BruxismEarly Phase 1NCT07640035
Botulinum Toxin-A for Bruxism Using Digital Occlusal Analysis
A Early Phase 1 study testing Botulinum Toxin-A injection in people with Bruxism, run by Bilecik Seyh Edebali Universitesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Bruxism
- What is being tested?
- Botulinum Toxin-A injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Oct 2026to 20 Jul 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Ongoing orthodontic treatment
- Angle Class II or Class III malocclusion
- Previous Botulinum Toxin injection into the masseter muscles
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Department of Periodontology, Bilecik Seyh Edebali University Faculty of Dentistry
Bilecik, Bilecik, 11100
Beliz Yasemin Önder, 05532502064, ybyilmaz@gmail.com
Muhammed Emin Kalender, DDS, +90 546 610 78 27, ybyilmaz@gmail.com
About this study
Official title: Objective Assessment of Bruxism and Treatment Response Using Digital Occlusal Analysis: A Clinical Study of Botulinum Toxin-A
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.
Read more
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.
Read the detailed description
Bruxism is a repetitive jaw-muscle activity characterized by clenching and/or grinding of the teeth and is associated with various oral and craniofacial consequences, including tooth wear, muscle pain, headaches, and temporomandibular disorders. Recent international consensus statements define bruxism as a motor behavior rather than a disease entity, emphasizing the need for multidimensional assessment approaches.
Current diagnostic methods primarily rely on self-reported symptoms and clinical findings. However, self-reports may be affected by recall bias and limited awareness, while clinical signs often reflect cumulative tissue changes rather than ongoing functional activity. Although electromyography and polysomnography can provide objective information regarding masticatory muscle activity, their routine clinical use is limited by cost, technical complexity, and accessibility.
Digital occlusal analysis systems have emerged as promising tools for the objective evaluation of occlusal force characteristics. These technologies allow quantitative assessment of bite force distribution, occlusal timing, and force balance, potentially providing indirect information about masticatory muscle function. Despite their increasing clinical use, the role of digital occlusal analysis systems in the diagnosis and longitudinal monitoring of bruxism remains insufficiently investigated.
Botulinum Toxin-A (BTX-A) has been increasingly used for the management of bruxism because of its ability to reduce masticatory muscle activity through inhibition of acetylcholine release at the neuromuscular junction. Previous studies have demonstrated reductions in bite force and symptom severity following BTX-A treatment. However, most available studies have focused on subjective outcomes or lacked placebo-controlled designs and objective functional measurements.
This study was designed to address these gaps by investigating whether digital occlusal analysis can serve as an objective tool for evaluating bruxism and monitoring therapeutic response. The findings may contribute to the development of more objective diagnostic and follow-up strategies for bruxism while providing additional evidence regarding the functional effects of Botulinum Toxin-A treatment.
- Conditions
- Bruxism
- Being tested
- Botulinum Toxin-A injection, Placebo (saline injection)
- Keywords
- Bruxism, Digital Occlusal Analysis, Bite Force, Masseter Muscle, Occlusal Force Distribution, Botulinum Toxin Type A, Masticatory Muscle Activity, Placebo-Controlled Trial
- Medical subject headings
- Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin-A injectionDrug
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo (saline injection) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 2 Weeks, 3 Months, and 6 Months
Secondary outcomes (5)
Change in Pain Intensity Assessed by the Visual Analog Scale (VAS)
Pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst pain imaginable. Participants will be asked to rate the intensity of pain or discomfort associated with bruxism-related symptoms, including masticatory muscle pain and jaw discomfort. Changes in VAS pain scores 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 the effect of treatment on pain-related outcomes.
Measured: Baseline, 2 Weeks, 3 Months, and 6 Months
Change in Maximum Mouth Opening Measured in Millimeters (mm)
Maximum mouth opening will be assessed as the maximum interincisal distance measured in millimeters (mm) between the incisal edges of the maxillary and mandibular central incisors during unassisted maximum mouth opening. Measurements will be obtained using a millimeter ruler under standardized clinical conditions at each assessment visit. Standardized clinical photographs will also be taken to document the measurements. Changes in maximum mouth opening 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 mandibular function and jaw mobility.
Measured: Baseline, 2 Weeks, 3 Months, and 6 Months
Change in Masseter Muscle Tenderness Assessed by Clinical Examination
Masseter muscle tenderness will be assessed by standardized clinical examination using digital palpation of the bilateral masseter muscles. Participants will be asked to rate tenderness or discomfort elicited during palpation, and findings will be recorded at each assessment visit. Changes in masseter muscle tenderness 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 pain and sensitivity associated with bruxism.
Measured: Baseline, 2 Weeks, 3 Months, and 6 Months
Change in Jaw Functional Limitation Assessed by the Jaw Functional Limitation Scale-8 (JFLS-8)
Jaw functional limitation will be assessed using the 8-item Jaw Functional Limitation Scale (JFLS-8), a validated patient-reported outcome measure that evaluates limitations in mastication, jaw mobility, and verbal and emotional expression related to jaw function. Participants will complete the questionnaire at each assessment visit, and total scores will be calculated according to the instrument guidelines. Changes in JFLS-8 scores 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 jaw function and functional impairment associated with bruxism. The Jaw Functional Limitation Scale-8 (JFLS-8) is a questionnaire designed to assess the degree of mandibular dysfunction during activities such as chewing tough food, chewing chicken, eating soft food requiring no chewing, opening wide enough to drink from a cup, swallowing, yawning, talking, and smiling.
Measured: Baseline, 2 Weeks, 3 Months, and 6 Months
Change in Bruxism-Related Morning Symptoms and Parafunctional Habits Assessed by Self-Report Questionnaire
Bruxism-related morning symptoms and parafunctional habits will be assessed using a self-report questionnaire administered at each assessment visit. The questionnaire will evaluate the presence and frequency of symptoms commonly associated with bruxism, including morning jaw fatigue, jaw muscle soreness, headache upon awakening, tooth clenching, and tooth grinding behaviors. Changes in self-reported morning symptoms and parafunctional habits 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 bruxism-related symptom burden and oral parafunctional activity.
Measured: Baseline, 2 Weeks, 3 Months, and 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start20 Oct 2026 (estimated)
- Primary completion20 Dec 2026 (estimated)
- Study completion20 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for BruxismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bilecik Seyh Edebali Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07640035
- Sponsor's protocol ID
- BSEU-ONDER-002
- Status last verified
- May 2026
- First submitted
- 1 Jun 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share individual participant data is currently in place. Participant confidentiality and privacy considerations limit public data sharing.
Publications
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.
PubMed 36817026Li 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.
PubMed 38151884Manfredini 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.
PubMed 36597658Verhoeff 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.
PubMed 40312776
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Assessment of Bruxism and Treatment Response Using Digital Occlusal Analysis: A Clinical Study of Botulinum Toxin-A
- ClinicalTrials.gov ID
- NCT07640035
- Acronym / sponsor ID
- BSEU-ONDER-002
- Conditions
- Bruxism
- Keywords
- Bruxism, Digital Occlusal Analysis, Bite Force, Masseter Muscle, Occlusal Force Distribution, Botulinum Toxin Type A, Masticatory Muscle Activity, Placebo-Controlled Trial
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Bilecik Seyh Edebali UniversitesiUniversity, hospital or other
- Study start
- 20 Oct 2026 (estimated)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 20 Jul 2027 (estimated)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Bruxism is a repetitive jaw-muscle activity characterized by clenching and/or grinding of the teeth and is associated with various oral and craniofacial consequences, including tooth wear, muscle pain, headaches, and temporomandibular disorders. Recent international consensus statements define bruxism as a motor behavior rather than a disease entity, emphasizing the need for multidimensional assessment approaches.
Current diagnostic methods primarily rely on self-reported symptoms and clinical findings. However, self-reports may be affected by recall bias and limited awareness, while clinical signs often reflect cumulative tissue changes rather than ongoing functional activity. Although electromyography and polysomnography can provide objective information regarding masticatory muscle activity, their routine clinical use is limited by cost, technical complexity, and accessibility.
Digital occlusal analysis systems have emerged as promising tools for the objective evaluation of occlusal force characteristics. These technologies allow quantitative assessment of bite force distribution, occlusal timing, and force balance, potentially providing indirect information about masticatory muscle function. Despite their increasing clinical use, the role of digital occlusal analysis systems in the diagnosis and longitudinal monitoring of bruxism remains insufficiently investigated.
Botulinum Toxin-A (BTX-A) has been increasingly used for the management of bruxism because of its ability to reduce masticatory muscle activity through inhibition of acetylcholine release at the neuromuscular junction. Previous studies have demonstrated reductions in bite force and symptom severity following BTX-A treatment. However, most available studies have focused on subjective outcomes or lacked placebo-controlled designs and objective functional measurements.
This study was designed to address these gaps by investigating whether digital occlusal analysis can serve as an objective tool for evaluating bruxism and monitoring therapeutic response. The findings may contribute to the development of more objective diagnostic and follow-up strategies for bruxism while providing additional evidence regarding the functional effects of Botulinum Toxin-A treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Botulinum Toxin-A Group | Experimental | Drug: Botulinum Toxin-A injectionParticipants 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. |
| Placebo Group | Placebo comparator | Drug: Placebo (saline injection)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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum Toxin-A injectionBotulinum Toxin-A administered bilaterally into the masseter muscles at a total dose of 25 IU per muscle using a standardized three-point injection protocol. | Drug | Botulinum Toxin-A Group |
| Placebo (saline injection)0.9% sodium chloride solution administered bilaterally into the masseter muscles using the same anatomical sites and injection protocol as the experimental group. | Drug | Placebo Group |
Primary outcome
Change in Maximum Bite Force Measured by the OccluSense Digital Occlusal Analysis System
Time frame: Baseline, 2 Weeks, 3 Months, and 6 Months
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.
Change in Right/Left Occlusal Force Balance Measured by the OccluSense Digital Occlusal Analysis System
Time frame: Baseline, 2 Weeks, 3 Months, and 6 Months
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.
Change in Anterior/Posterior Occlusal Force Distribution Measured by the OccluSense Digital Occlusal Analysis System
Time frame: Baseline, 2 Weeks, 3 Months, and 6 Months
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.
Change in Occlusion Time Measured by the OccluSense Digital Occlusal Analysis System
Time frame: Baseline, 2 Weeks, 3 Months, and 6 Months
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.
Change in Disocclusion Time Measured by the OccluSense Digital Occlusal Analysis System
Time frame: Baseline, 2 Weeks, 3 Months, and 6 Months
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.
Change in Center of Force (COF) Measured by the OccluSense Digital Occlusal Analysis System
Time frame: Baseline, 2 Weeks, 3 Months, and 6 Months
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.
5 secondary outcomes
Change in Pain Intensity Assessed by the Visual Analog Scale (VAS)
Time frame: Baseline, 2 Weeks, 3 Months, and 6 Months
Change in Maximum Mouth Opening Measured in Millimeters (mm)
Time frame: Baseline, 2 Weeks, 3 Months, and 6 Months
Change in Masseter Muscle Tenderness Assessed by Clinical Examination
Time frame: Baseline, 2 Weeks, 3 Months, and 6 Months
Change in Jaw Functional Limitation Assessed by the Jaw Functional Limitation Scale-8 (JFLS-8)
Time frame: Baseline, 2 Weeks, 3 Months, and 6 Months
Change in Bruxism-Related Morning Symptoms and Parafunctional Habits Assessed by Self-Report Questionnaire
Time frame: Baseline, 2 Weeks, 3 Months, and 6 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Background: PubMed 36817026da 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.
- Background: PubMed 38151884Li 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.
- Background: PubMed 36597658Manfredini 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.
- Background: PubMed 40312776Verhoeff 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.
- Individual participant dataSharing planned: No. No plan to share individual participant data is currently in place. Participant confidentiality and privacy considerations limit public data sharing.
Related trials for Bruxism
Enrolling by invitationObservational study
The General Aim is to Implement Clinical Assessment of Overload by Voluntary Bite Force Registration to Enable Future Simple But Precise Risk Assessment to Provide Individualized Treatment Plans.
Dental Implant, Bruxism
RecruitingObservational study
Effect Of Orofacial Pain Therapy On Bruxism
Masticatory Myofascial Pain
Not yet recruiting
Influence Of Different Relaxation Techniques On Stress Level For Patients With Bruxism Using Salivary Biomarkers.
Bruxism, Stress (Psychology)
RecruitingObservational study
Orofacial Pain and Oral Health-Related Quality of Life in Musicians in German Amateur Orchestras
Orofacial Pain, Sleep Bruxism
Not yet recruitingObservational study
Bruxism Induced by Obstructive Sleep Apnoea.
Sleep Apnea Syndrome, Obstructive, Bruxism, Sleep-Related
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Botulinum Toxin-A injection in people with Bruxism, run by Bilecik Seyh Edebali Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yasemin Beliz Önder, DDS, PhD (+905532502064, ybyilmaz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Maximum Bite Force Measured by the OccluSense Digital Occlusal Analysis System (time frame: Baseline, 2 Weeks, 3 Months, and 6 Months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07640035, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.