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Non-Randomized Trial of Bruxism-Related TMD Treatments

NCT07586072 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-05-14

No results posted yet for this study

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

Interventions

DEVICE

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.

DRUG

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.

DRUG

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.

DRUG

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.

Sponsors & Collaborators

  • Recep Tayyip Erdogan University

    lead OTHER

Principal Investigators

  • Sedef KURT CIRALIK · Recep Tayyip Erdogan University, Faculty of Dentistry

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-05
Primary Completion
2025-08-01
Completion
2025-08-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07586072 on ClinicalTrials.gov