BruxismNCT07586072
Short-Term Symptom Changes in Adults With Teeth Clenching or Grinding and Jaw Symptoms Receiving Splint, Botulinum Toxin, or Medication Plus Splint Care
An observational study of Bruxism and Temporomandibular Disorders (TMD), run by Recep Tayyip Erdogan University at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study evaluated short-term patient-reported symptom changes in adults with bruxism-related and temporomandibular disorder symptoms who received one of three clinically selected management approaches: occlusal splint therapy, botulinum toxin type A injection, or short-term pharmacotherapy… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bruxism, Temporomandibular Disorders (TMD), Myofascial Pain
- What is being tested?
- Occlusal splint, Botulinum Toxin Type A (Dysport®) and Thiocolchicoside
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Aug 2024to 1 Aug 2025
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: The study population consisted of adults presenting to the Department of Prosthodontics, Faculty of Dentistry, Recep Tayyip Erdoğan University, with reported clenching or grinding and temporomandibular disorder related symptoms. Eligible participants who met the predefined inclusion and exclusion criteria were included during the study period and were managed according to routine clinical indication, symptom profile, shared decision making, and patient preference.
Who may be able to join
- Adults aged 18 years or older.
- Presence of bruxism-related temporomandibular disorder symptoms.
- Self-reported sleep or awake bruxism based on clenching or grinding awareness.
- Clinical signs compatible with bruxism, including dental attrition, cupped-out wear facets, or shiny occlusal surfaces.
- Absence of known systemic conditions that could interfere with treatment or outcome assessment.
- Ability to provide written informed consent.
Who cannot join
- Age younger than 18 years.
- Presence of systemic or neurological disorders.
- Uncontrolled psychiatric conditions.
- Infection or inflammatory lesions at the planned injection sites.
- History of maxillofacial surgery or severe trauma in the relevant orofacial region.
- Inability or unwillingness to provide written informed consent.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Recep Tayyip Erdogan University Faculty of Dentistry
Rize, Rize Province, 53020
About this study
Official title: Short-Term Patient-Reported Symptom Changes Across Clinically Selected Management Pathways in Adults With Bruxism-Related and Temporomandibular Disorder Symptoms: A Prospective Non-Randomized Observational Study
This prospective observational study evaluated short-term patient-reported symptom changes in adults with bruxism-related and temporomandibular disorder symptoms who received one of three clinically selected management approaches: occlusal splint therapy, botulinum toxin type A injection, or short-term pharmacotherapy combined with splint therapy. Management selection reflected routine clinical decision-making based on clinical indication, symptom profile, shared decision-making, and patient preference and was not determined by random allocation. Symptom severity was assessed at baseline and after 3 months using the Fonseca Anamnestic Index. The primary objective was to describe the 3-month change in total Fonseca Anamnestic Index scores within the clinically selected cohorts and to explore whether longitudinal change patterns differed among them. Selected Fonseca Anamnestic Index items, severity-category changes, and clinically recorded treatment-related adverse events were also evaluated as secondary outcomes.
Read the detailed description
This was a 3-month prospective, non-randomized observational cohort study of adults with bruxism-related and temporomandibular disorder symptoms managed according to routine clinical practice. A total of 60 participants were included in three clinically selected management cohorts: occlusal splint therapy, botulinum toxin type A injection, and short-term pharmacotherapy combined with splint therapy.
Management selection was based on routine clinical decision-making according to clinical indication, predominant symptom profile, shared decision-making, and patient preference rather than random allocation. The study protocol was designed to observe indication-based clinical management and did not require participants to be allocated randomly to interchangeable treatment options. Because the clinical characteristics influencing management selection could also influence subsequent symptom changes, the cohorts were not assumed to be clinically equivalent or exchangeable at baseline. Between-cohort analyses were therefore considered exploratory rather than estimates of comparative treatment effectiveness.
Participants in the occlusal splint cohort received custom-made maxillary stabilization splints and were instructed to wear the splints during sleep. Participants in the botulinum toxin type A cohort received a single session of bilateral intramuscular Dysport® injections into the masseter and temporalis muscles. Participants in the short-term pharmacotherapy plus splint cohort received the same maxillary stabilization splint protocol together with short-term oral thiocolchicoside and tenoxicam for symptom control.
The Turkish version of the Fonseca Anamnestic Index was administered at baseline and at the 3-month follow-up as a patient-reported measure of temporomandibular disorder-related symptom severity. The primary outcome was the change in total Fonseca Anamnestic Index score from baseline to 3 months. The study primarily aimed to describe within-cohort changes and to explore whether longitudinal change patterns differed among the three clinically selected cohorts. Secondary exploratory assessments included changes in selected Fonseca Anamnestic Index sub-item scores, shifts in Fonseca Anamnestic Index severity categories, and clinically recorded treatment-related adverse events during follow-up.
Because the management approaches were clinically distinct, participants and treating clinicians were not blinded. The study was not designed to establish causal comparative effectiveness or superiority among the three management approaches.
- Conditions
- Bruxism, Temporomandibular Disorders (TMD), Myofascial Pain
- Being tested
- Occlusal splint, Botulinum Toxin Type A (Dysport®), Thiocolchicoside, tenoxicam
- Keywords
- Occlusal splint, Botulinum toxin type A, Medical-splint therapy, Fonseca Anamnestic Index, Masticatory muscle pain, Bruxism-related TMD symptoms, Temporomandibular disorder symptoms
- Medical subject headings
- Bruxism, Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occlusal splintDevice
Also called Maxillary stabilization splint, Hard acrylic stabilization splint
Custom-made maxillary stabilization splints were fabricated from hard acrylic resin and adjusted to obtain simultaneous bilateral posterior contacts in centric relation and canine guidance during eccentric movements. Participants were instructed to wear the splints during sleep for at least eight hours per night.
Botulinum Toxin Type A (Dysport®)Drug
Botulinum toxin type A was administered as a single intramuscular injection session. Dysport was reconstituted with 2 mL sterile 0.9% saline. A total dose of 160 U Dysport was administered per participant, consisting of 60 U into each masseter muscle and 20 U into each temporalis muscle.
ThiocolchicosideDrug
Thiocolchicoside 8 mg/day was prescribed as part of a short-term pharmacological regimen for acute symptom control in the combined medical-splint therapy arm. The medication was used for 7 to 10 days.
tenoxicamDrug
Tenoxicam 20 mg/day was prescribed as part of a short-term pharmacological regimen for acute symptom control in the combined medical-splint therapy arm. The medication was used for 7 to 10 days.
| Study group | Role | What they receive |
|---|---|---|
| Occlusal Splint Therapy | Participants in this arm received custom-made maxillary stabilization splints. The splints were adjusted to obtain simultaneous bilateral posterior contacts in centric relation and canine guidance during eccentric movements. Participants were instructed to wear the splints during sleep for at least eight hours per night for 3 months. Receives: Device: Occlusal splint | |
| Botulinum Toxin Type A Injection | Participants in this arm received a single session of intramuscular botulinum toxin type A injections. Dysport was reconstituted with 2 mL sterile 0.9% saline. A total dose of 160 U Dysport was administered per participant, consisting of 60 U into each masseter muscle and 20 U into each temporalis muscle. Receives: Drug: Botulinum Toxin Type A (Dysport®) | |
| Combined Medical-Splint Therapy | Participants in this arm received a custom-made maxillary stabilization splint using the same design and adjustment protocol as the splint arm. In addition, a short-term pharmacological regimen consisting of thiocolchicoside 8 mg/day and tenoxicam 20 mg/day was prescribed for 7 to 10 days for acute symptom control. Participants continued nocturnal splint use during the follow-up period. Receives: Device: Occlusal splint; Drug: Thiocolchicoside; Drug: tenoxicam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Fonseca Anamnestic Index Score
Change in total Fonseca Anamnestic Index score from baseline to the 3-month follow-up. The Fonseca Anamnestic Index is a 10-item symptom-based questionnaire used to assess temporomandibular disorder-related symptom severity. Total scores range from 0 to 100, with higher scores indicating more severe symptoms. The change score was calculated as pre-treatment total score minus post-treatment total score; therefore, higher positive change values indicate greater symptom improvement.
Measured: Baseline to 3 months
Secondary outcomes (3)
Selected Fonseca Anamnestic Index Sub-Item Scores at Baseline and 3 Months
Selected Fonseca Anamnestic Index sub-item scores were assessed at baseline and at the 3-month follow-up. Each selected item is scored from 0 to 10, with higher scores indicating more severe symptoms. The selected items assessed mouth opening difficulty, masticatory muscle fatigue or pain during chewing, temporomandibular joint clicking, and teeth clenching or grinding habit.
Measured: Baseline to 3 months
Fonseca Anamnestic Index Severity Categories at Baseline and 3 Months
Fonseca Anamnestic Index severity categories were assessed at baseline and at the 3-month follow-up. Total Fonseca Anamnestic Index scores range from 0 to 100, with higher scores indicating more severe temporomandibular disorder-related symptoms. Severity categories were defined as absence of symptoms (0-15), mild symptoms (20-40), moderate symptoms (45-65), and severe symptoms (70-100).
Measured: Baseline and 3 months
Treatment-Related Adverse Events
Treatment-related adverse events were monitored during the 3-month follow-up period. Participants were questioned about injection-related, medication-related, and splint-related adverse effects. Serious adverse events were defined as events requiring urgent medical care, hospitalization, treatment discontinuation, or resulting in persistent functional impairment.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start5 Aug 2024
- Primary completion1 Aug 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BruxismStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emre Can ÇIRALIK, Recep Tayyip Erdogan University
- Investigators
- Sedef KURT CIRALIK, Principal investigator, Recep Tayyip Erdogan University, Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07586072
- Sponsor's protocol ID
- 1081
- Other IDs
- 2024/194
- Status last verified
- May 2026
- First submitted
- 7 May 2026
- Last updated
- 30 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in this study may be made available from the corresponding author upon reasonable request. Data will be shared only after review of the scientific purpose of the request and, where appropriate, completion of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-Term Patient-Reported Symptom Changes Across Clinically Selected Management Pathways in Adults With Bruxism-Related and Temporomandibular Disorder Symptoms: A Prospective Non-Randomized Observational Study
- ClinicalTrials.gov ID
- NCT07586072
- Acronym / sponsor ID
- 1081
- Conditions
- Bruxism, Temporomandibular Disorders (TMD), Myofascial Pain
- Keywords
- Occlusal splint, Botulinum toxin type A, Medical-splint therapy, Fonseca Anamnestic Index, Masticatory muscle pain, Bruxism-related TMD symptoms, Temporomandibular disorder symptoms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan UniversityUniversity, hospital or other
- Study start
- 5 Aug 2024 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 14 May 2026 (actual)
- Results
- Posted 30 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective observational study evaluated short-term patient-reported symptom changes in adults with bruxism-related and temporomandibular disorder symptoms who received one of three clinically selected management approaches: occlusal splint therapy, botulinum toxin type A injection, or short-term pharmacotherapy combined with splint therapy. Management selection reflected routine clinical decision-making based on clinical indication, symptom profile, shared decision-making, and patient preference and was not determined by random allocation. Symptom severity was assessed at baseline and after 3 months using the Fonseca Anamnestic Index. The primary objective was to describe the 3-month change in total Fonseca Anamnestic Index scores within the clinically selected cohorts and to explore whether longitudinal change patterns differed among them. Selected Fonseca Anamnestic Index items, severity-category changes, and clinically recorded treatment-related adverse events were also evaluated as secondary outcomes.
Detailed description
This was a 3-month prospective, non-randomized observational cohort study of adults with bruxism-related and temporomandibular disorder symptoms managed according to routine clinical practice. A total of 60 participants were included in three clinically selected management cohorts: occlusal splint therapy, botulinum toxin type A injection, and short-term pharmacotherapy combined with splint therapy.
Management selection was based on routine clinical decision-making according to clinical indication, predominant symptom profile, shared decision-making, and patient preference rather than random allocation. The study protocol was designed to observe indication-based clinical management and did not require participants to be allocated randomly to interchangeable treatment options. Because the clinical characteristics influencing management selection could also influence subsequent symptom changes, the cohorts were not assumed to be clinically equivalent or exchangeable at baseline. Between-cohort analyses were therefore considered exploratory rather than estimates of comparative treatment effectiveness.
Participants in the occlusal splint cohort received custom-made maxillary stabilization splints and were instructed to wear the splints during sleep. Participants in the botulinum toxin type A cohort received a single session of bilateral intramuscular Dysport® injections into the masseter and temporalis muscles. Participants in the short-term pharmacotherapy plus splint cohort received the same maxillary stabilization splint protocol together with short-term oral thiocolchicoside and tenoxicam for symptom control.
The Turkish version of the Fonseca Anamnestic Index was administered at baseline and at the 3-month follow-up as a patient-reported measure of temporomandibular disorder-related symptom severity. The primary outcome was the change in total Fonseca Anamnestic Index score from baseline to 3 months. The study primarily aimed to describe within-cohort changes and to explore whether longitudinal change patterns differed among the three clinically selected cohorts. Secondary exploratory assessments included changes in selected Fonseca Anamnestic Index sub-item scores, shifts in Fonseca Anamnestic Index severity categories, and clinically recorded treatment-related adverse events during follow-up.
Because the management approaches were clinically distinct, participants and treating clinicians were not blinded. The study was not designed to establish causal comparative effectiveness or superiority among the three management approaches.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Occlusal Splint Therapy | – | Device: Occlusal splintParticipants in this arm received custom-made maxillary stabilization splints. The splints were adjusted to obtain simultaneous bilateral posterior contacts in centric relation and canine guidance during eccentric movements. Participants were instructed to wear the splints during sleep for at least eight hours per night for 3 months. |
| Botulinum Toxin Type A Injection | – | Drug: Botulinum Toxin Type A (Dysport®)Participants in this arm received a single session of intramuscular botulinum toxin type A injections. Dysport was reconstituted with 2 mL sterile 0.9% saline. A total dose of 160 U Dysport was administered per participant, consisting of 60 U into each masseter muscle and 20 U into each temporalis muscle. |
| Combined Medical-Splint Therapy | – | Device: Occlusal splint, Drug: Thiocolchicoside, Drug: tenoxicamParticipants in this arm received a custom-made maxillary stabilization splint using the same design and adjustment protocol as the splint arm. In addition, a short-term pharmacological regimen consisting of thiocolchicoside 8 mg/day and tenoxicam 20 mg/day was prescribed for 7 to 10 days for acute symptom control. Participants continued nocturnal splint use during the follow-up period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of adults presenting to the Department of Prosthodontics, Faculty of Dentistry, Recep Tayyip Erdoğan University, with reported clenching or grinding and temporomandibular disorder related symptoms. Eligible participants who met the predefined inclusion and exclusion criteria were included during the study period and were managed according to routine clinical indication, symptom profile, shared decision making, and patient preference.
Key inclusion criteria (6 listed)
- Adults aged 18 years or older.
- Presence of bruxism-related temporomandibular disorder symptoms.
- Self-reported sleep or awake bruxism based on clenching or grinding awareness.
- Clinical signs compatible with bruxism, including dental attrition, cupped-out wear facets, or shiny occlusal surfaces.
- Absence of known systemic conditions that could interfere with treatment or outcome assessment.
Key exclusion criteria (6 listed)
- Age younger than 18 years.
- Presence of systemic or neurological disorders.
- Uncontrolled psychiatric conditions.
- Infection or inflammatory lesions at the planned injection sites.
- History of maxillofacial surgery or severe trauma in the relevant orofacial region.
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 |
|---|---|---|
| Occlusal splintAlso: Maxillary stabilization splint, Hard acrylic stabilization splintCustom-made maxillary stabilization splints were fabricated from hard acrylic resin and adjusted to obtain simultaneous bilateral posterior contacts in centric relation and canine guidance during eccentric movements. Participants were instructed to wear the splints during sleep for at least eight hours per night. | Device | Combined Medical-Splint Therapy, Occlusal Splint Therapy |
| Botulinum Toxin Type A (Dysport®)Botulinum toxin type A was administered as a single intramuscular injection session. Dysport was reconstituted with 2 mL sterile 0.9% saline. A total dose of 160 U Dysport was administered per participant, consisting of 60 U into each masseter muscle and 20 U into each temporalis muscle. | Drug | Botulinum Toxin Type A Injection |
| ThiocolchicosideThiocolchicoside 8 mg/day was prescribed as part of a short-term pharmacological regimen for acute symptom control in the combined medical-splint therapy arm. The medication was used for 7 to 10 days. | Drug | Combined Medical-Splint Therapy |
| tenoxicamTenoxicam 20 mg/day was prescribed as part of a short-term pharmacological regimen for acute symptom control in the combined medical-splint therapy arm. The medication was used for 7 to 10 days. | Drug | Combined Medical-Splint Therapy |
Primary outcome
Change in Total Fonseca Anamnestic Index Score
Time frame: Baseline to 3 months
Change in total Fonseca Anamnestic Index score from baseline to the 3-month follow-up. The Fonseca Anamnestic Index is a 10-item symptom-based questionnaire used to assess temporomandibular disorder-related symptom severity. Total scores range from 0 to 100, with higher scores indicating more severe symptoms. The change score was calculated as pre-treatment total score minus post-treatment total score; therefore, higher positive change values indicate greater symptom improvement.
3 secondary outcomes
Selected Fonseca Anamnestic Index Sub-Item Scores at Baseline and 3 Months
Time frame: Baseline to 3 months
Fonseca Anamnestic Index Severity Categories at Baseline and 3 Months
Time frame: Baseline and 3 months
Treatment-Related Adverse Events
Time frame: Up to 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in this study may be made available from the corresponding author upon reasonable request. Data will be shared only after review of the scientific purpose of the request and, where appropriate, completion of a data sharing agreement.
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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.
Sedef KURT CIRALIK principal investigator
Recep Tayyip Erdogan University, Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bruxism and Temporomandibular Disorders (TMD), run by Recep Tayyip Erdogan University at 1 site in Turkey (Türkiye).
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 6 inclusion and 6 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 30 Jul 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 Turkey (Türkiye). 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. 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?
Yes. Results are posted in the registry (first posted 30 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Total Fonseca Anamnestic Index Score (time frame: Baseline to 3 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 30 Jul 2026.