joint Disorders"[MeSH] AND NTI-tss | 0 | |||
9 | "Temporomandibular Joint Dysfunction Syndrome"[MeSH] AND NTI | 0 | |||
10 | "Temporomandibular Joint Dysfunction Syndrome"[MeSH] AND NTI-tss | 0 | |||
Clinical queries; therapy, broad sensitive search:
| |||||
11 | (NTI) AND ((clinical [Title/Abstract] AND trial [Title/Abstract]) OR clinical trials [MeSH Terms] OR clinical trial [Publication Type] OR random* [Title/Abstract] OR random allocation [MeSH Terms] OR therapeutic use [MeSH Subheading]) | 42 | 4 | 10 | |
12 | (NTI-tss) AND ((clinical [Title/Abstract] AND trial [Title/Abstract]) OR clinical trials [MeSH Terms] OR clinical trial [Publication Type] OR random* [Title/Abstract] OR random allocation [MeSH Terms] OR therapeutic use [MeSH Subheading]) | 0 | |||
13 | (NTI*) AND ((clinical [Title/Abstract] AND trial [Title/Abstract]) OR clinical trials [MeSH Terms] OR clinical trial [Publication Type] OR random* [Title/Abstract] OR random allocation [MeSH Terms] OR therapeutic use [MeSH Subheading]) | 98 | 4 | 10 | |
14 | (Nociceptive trigeminal inhibition) AND ((clinical [Title/Abstract] AND trial [Title/Abstract]) OR clinical trials [MeSH Terms] OR clinical trial [Publication Type] OR random* [Title/Abstract] OR random allocation [MeSH Terms] OR therapeutic use [MeSH Subheading]) | 25 | 4 | 10 | |
15 | (Nociceptiv* trigeminal inhibition) AND ((clinical [Title/Abstract] AND trial [Title/Abstract]) OR clinical trials [MeSH Terms] OR clinical trial [Publication Type] OR random* [Title/Abstract] OR random allocation [MeSH Terms] OR therapeutic use [MeSH Subheading]) | 26 | 5 | 10 | |
16 | (Anterior deprogrammer) AND ((clinical [Title/Abstract] AND trial [Title/Abstract]) OR clinical trials [MeSH Terms] OR clinical trial [Publication Type] OR random* [Title/Abstract] OR random allocation [MeSH Terms] OR therapeutic use [MeSH Subheading]) | 0 |
# | Search terms | Hits | Relevant hits | Cumulative relevant hits | (New) Relevant references |
---|---|---|---|---|---|
1 | NTI |
evidence-based Synopses: 1 | 0 | ||
guidelines: 2 | 0 | ||||
clinical questions: 1 | 0 | ||||
E-textbooks: 1 | 0 | ||||
other: 1 | 0 | ||||
Medline:
| |||||
therapy: 9 | 3 | 3 | |||
diagnosis: 8 | 0 | ||||
systematic reviews: 4 | 0 | ||||
prognosis: 8 | 0 | ||||
etiology: 5 | 0 | ||||
2 | NTI-tss | 0 | 0 | 3 | |
3 | NTI* | systematic reviews: 207 | 0 | ||
evidence-based synopses: 17 | 0 | ||||
guidelines: 33 | 0 | ||||
clinical questions: 33 | 0 | ||||
E-textbooks:19 | 0 | ||||
More: 3 | 0 | ||||
Medline:
| |||||
therapy: 16 | 3 | 3 | |||
diagnosis: 11 | 0 | ||||
systematic reviews: 26 | 0 | ||||
prognosis: 16 | 0 | ||||
etiology: 15 | |||||
4 | nociceptive trigeminal inhibition | systematic reviews: 1 | 0 | ||
Guidelines: 3 | 0 | ||||
E-textbooks: 9 | 0 | ||||
Medline:
| |||||
therapy: 6 | 4 | 6 | |||
diagnosis: 2 | 0 | ||||
systematic reviews: 0 | |||||
prognosis: 1 | 0 | ||||
etiology: 0 | |||||
5 | nociceptiv* trigeminal inhibition | systematic reviews: 1 | 0 | ||
guidelines: 3 | 0 | ||||
E-textbooks:9 | 0 | ||||
Medline:
| |||||
therapy: 8 | 5 | 6 | |||
diagnosis: 2 | 0 | ||||
systematic reviews: 0 | 0 | ||||
prognosis: 1 | 0 | ||||
etiology: 0 | |||||
6 | anterior deprogrammer | 0 |
# | Search terms | Hits | Relevant hits | Cumulative relevant hits | (New) Relevant references |
---|---|---|---|---|---|
1 | NTI | All: 396 | |||
Medline: 357 | 7 | 7 | |||
in others 5 | 0 | ||||
2 | NTI-tss | 0 | |||
3 | NTI* | 825 Medline: 538 | (see PubMed search) | ||
4 | nociceptive trigeminal inhibition | 157 Medline: 156 | 4 | 10 | |
5 | nociceptiv* trigeminal inhibition | 157 Medline: 156 | 4 | 10 | |
6 | anterior deprogrammer | Medline: 4 | 0 | 10 |
# | Search terms | Hits | Relevant hits | Cumulative relevant hits | (New) Relevant references |
---|---|---|---|---|---|
1 | NTI |
General Health Sciences (190):
| |||
LILACS: 5 | 0 | ||||
Medline: 161 | (see PubMed search) | ||||
Cochrane Library: 23 | 0 | ||||
SciELO: 1 | 0 | ||||
Specialized Areas (1):
| |||||
BBO: 1 | 0 | ||||
International Agencies (1):
| |||||
WHOLIS: 1 | 0 | ||||
2 | NTI-tss | 0 | |||
3 | NTI* | 0 | |||
4 | nociceptive trigeminal inhibition |
General Health Sciences (114):
| |||
Medline: 102 | (see PubMed search) | ||||
Cochrane Library: 12 | 0 | ||||
5 | nociceptiv* trigeminal inhibition | 0 | |||
6 | anterior deprogrammer |
General Health Sciences (3):
| |||
LILACS: 1 | 0 | ||||
Medline: 2 | 0 |
# | Search terms | Hits |
---|---|---|
1 | NTI | 0 |
2 | NTI-tss | 0 |
3 | NTI* | 0 |
4 | nociceptive trigeminale Inhibition | 0 |
5 | nociceptiv* trigeminale Inhibition | 0 |
6 | anteriorer Deprogrammierer | 0 |
# | Search terms | Hits |
---|---|---|
1 | NTI | 3062 |
2 | NTI-tss | 0 |
3 | NTI* | 0 |
4 | nociceptive trigeminal inhibition | 0 |
5 | nociceptiv* trigeminal inhibition | 0 |
6 | anterior deprogrammer | 0 |
# | Search terms | Hits | Relevant hits | Cumulative relevant hits | (New) Relevant references |
---|---|---|---|---|---|
1 | NTI | about 95,000 | |||
2 | NTI-tss | 28 | 18 | 18 | |
3 | NTI* | 93,400 | |||
4 | nociceptive trigeminal inhibition | 8,760 | |||
5 | nociceptiv* trigeminal inhibition | 18 | 2 | 20 | |
6 | anterior deprogrammer | 37 | 2 | 20 |
Level | Description |
---|---|
I | Systematic review of randomized controlled trials (RCTs) |
II | Article about an RCT |
III | Article about an experimental study without randomization; cohort study; case-control-study |
IV | Article about a non-experimental study (cross-sectional study; case series; case report) |
V | Narrative review or expert opinion (based on clinical experience) without explicit clinical appraisal (e.g., statements, editorials; expert commentaries to published articles; interviews with experts, brief references to NTI-tss in articles; commercial-like reviews) |
Articles are assessed according to the following questions: |
---|
• Was the study described as randomized? |
• Was the study described as double blind? |
• Was there a description of withdrawals and dropouts? (The number and the reasons for withdrawal in each group must be stated. If there were no withdrawals, it should be stated in the article.) |
A score of 1 point is given for each "yes," a score of 0 points is given for each "no."
|
• One additional point is given if for question 1 the method to generate the sequence of randomization was described and it was appropriate (i.e., if it allowed each study participant to have the same chance of receiving each intervention and the investigators could not predict which treatment was next). |
• One additional point is given if for question 2 the method of double blinding was described and it was appropriate (i.e., if it is stated that neither the person doing the assessments nor the study participant could identify the intervention being assessed, or in the absence of such a statement the use of active placebos, identical placebos, or dummies is mentioned). |
• One point is deducted if for question 1 the method to generate the sequence of randomization was described and it was inappropriate (e.g., patients were allocated alternately). |
• One point is deducted if for question 2 the method of double-blinding was described and it was inappropriate. |
Identification of publications about complications and/or side effects of the NTI-tss device
Results
Overall yield of the search
Web link | Relevant hits | Cumulative relevant hits | Reference/Title |
---|---|---|---|
8 | 8 | ||
3 | 11 | ||
9 | 16 | ||
4 | 18 |
Qualitative analysis
Study | Study described as randomized? | Method described and appropriate? | Study described as blind? | Method described and appropriate? | Description of withdrawals/dropouts? | Jadad score |
---|---|---|---|---|---|---|
Baad-Hansen et al [22] | Yes | Not described | Yes | Yes | No withdrawals or dropouts | 4 |
Kavaklı [21] | Yes | Not described | No | --- | No withdrawals or dropouts | 2 |
Yes | Yes | Yes | Yes | Yes | 5 | |
Magnusson et al [9] | Yes | Yes | No | --- | Yes | 3 |
Yes | Not described | No | --- | No | 1 |
Contents-based analysis of the articles on RCTs
Study | Type of study | Aim of the study | Patient recruitment | Inclusion criteria | Exclusion criteria | n | Therapeutic comparison |
---|---|---|---|---|---|---|---|
Baad-Hansen et al [22] | Investigator-blinded randomized controlled cross-over trial | 1. To compare the therapeutic efficacy of two different intraoral devices on the EMG activity of bruxers during sleep. | Self-presentation of patients at the School of Dentistry, University of Aarhus (Denmark) | 1. Self-reported tooth-grinding during sleep, confirmed by bed-partner. | Use of any other medication than mild analgesics | 10 (average age: not reported; range: 23–39 years) | NTI-tss device (n = 10) vs. flat occlusal stabilization splint (OS) (n = 10) worn at night |
2. Reports of muscle soreness on awakening. | |||||||
3. Signs of tooth wear. | |||||||
2. To evaluate if changes in EMG activity are associated with short-term changes in TMD-related pain. | 4. TMD diagnosis by a blinded investigator according to the RDC/TMD [111]. | ||||||
Study
|
Study duration
|
Outcome parameters
|
Results
|
Authors' conclusions
| |||
Baad-Hansen et al [22] | 7–8 weeks | 1. "A strong and lasting inhibition of EMG activity in masseter muscles during sleep was caused by wearing the NTI splint but not the OS. However, this was not directly related to the short-term clinical outcome measures." |
Within-treatment-group pre-post differences
| "A strong and lasting inhibition of EMG activity in masseter muscles during sleep was caused by wearing the NTI splint but not the OS. However, this was not directly related to the short-term clinical outcome measures | |||
NTI-tss group:
| |||||||
- Significant decreases at all levels of EMG threshold during the use of the NTI-tss device when compared with baseline. | |||||||
OS group:
| |||||||
- No differences between the baseline EMG values for any of the EMG measures. | |||||||
Between-groups post-treatment differences
| |||||||
EMG outcomes: | |||||||
In contrast to the OS, the NTI-tss device was associated with significant decreases when compared with EMG baseline values. | |||||||
Clinical outcomes:
| |||||||
- No differences between the two therapies | |||||||
- No significant correlations between EMG data and clinical variables. |
Study | Type of study | Aim of the study | Patient recruitment | Inclusion criteria | Exclusion criteria | n | Therapeutic comparison |
---|---|---|---|---|---|---|---|
Kavaklı [21] | Randomized controlled trial | To compare the therapeutic efficacy of two different intraoral devices on the EMG activity of bruxers during sleep. | Self-presentation at the Hacettepe University Health Science Institute, Ankara (Turkey) | 1. Self-reported tooth clenching and tooth grinding for at least 6 month | 1. More than two missing molars | 20 (average age: 31 years; range: 14–52 years) | NTI-tss device (n = 11) vs. Michigan- type stabilization splint (SS) (n = 9) worn at night |
2. Grinding sounds during sleep for at least 3 nights per week as confirmed by bed-partner | 2. Removable prosthetic restoration | ||||||
3. Jaw muscle discomfort | 3. Gross malocclusion | ||||||
4. Abnormal tooth wear | 4. Constant use of sleep medication | ||||||
5. Masseter hypertrophy | 5. Abuse of alcohol and/or drugs | ||||||
6. Diagnosis of sleep bruxism in a sleep laboratory | 6. Neurological or psychological diseases | ||||||
7. Sleeping disorders | |||||||
8. Internal TMJ derangements as diagnosed with an MRI | |||||||
Study
|
Study duration
|
Outcome parameters
|
Results
|
Authors' conclusions
| |||
Kavaklı [21] | 4 months | (A) Sleep variables: |
Within-treatment-group pre- post differences
| 1. Both splint designs do not stop sleep bruxism activity as shown by polysomnographic evaluation. | |||
- sleep quality | |||||||
- total sleep time |
NTI-tss device:
| 2. The SS does not reduce the frequency, duration or intensity of the sleep bruxism. | |||||
- sleep efficiency | - no changes of other sleep parameters | 3. The NTI-tss device reduces the intensity of bruxism. | |||||
- sleep latency | - no changes of respiratory parameters | 4. Due to its positive effect on sleep bruxism and its easy adapatability, the NTI-tss device is recommended if regular check-ups by a dentist are possible. | |||||
- REM latency | - no changes in occlusion | ||||||
- percentages of stage duration | - reduced intensity of masseter and temporalis muscles contraction activities compared to baseline | ||||||
- number of awakenings during sleep | |||||||
- number of movements during sleep | |||||||
Stabilization splint:
| |||||||
(B) Respiratory variables: | - sleep stage 2 was shorter as compared to baseline | ||||||
- apnea | |||||||
- hypoapnea | - no changes of other sleep parameters | ||||||
(C) Bruxism-related variables as derived from masseter and temporal muscle activity: | - no changes of respiratory parameters | ||||||
- total bruxism duration | - no changes of sleep bruxism activity | ||||||
- number of bruxism episodes/night | |||||||
- number of bruxism episodes/h |
Between-groups post- treatment differences
No changes | ||||||
- number of bruxism burst/episode | |||||||
- number of bruxism burst/h | |||||||
- amplitude of bruxism episodes |
Study | Type of study | Aim of the study | Patient recruitment | Inclusion criteria | Exclusion criteria | n | Therapeutic comparison |
---|---|---|---|---|---|---|---|
Investigator-blinded randomized controlled trial | To compare the therapeutic efficacy of two different intraoral devices in TMD patients. | TMD patients referred to or applying for therapy at the Department of Prosthetic Dentistry and Stomatognathic Physiology, Faculty of Dentistry, University of Oslo (Norway) | Adults who had experienced TMD symptoms for at least 6 months, e.g., | 1. Partial protheses with distal extensions | 38 (average age: 37 years; range: 17–62 years) | NTI-tss device (n = 18) vs. Michigan-type stabilization splint (SS) (n = 20) | |
- impaired range of motion | 2. Additional TMD therapy during the trial | ||||||
- impaired TMJ function | 3. Recent facial or cervical trauma | worn at night | |||||
- muscle pain | |||||||
- TMJ pain | |||||||
- pain on mandibular movement | |||||||
Plus (both groups): | |||||||
1. counseling | |||||||
2. muscle relaxation exercises | |||||||
Study
|
Study duration
|
Outcome parameters
|
Results
|
Authors' conclusions
| |||
3 months | - Self-reported headache and TMD-related pain on a 100 mm VAS |
Within-treatment-group pre-post differences
| 1. The therapeutic efficacy between an NTI-tss device and a Michigan splint did not differ over an observation period of three months. | ||||
- Maximum unassisted jaw opening | - Average jaw opening increased in both groups | ||||||
- Tenderness on palpation of masticatory muscles, neck and shoulder muscles and TMJs on a 100 mm VAS | - VAS scores for TMD-related pain and self reported headache decreased significantly between baseline and 3-months examination in both groups | ||||||
- Reduction of jaw muscle (but not neck and shoulder muscles) tenderness upon palpation in both groups | |||||||
- No changes of TMJ tenderness upon palpation | |||||||
Between-groups post-treatment differences
| |||||||
- Comfort of splint use on a 100 mm VAS | - No differences between NTI-tss and SS groups at the 3-months examination | ||||||
- In both groups, the comfort of splint use appeared to be similar at each control examination with a (statistically not significant) trend of higher comfort for the NTI-device |
Study | Type of study | Aim of the study | Patient recruitment | Inclusion criteria | Exclusion criteria | n | Therapeutic comparison |
---|---|---|---|---|---|---|---|
Magnusson et al [9] | Investigator-blinded randomized controlled trial | To compare the therapeutic efficacy of two different intraoral devices in TMD patients. | Patients referred for suspected TMDs to the Department of Stomatognathic Physiology, the Institute for Postgraduate Dental Education, Jönköping (Sweden) | 1. TMD symptoms ≥ 6 months | 1. Ongoing TMD therapy | 28 (average age: 31.5 years; range: 16–70 years) | NTI-tss device (n = 14) vs. Michigan-type stabilization splint (SS) (n = 14) worn at night |
2. Age: ≥ 16 years | 2. Therapy with any kind of interocclusal appliance during the past year | ||||||
3. ≥ 12 teeth both in the upper and lower jaw | 3. TMD symptoms and signs justifiying another initial therapy than an interocclusal appliance | ||||||
4. Moderate or severe clinical signs according to Helkimo's Clinical Dysfunction Index | 4. Anterior teeth with periodontitis or fixed partial dentures | ||||||
5. Pronounced subjective symptoms according to Helkimo's Anamnestic Index | 5. Pronounced pre- or postnormal occlusion | ||||||
6. Frequent tension-type headache | 6. Deep bite | ||||||
7. Psychic disorder | |||||||
8. Language difficulties | |||||||
Study
|
Study Duration
|
Outcome parameters
|
Results
|
Authors' conclusions
| |||
Magnusson et al [9] | 6 months | - Mandibular mobility |
Within-treatment-group pre-post improvement
| 1. "The almost 100% treatment success that have been claimed after NTI treatment could not be confirmed in this study." | |||
- Deviation/deflectio |
6-month follow-up of the NTI-group (n = 10):
| 2. "The statement of a gain in chair-side time with the NTI device can be questioned. The use of NTI devices, however, eliminates one clinical visit, as well as the laboratory costs." | |||||
- n on jaw | - significant improvement (n = 6) | 3. "It can not be ruled out that long time use of NTI splints can be detrimental for the occlusion." | |||||
- opening | - some improvement (n = 1) | "All of the studied variables were in favour for the stabilization splint, compared to the NTI device." | |||||
- no change (n = 2) | |||||||
- TMJ sounds | - impairment (n = 1) | ||||||
- Pain on mandibular movement | - impaired occlusion (n = 1) | ||||||
- Muscle/TMJ pain upon palpation | - decreased use of analgetics (n = 2) | ||||||
- Number of occluding teeth | - increased use of analgetics (n = 2) | ||||||
- Time for impression-taking, interocclusal recording and adjustment of stabilization splint | - 6-point behavior scale: 3.4 → 2.1 | ||||||
- Time for fitting and adjustment of the NTI-tss device | - 11-point numerical scale: 5.9 → 3.8 | ||||||
- Adherence to the allocated splint |
6-month follow-up of the SS-group (n = 14):
| ||||||
- Use of analgetics | - significant improvement (n = 12) | ||||||
- Symptom intensity (6-point behavior scale, 11-point numerical scale) | - some improvement (n = 2) | ||||||
- decreased use of analgetics (n = 10) | |||||||
- 6-point behavior scale: 3.4 → 1.9 | |||||||
- 11-point numerical scale: 5.9 → 3.3 | |||||||
Between-groups post-treatment differences
| |||||||
- 3-month follow-up: 4 patients with NTI-tss device changed to SS due to impairment or no improvement of their symptoms, while none of the SS users changed the group. | |||||||
- For all variables, improvement was larger in the SS-group than the NTI-group | |||||||
- SS-appliances were judged to be more comfortable than the NTI-tss device | |||||||
Mean production time
| |||||||
- NTI-tss device: 27 minutes | |||||||
- SS: 17 minutes |
Study | Type of study | Aim of the study | Patient recruitment | Inclusion criteria | Exclusion criteria | n | Therapeutic comparison |
---|---|---|---|---|---|---|---|
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
| |||
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 |
Complications/side effects related to the NTI-tss-device
Study | Complications/Side effects |
---|---|
Clark & Minakuchi [2] | • Anterior open bite induced after wearing the device 24 hours a day over an extended period of time (n = 1) |
Kavaklı [21] | • Radiologically diagnosed widened periodontal ligament plus alveolar bone resorption in one tooth (n = 1/20) |
Jokstad et al [10] | • Sensitive lower front teeth (n = 1/18) |
• Dryness of the mouth while sleeping (n = 6/18) due to a forced open jaw caused by the NTI-tss design | |
• Swallowing difficulties (n = 2/18) | |
• The protruding tip of the device was felt to be annoying (n = 1/18) | |
• The device was falling out or being taken out unconsciously while sleeping (n = 2/18) | |
Magnusson et al. [9] | • Altered occlusion between the 3- and 6-month follow-up: "the vertical overbite decreased with one millimeter, and the number of occluding tooth pairs was reduced from 10 to 15" (n = 1/14) |
• Transient tenderness in the teeth when the device was used (n = 6/14) | |
• Tongue thrusting, dry mouth, increased salivation, snoring (as reported by "single patients") | |
Fleten & Gjerdet [13] | • Swallowing of an NTI-tss device, which was lodged at the esophageal entrance (n = 1) |
Fitins [27] | • Sensitive and painful maxillary central incisor (n = 1) |
• Moderate mobility of and local bone loss around three maxillary incisors |
Web link | Year | Complaints/Side effects |
---|---|---|
2003 | "This device [...] will not stop migraines, it took out pt's two front crown teeth, it causes tooth movement, joint strain [...]. This device is harmful – dangerous and it is not therapeutic. Pt had to have surgery to undo the harm that was caused by the nti splint" | |
2004 | "[...] the device was not only ineffective, but has done damage to their jaw alignment, bite, and facial appearance. The device caused them to grind their front teeth instead of their molars. Even though rptr only wore it for two weeks, rptr's jaw and their bite has not returned to "normal". During the two weeks rptr wore it, rptr suffered extreme headaches, facial pain, and their front teeth loosened. [...] Rptr's teeth are actually moving position since rptr can barely bite down without forcing their lower jaw back. Their front teeth are shifting back because they are constantly pushing against their upper teeth. Eating and chewing is challenging since they can't actually touch their upper and lower molars together without effort. Therefore, rptr's lower jaw spasms when they chew." | |
2004 | "Pt's concern is that this device poses a significant threat of death by choking. [...] A user could dislodge the nti-tss with the tongue, or, during sleep, unconsciously reach into the mouth to loosen or readjust it it is very uncomfortable-. If it remained in the mouth it could easily become lodged in the throat." | |
2006 | "Since the implant was put in, patient has been having migraine headaches and a clicking jaw. [...] Her teeth have moved so much that according to the dentist, she would need braces to move her teeth to position. Patient never had a history of migraine." | |
2006 | "Not only is his new apparatus devoid of a safety device to keep him from swallowing it in his sleep, but (1) it fit very tightly and (2) it was very difficult to remove. When he did take out the device, it felt as if he was going to pull his teeth out. Last night, when he went to sleep, he was awakened when the device broke in his mouth." |