Botulinum Toxin-A for Bruxism Using Digital Occlusal Analysis

NCT07640035 | Not Yet Recruiting Early Phase 1

• 1 other identifier: BSEU-ONDER-002
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bruxism

Keywords

Bruxism; Digital Occlusal Analysis; Bite Force; Masseter Muscle; Occlusal Force Distribution; Botulinum Toxin Type A; Masticatory Muscle Activity; Placebo-Controlled Trial

Outcome Measures

Primary Outcomes (6)

• Change in Maximum Bite Force Measured by the OccluSense Digital Occlusal Analysis System

  Maximum bite force will be assessed using the OccluSense digital occlusal analysis system. Participants will be instructed to perform maximum intercuspation under standardized conditions. The OccluSense system will record the magnitude and distribution of occlusal forces during maximal clenching. Three consecutive measurements will be obtained at each assessment visit, and the mean value will be used for analysis. Changes in maximum bite force from baseline to 2 weeks, 3 months, and 6 months after intervention will be compared between the Botulinum Toxin-A and placebo groups to evaluate treatment-related changes in masticatory muscle function and occlusal force generation.

  Baseline, 2 Weeks, 3 Months, and 6 Months

• Change in Right/Left Occlusal Force Balance Measured by the OccluSense Digital Occlusal Analysis System

  Right/left occlusal force balance will be assessed using the OccluSense digital occlusal analysis system. The percentage distribution of occlusal forces between the right and left sides of the dental arch will be recorded during maximum intercuspation under standardized conditions. Three consecutive measurements will be obtained at each assessment visit, and the mean value will be used for analysis. Changes in right/left force balance from baseline to 2 weeks, 3 months, and 6 months after intervention will be compared between the Botulinum Toxin-A and placebo groups to evaluate treatment-related changes in occlusal force distribution and masticatory muscle function.

  Baseline, 2 Weeks, 3 Months, and 6 Months

• Change in Anterior/Posterior Occlusal Force Distribution Measured by the OccluSense Digital Occlusal Analysis System

  Anterior/posterior occlusal force distribution will be assessed using the OccluSense digital occlusal analysis system. The percentage distribution of occlusal forces between the anterior and posterior regions of the dental arch will be recorded during maximum intercuspation under standardized conditions. Three consecutive measurements will be obtained at each assessment visit, and the mean value will be used for analysis. Changes in anterior/posterior force distribution from baseline to 2 weeks, 3 months, and 6 months after intervention will be compared between the Botulinum Toxin-A and placebo groups to evaluate treatment-related changes in occlusal loading patterns and masticatory muscle function.

  Baseline, 2 Weeks, 3 Months, and 6 Months

• Change in Occlusion Time Measured by the OccluSense Digital Occlusal Analysis System

  Occlusion time will be assessed using the OccluSense digital occlusal analysis system. Occlusion time is defined as the elapsed time from the first tooth contact until maximum intercuspation is achieved during closure. Measurements will be performed under standardized conditions during maximum intercuspation. Three consecutive recordings will be obtained at each assessment visit, and the mean value will be used for analysis. Changes in occlusion time from baseline to 2 weeks, 3 months, and 6 months after intervention will be compared between the Botulinum Toxin-A and placebo groups to evaluate treatment-related changes in occlusal contact dynamics and masticatory muscle function.

  Baseline, 2 Weeks, 3 Months, and 6 Months

• Change in Disocclusion Time Measured by the OccluSense Digital Occlusal Analysis System

  Disocclusion time will be assessed using the OccluSense digital occlusal analysis system. Disocclusion time is defined as the elapsed time required for posterior teeth to separate during mandibular excursive movements following maximum intercuspation. Measurements will be performed under standardized conditions, and three consecutive recordings will be obtained at each assessment visit. The mean value of the recordings will be used for analysis. Changes in disocclusion time from baseline to 2 weeks, 3 months, and 6 months after intervention will be compared between the Botulinum Toxin-A and placebo groups to evaluate treatment-related changes in occlusal function, excursive movement dynamics, and masticatory muscle activity.

  Baseline, 2 Weeks, 3 Months, and 6 Months

• Change in Center of Force (COF) Measured by the OccluSense Digital Occlusal Analysis System

  Center of Force (COF) will be assessed using the OccluSense digital occlusal analysis system. The COF represents the overall location of the resultant occlusal force based on the distribution and magnitude of occlusal contacts across the dental arch during maximum intercuspation. Measurements will be performed under standardized conditions, and three consecutive recordings will be obtained at each assessment visit. The mean value of the recordings will be used for analysis. Changes in COF position and distribution from baseline to 2 weeks, 3 months, and 6 months after intervention will be compared between the Botulinum Toxin-A and placebo groups to evaluate treatment-related changes in occlusal force distribution, functional occlusal balance, and masticatory muscle activity.

  Baseline, 2 Weeks, 3 Months, and 6 Months

Secondary Outcomes (5)

• Change in Pain Intensity Assessed by the Visual Analog Scale (VAS)

  Baseline, 2 Weeks, 3 Months, and 6 Months

• Change in Maximum Mouth Opening Measured in Millimeters (mm)

  Baseline, 2 Weeks, 3 Months, and 6 Months

• Change in Masseter Muscle Tenderness Assessed by Clinical Examination

  Baseline, 2 Weeks, 3 Months, and 6 Months

• Change in Jaw Functional Limitation Assessed by the Jaw Functional Limitation Scale-8 (JFLS-8)

  Baseline, 2 Weeks, 3 Months, and 6 Months

• Change in Bruxism-Related Morning Symptoms and Parafunctional Habits Assessed by Self-Report Questionnaire

  Baseline, 2 Weeks, 3 Months, and 6 Months

Study Arms (2)

Botulinum Toxin-A Group

EXPERIMENTAL

Participants assigned to this arm will receive bilateral Botulinum Toxin-A injections into the masseter muscles. A total dose of 25 IU will be administered to each masseter muscle using a standardized three-point injection protocol. Participants will undergo follow-up assessments at baseline, 2 weeks, 3 months, and 6 months after treatment.

Drug: Botulinum Toxin-A injection

Placebo Group

PLACEBO COMPARATOR

Participants assigned to this arm will receive bilateral saline (0.9% sodium chloride) injections into the masseter muscles using the same anatomical injection sites and injection protocol as the experimental group. Participants will undergo follow-up assessments at baseline, 2 weeks, 3 months, and 6 months after treatment.

Drug: Placebo (saline injection)

Interventions

Botulinum Toxin-A injection DRUG

Botulinum Toxin-A administered bilaterally into the masseter muscles at a total dose of 25 IU per muscle using a standardized three-point injection protocol.

Botulinum Toxin-A Group

Placebo (saline injection) DRUG

0.9% sodium chloride solution administered bilaterally into the masseter muscles using the same anatomical sites and injection protocol as the experimental group.

Placebo Group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Bilecik Seyh Edebali Universitesi: lead

Study Sites (1)

Department of Periodontology, Bilecik Seyh Edebali University Faculty of Dentistry

Bilecik, Bilecik, 11100, Turkey (Türkiye)

Location

Related Publications (4)

• da Silva Ramalho JA, Palma LF, Ramalho KM, Tedesco TK, Morimoto S. Effect of botulinum toxin A on pain, bite force, and satisfaction of patients with bruxism: A randomized single-blind clinical trial comparing two protocols. Saudi Dent J. 2023 Jan;35(1):53-60. doi: 10.1016/j.sdentj.2022.12.008. Epub 2022 Dec 24.

  PMID: 36817026 BACKGROUND

• Li K, Tan K, Yacovelli A, Bi WG. Effect of botulinum toxin type A on muscular temporomandibular disorder: A systematic review and meta-analysis of randomized controlled trials. J Oral Rehabil. 2024 May;51(5):886-897. doi: 10.1111/joor.13648. Epub 2023 Dec 27.

  PMID: 38151884 BACKGROUND

• Manfredini D, Ahlberg J, Aarab G, Bender S, Bracci A, Cistulli PA, Conti PC, De Leeuw R, Durham J, Emodi-Perlman A, Ettlin D, Gallo LM, Haggman-Henrikson B, Hublin C, Kato T, Klasser G, Koutris M, Lavigne GJ, Paesani D, Peroz I, Svensson P, Wetselaar P, Lobbezoo F. Standardised Tool for the Assessment of Bruxism. J Oral Rehabil. 2024 Jan;51(1):29-58. doi: 10.1111/joor.13411. Epub 2023 Feb 10.

  PMID: 36597658 BACKGROUND

• Verhoeff MC, Lobbezoo F, Ahlberg J, Bender S, Bracci A, Colonna A, Dal Fabbro C, Durham J, Glaros AG, Haggman-Henrikson B, Kato T, Koutris M, Lavigne GJ, Nykanen L, Raphael KG, Svensson P, Wieckiewicz M, Manfredini D. Updating the Bruxism Definitions: Report of an International Consensus Meeting. J Oral Rehabil. 2025 Sep;52(9):1335-1342. doi: 10.1111/joor.13985. Epub 2025 May 1.

  PMID: 40312776 BACKGROUND

MeSH Terms

Conditions

Bruxism

Interventions

Botulinum Toxins, Type A; Sodium Chloride

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Habits; Behavior

Intervention Hierarchy (Ancestors)

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; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Yasemin Beliz Önder, DDS, PhD

CONTACT

+905532502064; ybyilmaz@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors responsible for clinical examinations and digital occlusal analysis measurements will be blinded to treatment allocation. The clinician administering the injections will not be blinded due to the nature of the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants with bruxism will be randomly assigned to one of two parallel groups: a Botulinum Toxin-A (BTX-A) treatment group or a placebo group. Participants in the BTX-A group will receive bilateral masseter muscle injections of Botulinum Toxin-A, while participants in the placebo group will receive saline injections using the same injection protocol. Outcomes will be assessed longitudinally at baseline, 2 weeks, 3 months, and 6 months after the intervention.

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 10, 2026
• Study Start (Estimated): July 20, 2026
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): July 20, 2027
• Last Updated: June 10, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)