Short-Term Symptom Changes in Adults With Teeth Clenching or Grinding and Jaw Symptoms Receiving Splint, Botulinum Toxin, or Medication Plus Splint Care

Recep Tayyip Erdogan University

Status and phase: Completed; Phase 4

Conditions: Bruxism; Temporomandibular Disorders (TMD); Myofascial Pain

Treatments: Drug: Thiocolchicoside; Device: Occlusal splint; Drug: tenoxicam; Drug: Botulinum Toxin Type A (Dysport®)

Study type: Observational

Funder types: Other

Identifiers

NCT07586072

1081

2024/194 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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 design

60 participants in 3 patient groups

Occlusal Splint Therapy

Description:

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.

Treatment:

Device: Occlusal splint

Botulinum Toxin Type A Injection

Description:

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.

Treatment:

Drug: Botulinum Toxin Type A (Dysport®)

Combined Medical-Splint Therapy

Description:

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.

Treatment:

Drug: tenoxicam

Device: Occlusal splint

Drug: Thiocolchicoside