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

NCT07586072 | Completed Results

• 2 other identifiers: 10812024/194
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 3 months

Secondary Outcomes (3)

• Selected Fonseca Anamnestic Index Sub-Item Scores at Baseline and 3 Months

  Baseline to 3 months

• Fonseca Anamnestic Index Severity Categories at Baseline and 3 Months

  Baseline and 3 months

• Treatment-Related Adverse Events

  Up to 3 months

Study Arms (3)

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.

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.

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.

Device: Occlusal splint; Drug: Thiocolchicoside; Drug: tenoxicam

Interventions

Occlusal splint DEVICE

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

Combined Medical-Splint Therapy; Occlusal Splint Therapy

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.

Botulinum Toxin Type A Injection

Thiocolchicoside DRUG

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.

Combined Medical-Splint Therapy

tenoxicam DRUG

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.

Combined Medical-Splint Therapy

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Recep Tayyip Erdogan University: lead

Study Sites (1)

Recep Tayyip Erdogan University Faculty of Dentistry

Rize, Rize Province, 53020, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bruxism; Temporomandibular Joint Disorders

Interventions

Occlusal Splints; Botulinum Toxins, Type A; abobotulinumtoxinA; thiocolchicoside; tenoxicam

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Habits; Behavior; Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Limitations and Caveats

This study has several limitations. Treatment allocation was non-randomized and open-label; therefore, selection bias and residual confounding cannot be excluded. The sample size was limited to 20 participants per arm and follow-up was restricted to 3 months. Outcomes were mainly based on the Fonseca Anamnestic Index, without objective measures such as EMG, polysomnography, or imaging. The absence of a medical-only arm limits interpretation of the combined therapy effect.

Results Point of Contact

• Title: Sedef Kurt CIRALIK
• Organization: Recep Tayyip Erdogan University

sedef.kurt@erdogan.edu.tr

+90 537 382 78 47

Study Officials

• Sedef KURT CIRALIK

  Recep Tayyip Erdogan University, Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant, Department of Oral and Maxillofacial Surgery

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 14, 2026
• Study Start: August 5, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: July 30, 2026
• Results First Posted: July 30, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

TU (1)