TinnitusNCT07211711
Treatment of Temporomandibular Joint Disorders With a Stabilizing Occlusal Splint in Somatosensory Tinnitus
A study testing Stabilizing occlusal splint in people with Tinnitus and TMJ, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
This clinical trial aims to investigate whether treatment of temporomandibular joint disorder with a stabilizing occlusal splint is justified to alleviate somatosensory tinnitus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinnitus, TMJ, Temporomandibular Disorders (TMD)
- What is being tested?
- Stabilizing occlusal splint
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Aug 2023to 30 Jun 2026
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years old;
- Sufferers of somatosensory tinnitus and TMD for more than 6 months;
- Dentition in good health, with at least minimal occlusion up to the second premolars on both sides;
- Availability for at least 4 months of follow-up;
- Able to speak and read the Portuguese language.
Who cannot join
- Pregnant patients
- Treatment for TMD in the last 3 months;
- Treatment for tinnitus in the last 3 months;
- Use of total or partial removable prostheses
- Presence of orofacial pain disorders not related to TMD;
- Medical contraindication to treatment;
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- Reluctance to accept any designated treatment;
- Unable or unwilling to give informed consent;
- Language barrier or delay in neuropsychomotor development.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
University of São Paulo Faculty of Medicine Clinics Hospital
São Paulo, São Paulo, 05.403-905
About this study
Official title: Treatment of Temporomandibular Joint Disorders With a Stabilizing Occlusal Splint in Somatosensory Tinnitus: a Randomized Double-blind Placebo-controlled Clinical Trial
This clinical trial aims to investigate whether treatment of temporomandibular joint disorder with a stabilizing occlusal splint is justified to alleviate somatosensory tinnitus. The main questions we aim to answer are:
- Determine if treatment of temporomandibular disorder with a stabilizing occlusal splint improves somatosensory tinnitus.
- Identify which patient-related, tinnitus-related, and temporomandibular disorder-related factors contribute to the therapeutic effect.
Read the detailed description
The clinical variables of somatosensory tinnitus (ZS) will be assessed by a researcher blinded to the treatment type, using the Tinnitus Handicap Inventory (THI) and Visual Analogue Scale (VAS) at time points T1, T2, T3, T4, and T5, with 30 days interval. The THI, validated and adapted to Portuguese, is the most frequently used questionnaire in clinical trials for tinnitus patients, quantifying the subjective impact of tinnitus on quality of life across three main domains: functional, emotional, and catastrophic. THI classifies tinnitus into five grades: (a) I - negligible (0-16); (b) II - mild (18-36); (c) III - moderate (38-56); (d) IV - severe (58-76); (e) V - catastrophic (78-100). Audiometry and psychoacoustic measures of tinnitus (pitch, loudness, minimum masking level) will be performed at T1 and T5 by an audiologist blind to the treatment group.
The clinical variables of temporomandibular dysfunction (TMD) will also be assessed by a researcher blinded to the treatment type, using the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) and VAS at the same time points. The DC/TMD is a validated tool, adapted to Portuguese, used in clinical trials that provides a systematic assessment, including a standardized clinical examination and questionnaires. This classification system, based on the biopsychosocial model of pain, includes a physical assessment through Axis I, using reliable and well-operationalized diagnostic criteria, and an assessment of the psychosocial status and pain-related disability through Axis II.
Both assessments will be conducted at T1, T2, T3, T4, and T5.
- Conditions
- Tinnitus, TMJ, Temporomandibular Disorders (TMD)
- Being tested
- Stabilizing occlusal splint, placebo splint
- Keywords
- tinnitus, temporomandibular disorders, TMD, temporomandibular joint, TMJ, bite splint, occlusal splint, splint, stabilizing splint, somatosensory tinnitus
- Medical subject headings
- Tinnitus, Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stabilizing occlusal splintDevice
Maxillary stabilizing occlusal splint, made of acrylic with 2mm thickness in the posterior region. Installed and evaluated monthly for 4 months.
placebo splintDevice
Maxillary placebo non-occlusal splint, installed and evaluated monthly for 4 months.
| Study group | Role | What they receive |
|---|---|---|
| Patients with temporomandibular joint disorder and somatosensory tinnitus using occlusal splint | Active comparator | They will undergo the use of a stabilizing occlusal splint and will be followed up for 4 months. Receives: Device: Stabilizing occlusal splint |
| Patients with temporomandibular joint disorder and somatosensory tinnitus using placebo splint | Placebo comparator | They will undergo the use of a placebo splint and will be followed up for 4 months. Receives: Device: placebo splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in somatosensory tinnitus after treatment of temporomandibular joint disorder with a stabilizing occlusal splint.
Tinnitus improvement was monitored using the tinnitus handicap inventory (THI). A 25-item questionnaire measuring tinnitus-related distress. Scores range from 0 to 100. It subjectively quantifies the impact of tinnitus on the patient's quality of life and classifies tinnitus into 5 degrees: I- negligible (0-16); II- mild (18-36); III- moderate (38-56); IV- severe (58-76); V- catastrophic (78-100).
Measured: From enrollment to the end of treatment at 4 months
Secondary outcomes (1)
Somatosensory tinnitus distress reduction after treatment of temporomandibular joint dysfunction with a stabilizing occlusal splint.
Tinnitus distress was monitored by a Visual Analog Scale (VAS): Patients rated tinnitus distress on 10-point scale (0 = none; 10 = extreme)
Measured: From enrollment to the end of treatment at 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start10 Aug 2023
- Primary completion31 Dec 2025
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeanne Oiticica, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07211711
- Sponsor's protocol ID
- 67418823.4.0000.0068
- Status last verified
- Oct 2026
- First submitted
- 2 Sep 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Temporomandibular Joint Disorders With a Stabilizing Occlusal Splint in Somatosensory Tinnitus: a Randomized Double-blind Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07211711
- Acronym / sponsor ID
- 67418823.4.0000.0068
- Conditions
- Tinnitus, TMJ, Temporomandibular Disorders (TMD)
- Keywords
- tinnitus, temporomandibular disorders, TMD, temporomandibular joint, TMJ, bite splint, occlusal splint, splint
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 10 Aug 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 8 Oct 2025 (actual)
- 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.
This clinical trial aims to investigate whether treatment of temporomandibular joint disorder with a stabilizing occlusal splint is justified to alleviate somatosensory tinnitus. The main questions we aim to answer are:
- Determine if treatment of temporomandibular disorder with a stabilizing occlusal splint improves somatosensory tinnitus.
- Identify which patient-related, tinnitus-related, and temporomandibular disorder-related factors contribute to the therapeutic effect.
Detailed description
The clinical variables of somatosensory tinnitus (ZS) will be assessed by a researcher blinded to the treatment type, using the Tinnitus Handicap Inventory (THI) and Visual Analogue Scale (VAS) at time points T1, T2, T3, T4, and T5, with 30 days interval. The THI, validated and adapted to Portuguese, is the most frequently used questionnaire in clinical trials for tinnitus patients, quantifying the subjective impact of tinnitus on quality of life across three main domains: functional, emotional, and catastrophic. THI classifies tinnitus into five grades: (a) I - negligible (0-16); (b) II - mild (18-36); (c) III - moderate (38-56); (d) IV - severe (58-76); (e) V - catastrophic (78-100). Audiometry and psychoacoustic measures of tinnitus (pitch, loudness, minimum masking level) will be performed at T1 and T5 by an audiologist blind to the treatment group.
The clinical variables of temporomandibular dysfunction (TMD) will also be assessed by a researcher blinded to the treatment type, using the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) and VAS at the same time points. The DC/TMD is a validated tool, adapted to Portuguese, used in clinical trials that provides a systematic assessment, including a standardized clinical examination and questionnaires. This classification system, based on the biopsychosocial model of pain, includes a physical assessment through Axis I, using reliable and well-operationalized diagnostic criteria, and an assessment of the psychosocial status and pain-related disability through Axis II.
Both assessments will be conducted at T1, T2, T3, T4, and T5.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with temporomandibular joint disorder and somatosensory tinnitus using occlusal splint | Active comparator | Device: Stabilizing occlusal splintThey will undergo the use of a stabilizing occlusal splint and will be followed up for 4 months. |
| Patients with temporomandibular joint disorder and somatosensory tinnitus using placebo splint | Placebo comparator | Device: placebo splintThey will undergo the use of a placebo splint and will be followed up for 4 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients over 18 years old;
- Sufferers of somatosensory tinnitus and TMD for more than 6 months;
- Dentition in good health, with at least minimal occlusion up to the second premolars on both sides;
- Availability for at least 4 months of follow-up;
- Able to speak and read the Portuguese language.
Key exclusion criteria (9 listed)
- Pregnant patients
- Treatment for TMD in the last 3 months;
- Treatment for tinnitus in the last 3 months;
- Use of total or partial removable prostheses
- Presence of orofacial pain disorders not related to TMD;
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 |
|---|---|---|
| Stabilizing occlusal splintMaxillary stabilizing occlusal splint, made of acrylic with 2mm thickness in the posterior region. Installed and evaluated monthly for 4 months. | Device | Patients with temporomandibular joint disorder and somatosensory tinnitus using occlusal splint |
| placebo splintMaxillary placebo non-occlusal splint, installed and evaluated monthly for 4 months. | Device | Patients with temporomandibular joint disorder and somatosensory tinnitus using placebo splint |
Primary outcome
Changes in somatosensory tinnitus after treatment of temporomandibular joint disorder with a stabilizing occlusal splint.
Time frame: From enrollment to the end of treatment at 4 months
Tinnitus improvement was monitored using the tinnitus handicap inventory (THI). A 25-item questionnaire measuring tinnitus-related distress. Scores range from 0 to 100. It subjectively quantifies the impact of tinnitus on the patient's quality of life and classifies tinnitus into 5 degrees: I- negligible (0-16); II- mild (18-36); III- moderate (38-56); IV- severe (58-76); V- catastrophic (78-100).
1 secondary outcome
Somatosensory tinnitus distress reduction after treatment of temporomandibular joint dysfunction with a stabilizing occlusal splint.
Time frame: From enrollment to the end of treatment at 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stabilizing occlusal splint in people with Tinnitus and TMJ, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 5 inclusion and 9 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: finished, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in somatosensory tinnitus after treatment of temporomandibular joint disorder with a stabilizing occlusal splint. (time frame: From enrollment to the end of treatment at 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2026.