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Non-Randomized Trial of Bruxism-Related TMD Treatments

7 maggio 2026 aggiornato da: Emre Can ÇIRALIK, Recep Tayyip Erdogan University

Comparative Evaluation of Occlusal Splint Therapy, Botulinum Toxin Type A Injection, and Combined Medical-Splint Therapy in Bruxism-Related Temporomandibular Disorder Symptoms: A Prospective Non-Randomized Open-Label Controlled Trial

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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This is a prospective, non-randomized, open-label, controlled, parallel-arm clinical trial evaluating treatment outcomes in patients with bruxism-related temporomandibular disorder symptoms. A total of 60 adult participants were assigned to one of three treatment arms: occlusal splint therapy, botulinum toxin type A injection, or combined medical-splint therapy.

Participants in the occlusal splint arm received custom-made maxillary stabilization splints and were instructed to use the splints during sleep. Participants in the botulinum toxin type A arm received a single session of intramuscular injections into the masseter and temporalis muscles. Participants in the combined medical-splint arm received a maxillary stabilization splint together with a short-term pharmacological regimen for acute symptom control.

The Fonseca Anamnestic Index was administered at baseline and at the 3-month follow-up. The primary outcome was the change in total Fonseca Anamnestic Index score from baseline to 3 months. Secondary assessments included changes in selected Fonseca Anamnestic Index sub-item scores, changes in Fonseca Anamnestic Index severity categories, and monitoring of treatment-related adverse events. Because of the nature of the interventions, participants and clinicians were not blinded to treatment assignment.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

60

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Turchia (Türkiye)
    • Rize Province
      • Rize, Rize Province, Turchia (Türkiye), 53020
        • Recep Tayyip Erdogan University Faculty of Dentistry

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Dispositivo: Occlusal 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.
Altri nomi:
  • Maxillary stabilization splint
  • Hard acrylic stabilization splint
Comparatore attivo: 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.
Droga: 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.
Sperimentale: 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.
Dispositivo: Occlusal 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.
Altri nomi:
  • Maxillary stabilization splint
  • Hard acrylic stabilization splint
Droga: Thiocolchicoside
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.
Droga: tenoxicam
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Total Fonseca Anamnestic Index Score
Lasso di tempo: Baseline to 3 months
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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Selected Fonseca Anamnestic Index Sub-Item Scores
Lasso di tempo: Baseline to 3 months
Changes in selected Fonseca Anamnestic Index sub-item scores from baseline to the 3-month follow-up. The selected items assessed mouth opening difficulty, masticatory muscle fatigue or pain during chewing, temporomandibular joint clicking, and teeth clenching or grinding habit.
Baseline to 3 months
Change in Fonseca Anamnestic Index Severity Category
Lasso di tempo: Baseline to 3 months
Change in categorical Fonseca Anamnestic Index severity classification from baseline to the 3-month follow-up. Total scores were categorized as absence of TMD-related symptoms, mild symptoms, moderate symptoms, or severe symptoms according to the Fonseca Anamnestic Index classification.
Baseline to 3 months
Treatment-Related Adverse Events
Lasso di tempo: Up to 3 months
Occurrence of treatment-related adverse events during the 3-month follow-up period, including injection-site symptoms, chewing weakness, facial asymmetry, dysphagia, medication-related intolerance, splint-related discomfort, mucosal irritation, or occlusal changes. Serious adverse events were defined as events requiring urgent medical care, hospitalization, treatment discontinuation, or resulting in persistent functional impairment.
Up to 3 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Recep Tayyip Erdogan University

Investigatori

  • Investigatore principale: Sedef KURT CIRALIK, Recep Tayyip Erdogan University, Faculty of Dentistry

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

5 agosto 2024

Completamento primario (Effettivo)

1 agosto 2025

Completamento dello studio (Effettivo)

1 agosto 2025

Date di iscrizione allo studio

Primo inviato

7 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

7 maggio 2026

Primo Inserito (Effettivo)

14 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

14 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

7 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 1081 (Förderung, Forschung und Lehre der LMU;)
  • 2024/194 (Altro identificatore: Recep Tayyip Erdoğan University Institutional Ethics Committee)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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.

Periodo di condivisione IPD

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.

Criteri di accesso alla condivisione IPD

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.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

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