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Non-Randomized Trial of Bruxism-Related TMD Treatments

7. maj 2026 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

60

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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.
Enhed: 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.
Andre navne:
  • Maxillary stabilization splint
  • Hard acrylic stabilization splint
Aktiv komparator: 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.
Medicin: 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.
Eksperimentel: 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.
Enhed: 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.
Andre navne:
  • Maxillary stabilization splint
  • Hard acrylic stabilization splint
Medicin: 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.
Medicin: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Total Fonseca Anamnestic Index Score
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Selected Fonseca Anamnestic Index Sub-Item Scores
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Recep Tayyip Erdogan University

Efterforskere

  • Ledende efterforsker: Sedef KURT CIRALIK, Recep Tayyip Erdogan University, Faculty of Dentistry

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

5. august 2024

Primær færdiggørelse (Faktiske)

1. august 2025

Studieafslutning (Faktiske)

1. august 2025

Datoer for studieregistrering

Først indsendt

7. maj 2026

Først indsendt, der opfyldte QC-kriterier

7. maj 2026

Først opslået (Faktiske)

14. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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.

IPD-delingstidsramme

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.

IPD-delingsadgangskriterier

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.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

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