Non-Randomized Trial of Bruxism-Related TMD Treatments

NCT07586072 | Completed Phase 4

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

Brief Summary

This study compares three treatment approaches for adults with bruxism-related temporomandibular disorder symptoms: occlusal splint therapy, botulinum toxin type A injection, and combined medical-splint therapy. Participants were assigned to one of three non-randomized treatment arms according to clinical indication, symptom profile, shared decision-making, and patient preference. Symptom severity was assessed before treatment and after 3 months using the Fonseca Anamnestic Index. The primary purpose of the study was to compare the 3-month change in total Fonseca Anamnestic Index scores among the treatment arms. Selected symptom items and treatment-related adverse events were also evaluated during follow-up.

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 change score was calculated as pre-treatment total score minus post-treatment total score. Higher positive values indicate greater symptom improvement.

  Baseline to 3 months

Secondary Outcomes (3)

• Change in Selected Fonseca Anamnestic Index Sub-Item Scores

  Baseline to 3 months

• Change in Fonseca Anamnestic Index Severity Category

  Baseline to 3 months

• Treatment-Related Adverse Events

  Up to 3 months

Study Arms (3)

Occlusal Splint Therapy

ACTIVE COMPARATOR

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

ACTIVE COMPARATOR

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

EXPERIMENTAL

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+)

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

Study Officials

• Sedef KURT CIRALIK

  Recep Tayyip Erdogan University, Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: No masking was performed because of the nature of the interventions. Participants and care providers were aware of the assigned treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant, Department of Oral and Maxillofacial Surgery

Model Details: Participants were assigned to one of three parallel active treatment arms: occlusal splint therapy, botulinum toxin type A injection, or combined medical-splint therapy. Treatment assignment was non-randomized and open-label.

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: May 14, 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)