Temporomandibular Joint DisordersPhase 2/3PTCRSTIMNCT02908568
Stimulation of the Proprioceptive Trigeminocardiac Reflex
A Phase 2/3 study testing Spring device and Mandible stimulator in people with Temporomandibular Joint Disorders, run by Azienda USL 12 Versilia.
Trial summary
Study over muscular stretching to reduce pain the oral cavity. Read more about this study
- Who is it for?
- Ages 8 years and olderHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Joint Disorders
- What is being tested?
- Spring device and Mandible stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Aug 2017
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All the subjets up to seventy years
Who cannot join
- Subjects under eight years
About this study
Official title: Effect of Stimulation of the Proprioceptive Trigeminocardiac Reflex Through Medical Device for the Pain of Patients With Temporomandibular Disorders
Study over muscular stretching to reduce pain the oral cavity.
Read the detailed description
It is a current opinion that muscular stretching is able to reduce pain and to allow increase of the opening excursion at the joints. To investigate this possibility in the face, the investigators developed a method of stretching associated with large dynamic jaws during chewing using a special device (Spring Device ®) for ten minutes, allowing the muscles of the oral cavity to relax. The height of the bite was set as two-thirds of the maximum opening (max. 2 cm.) of the mouth at rest (without forcing) thus avoiding maintaining the head of the condyle at maximum aperture for a long time. The subjects were then analyzed by means of kinesiography to determine the changes in the vertical dimension. Increasing stretching produces neuromuscular relaxation and a reduction of pain. This study showed that this therapy induces oral and extraoral pain reduction and increases neck mobility and mouth opening. The stimulation of trigeminal receptors is an important drive for therapy in the trigeminocardiac reflex (TCR).
- Conditions
- Temporomandibular Joint Disorders
- Being tested
- Spring device, Mandible stimulator
- Keywords
- mandibular stretching, trigeminocardiac reflex
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spring deviceDevice
Brisk dilatation of fhe mouth.
Mandible stimulatorDevice
Stimulation of fhe mouth.
| Study group | Role | What they receive |
|---|---|---|
| Spring device | Experimental | Brisk dilatation of fhe mouth. Receives: Device: Spring device |
| Mandible stimulator | Sham comparator | Stimulation of fhe mouth. Receives: Device: Mandible stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mandibular stretching influences the temporomandibular disorders
It is a current opinion that muscular stretching is able to reduce pain and to allow increase of the opening excursion at the joints.
To investigate this possibility in the face, the investigators developed a method of stretching associated with large dynamic jaws during chewing using a special device (Spring Device ®) for ten minutes, allowing the muscles of the oral cavity to relax.
Measured: up to 24 weeks
Secondary outcomes (1)
mandibular stretching induces a reduction of facial contraction and decrease of heart rate
Those effects are described as trigemino-cardiac reflex. Application of a spring device (which consists of thin sheet of surgical steel bent in to a loop) induces a decrease of blood pressure and heart rate.
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionAug 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular Joint DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda USL 12 Versilia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PROF. UGO COVANI, Azienda USL 12 Versilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02908568
- Sponsor's protocol ID
- ISTITUTO STOMATOLOGICO TOSCANO
- Acronym
- PTCRSTIM
- Status last verified
- Sep 2016
- First submitted
- 7 Sep 2016
- Last updated
- 22 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Tonlorenzi D, Brunelli M, Conti M, Covani U, Traina G. An observational study of the effects of using an high oral splint on pain control. Arch Ital Biol. 2019 Sep 30;157(2-3):66-75. doi: 10.12871/00039829201923.
PubMed 31821530
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Stimulation of the Proprioceptive Trigeminocardiac Reflex Through Medical Device for the Pain of Patients With Temporomandibular Disorders
- ClinicalTrials.gov ID
- NCT02908568
- Acronym / sponsor ID
- PTCRSTIM / ISTITUTO STOMATOLOGICO TOSCANO
- Conditions
- Temporomandibular Joint Disorders
- Keywords
- mandibular stretching, trigeminocardiac reflex
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Azienda USL 12 VersiliaUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 21 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study over muscular stretching to reduce pain the oral cavity.
Detailed description
It is a current opinion that muscular stretching is able to reduce pain and to allow increase of the opening excursion at the joints. To investigate this possibility in the face, the investigators developed a method of stretching associated with large dynamic jaws during chewing using a special device (Spring Device ®) for ten minutes, allowing the muscles of the oral cavity to relax. The height of the bite was set as two-thirds of the maximum opening (max. 2 cm.) of the mouth at rest (without forcing) thus avoiding maintaining the head of the condyle at maximum aperture for a long time. The subjects were then analyzed by means of kinesiography to determine the changes in the vertical dimension. Increasing stretching produces neuromuscular relaxation and a reduction of pain. This study showed that this therapy induces oral and extraoral pain reduction and increases neck mobility and mouth opening. The stimulation of trigeminal receptors is an important drive for therapy in the trigeminocardiac reflex (TCR).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spring device | Experimental | Device: Spring deviceBrisk dilatation of fhe mouth. |
| Mandible stimulator | Sham comparator | Device: Mandible stimulatorStimulation of fhe mouth. |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All the subjets up to seventy years
Key exclusion criteria (1 listed)
- Subjects under eight years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spring deviceBrisk dilatation of fhe mouth. | Device | Spring device |
| Mandible stimulatorStimulation of fhe mouth. | Device | Mandible stimulator |
Primary outcome
Mandibular stretching influences the temporomandibular disorders
Time frame: up to 24 weeks
It is a current opinion that muscular stretching is able to reduce pain and to allow increase of the opening excursion at the joints. To investigate this possibility in the face, the investigators developed a method of stretching associated with large dynamic jaws during chewing using a special device (Spring Device ®) for ten minutes, allowing the muscles of the oral cavity to relax.
1 secondary outcome
mandibular stretching induces a reduction of facial contraction and decrease of heart rate
Time frame: up to 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2016.
- Derived from this study: PubMed 31821530Tonlorenzi D, Brunelli M, Conti M, Covani U, Traina G. An observational study of the effects of using an high oral splint on pain control. Arch Ital Biol. 2019 Sep 30;157(2-3):66-75. doi: 10.12871/00039829201923.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Spring device and Mandible stimulator in people with Temporomandibular Joint Disorders, run by Azienda USL 12 Versilia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mandibular stretching influences the temporomandibular disorders (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02908568, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2016.