Botulinum Toxin-A for Bruxism Using Digital Occlusal Analysis

Starting soon · Early Phase 1 · Has a placebo group

Conditions studied: Bruxism

In brief

Bruxism is a repetitive jaw-muscle activity that may lead to tooth wear, muscle pain, headaches, and functional limitations. Current diagnostic approaches mainly rely on self-reported symptoms and clinical examination findings, which may not accurately reflect ongoing muscle activity. Digital occlusal analysis systems offer an objective method for evaluating bite force and occlusal function. The aim of this randomized, placebo-controlled clinical trial is to investigate whether a digital occlusal analysis system can objectively assess bruxism and monitor treatment response following Botulinum Toxin-A (BTX-A) injections. Thirty-six adults diagnosed with bruxism will be randomly assigned to receive either BTX-A injections or placebo injections into the masseter muscles. Clinical examinations, patient-reported outcomes, and digital occlusal measurements will be collected at baseline and at 2 weeks, 3 months, and 6 months after treatment. Primary outcomes include bite force characteristics, force distribution, occlusion time, disocclusion time, and center of force. Secondary outcomes include pain intensity, maximum mouth opening, muscle tenderness, functional limitation scores, and self-reported bruxism-related symptoms. This study aims to provide objective evidence regarding the usefulness of digital occlusal analysis in the diagnosis and follow-up of bruxism and to evaluate the effectiveness of Botulinum Toxin-A treatment using both objective and subjective outcome measures.

Key facts

Study ID

NCT07640035

Run by

Bilecik Seyh Edebali Universitesi

People needed

36

Starts

2026-07-20

Expected to finish

2027-07-20

Last updated by the study team

2026-06-10

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults aged 18 years and older
• Diagnosis of bruxism based on self-report and clinical assessment
• Systemically healthy individuals
• Angle Class I occlusion
• Ability and willingness to provide written informed consent and comply with study procedures

You may not qualify if…

• Presence of temporomandibular joint pathology
• Neuromuscular disorders
• Pregnancy or lactation
• Known allergy or hypersensitivity to Botulinum Toxin-A
• Use of medications that may affect muscle function
• Missing posterior teeth
• Ongoing orthodontic treatment
• Angle Class II or Class III malocclusion
• Previous Botulinum Toxin injection into the masseter muscles

Where it is running

• Department of Periodontology, Bilecik Seyh Edebali University Faculty of Dentistry — Bilecik, Bilecik, Turkey (Türkiye)

Full record on ClinicalTrials.gov

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