An observational study in Bruxism, Temporomandibular Disorders (TMD) and Myofascial Pain, sponsored by Recep Tayyip Erdogan University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by Recep Tayyip Erdogan University · Observational
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.
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.
151 studies on the registry are indexed under Bruxism; 39 are open to participants now.
This study's enrollment of 60 is below the median of 89 across 55 observational studies indexed under Bruxism.
Browse Bruxism studies →Recep Tayyip Erdogan University is the lead sponsor of 69 studies on the registry; 13 are open to participants now.
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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.
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Exclusion Criteria:
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Occlusal splint
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.
Drug: Botulinum Toxin Type A (Dysport®)
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.
Device: Occlusal splint · Drug: Thiocolchicoside · Drug: tenoxicam
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.
Also known as: Maxillary stabilization splint, Hard acrylic stabilization splint
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.
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.
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.
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.
Time frame: Baseline to 3 months
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.
Time frame: 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).
Time frame: 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.
Time frame: Up to 3 months
A total of 60 adult patients with bruxism-related temporomandibular disorder symptoms were enrolled at the Department of Prosthodontics, Faculty of Dentistry, Recep Tayyip Erdoğan University, Rize, Türkiye. Participants were assigned to one of three treatment arms.
| Milestone | Occlusal Splint Therapy | Botulinum Toxin Type A Injection | Combined Medical-Splint Therapy |
|---|---|---|---|
| Started | 20 | 20 | 20 |
| Completed | 20 | 20 | 20 |
| Not completed | 0 | 0 | 0 |
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.
| points on a scale | Occlusal Splint Therapy | Botulinum Toxin Type A Injection | Combined Medical-Splint Therapy |
|---|---|---|---|
| Change in Total Fonseca Anamnestic Index Score | 33.75 ± 13.85 | 27.25 ± 12.62 | 39.25 ± 11.04 |
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.
| points on a scale | Occlusal Splint Therapy | Botulinum Toxin Type A Injection | Combined Medical-Splint Therapy |
|---|---|---|---|
| Q1 - Difficulty Opening the Mouth Wide, Baseline | 6.50 ± 2.86 | 5.25 ± 2.55 | 6.75 ± 2.94 |
| Q1 - Difficulty Opening the Mouth Wide, 3 Months | 2.50 ± 2.56 | 4.25 ± 2.45 | 2.50 ± 2.56 |
| Q3 - Fatigue or Muscle Pain During Chewing, Baseline | 5.75 ± 3.35 | 6.25 ± 3.19 | 7.50 ± 3.44 |
| Q3 - Fatigue or Muscle Pain During Chewing, 3 Months | 2.75 ± 3.02 | 2.75 ± 3.02 | 1.75 ± 2.45 |
| Q7 - Temporomandibular Joint Noise During Chewing or Mouth Opening, Baseline | 5.50 ± 3.20 | 5 ± 3.24 | 6 ± 3.08 |
| Q7 - Temporomandibular Joint Noise During Chewing or Mouth Opening, 3 Months | 2.50 ± 3.03 | 4.50 ± 3.59 | 2.75 ± 3.02 |
| Q8 - Clenching or Grinding Habit, Baseline | 7.50 ± 2.56 | 8.00 ± 2.51 | 7.00 ± 2.51 |
| Q8 - Clenching or Grinding Habit, 3 Months | 5.25 ± 4.72 | 3.25 ± 2.94 | 2.75 ± 3.02 |
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).
| Participants | Occlusal Splint Therapy | Botulinum Toxin Type A Injection | Combined Medical-Splint Therapy |
|---|---|---|---|
| Baseline — Absence of symptoms | 0 | 0 | 0 |
| Baseline — Mild symptoms | 4 | 4 | 1 |
| Baseline — Moderate symptoms at baseline | 8 | 10 | 6 |
| Baseline — Severe symptoms at baseline | 8 | 6 | 13 |
| 3 Months — Absence of symptoms | 2 | 2 | 4 |
| 3 Months — Mild symptoms | 16 | 13 | 12 |
| 3 Months — Moderate symptoms at baseline | 2 | 5 | 4 |
| 3 Months — Severe symptoms at baseline | 0 | 0 | 0 |
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.
| Participants | Occlusal Splint Therapy | Botulinum Toxin Type A Injection | Combined Medical-Splint Therapy |
|---|---|---|---|
| Participants with treatment-related adverse events | 0 | 0 | 0 |
| Participants without treatment-related adverse events | 20 | 20 | 20 |
Collected over Up to 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Occlusal Splint Therapy | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Botulinum Toxin Type A Injection | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Combined Medical-Splint Therapy | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
All participants assigned to the treatment arms were included in the baseline analysis population.
| Age, Continuous(Years) | Occlusal Splint Therapy | Botulinum Toxin Type A Injection | Combined Medical-Splint Therapy | Total |
|---|---|---|---|---|
| Mean | 25.10 ± 6.09 | 25.25 ± 6.72 | 29.00 ± 7.36 | 26.45 ± 6.87 |
| Sex: Female, Male(Participants) | Occlusal Splint Therapy | Botulinum Toxin Type A Injection | Combined Medical-Splint Therapy | Total |
|---|---|---|---|---|
| Female | 18 | 16 | 17 | 51 |
| Male | 2 | 4 | 3 | 9 |
| Race and Ethnicity Not Collected(Participants) | Occlusal Splint Therapy | Botulinum Toxin Type A Injection | Combined Medical-Splint Therapy | Total |
|---|---|---|---|---|
| Count of participants | — | — | — | 0 |
| Baseline Total Fonseca Anamnestic Index Score(points on a scale) | Occlusal Splint Therapy | Botulinum Toxin Type A Injection | Combined Medical-Splint Therapy | Total |
|---|---|---|---|---|
| Mean | 62.75 ± 18.39 | 59.25 ± 18.73 | 70.00 ± 16.86 | 64.00 ± 18.39 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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.
Supporting information: Study protocol
Time frame: De-identified individual participant data and available supporting information will be made available beginning 6 months after publication and will be available for 5 years.
Access criteria: De-identified individual participant data may be shared with qualified researchers for scientifically valid purposes upon reasonable request to the corresponding author. Requests will be reviewed by the study investigators, and data will be shared only after approval of the request and, where appropriate, completion of a data sharing agreement. Shared data will not include information that could directly identify participants.
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Recep Tayyip Erdogan University