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Botulinum Toxin-A for Bruxism Using Digital Occlusal Analysis

5 czerwca 2026 zaktualizowane przez: Bilecik Seyh Edebali Universitesi

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.

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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

36

Faza

  • Wczesna faza 1

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

  • Nazwa: Yasemin Beliz Önder, DDS, PhD
  • Numer telefonu: +905532502064
  • E-mail: ybyilmaz@gmail.com

Lokalizacje studiów

  • Turcja (Türkiye)
    • Bilecik
      • Bilecik, Bilecik, Turcja (Türkiye), 11100
        • Department of Periodontology, Bilecik Seyh Edebali University Faculty of Dentistry
        • Kontakt:
        • Kontakt:
          • Muhammed Emin Kalender, DDS
          • Numer telefonu: +90 546 610 78 27
          • E-mail: ybyilmaz@gmail.com
        • Główny śledczy:
          • Yasemin Beliz ÖNDER, DDS, PhD
        • Pod-śledczy:
          • Muhammed Emin Kalender, DDS, PhD
        • Pod-śledczy:
          • Taner TÜRKAY, DDS, PhD

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły

Akceptuje zdrowych ochotników

Nie

Opis

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Botulinum Toxin-A Group
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.
Lek: Botulinum Toxin-A injection
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.
Komparator placebo: Placebo Group
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.
Lek: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in Maximum Bite Force Measured by the OccluSense Digital Occlusal Analysis System
Ramy czasowe: 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.
Baseline, 2 Weeks, 3 Months, and 6 Months
Change in Right/Left Occlusal Force Balance Measured by the OccluSense Digital Occlusal Analysis System
Ramy czasowe: 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.
Baseline, 2 Weeks, 3 Months, and 6 Months
Change in Anterior/Posterior Occlusal Force Distribution Measured by the OccluSense Digital Occlusal Analysis System
Ramy czasowe: 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.
Baseline, 2 Weeks, 3 Months, and 6 Months
Change in Occlusion Time Measured by the OccluSense Digital Occlusal Analysis System
Ramy czasowe: 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.
Baseline, 2 Weeks, 3 Months, and 6 Months
Change in Disocclusion Time Measured by the OccluSense Digital Occlusal Analysis System
Ramy czasowe: 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.
Baseline, 2 Weeks, 3 Months, and 6 Months
Change in Center of Force (COF) Measured by the OccluSense Digital Occlusal Analysis System
Ramy czasowe: 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.
Baseline, 2 Weeks, 3 Months, and 6 Months

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in Pain Intensity Assessed by the Visual Analog Scale (VAS)
Ramy czasowe: Baseline, 2 Weeks, 3 Months, and 6 Months
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.
Baseline, 2 Weeks, 3 Months, and 6 Months
Change in Maximum Mouth Opening Measured in Millimeters (mm)
Ramy czasowe: Baseline, 2 Weeks, 3 Months, and 6 Months
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.
Baseline, 2 Weeks, 3 Months, and 6 Months
Change in Masseter Muscle Tenderness Assessed by Clinical Examination
Ramy czasowe: Baseline, 2 Weeks, 3 Months, and 6 Months
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.
Baseline, 2 Weeks, 3 Months, and 6 Months
Change in Jaw Functional Limitation Assessed by the Jaw Functional Limitation Scale-8 (JFLS-8)
Ramy czasowe: Baseline, 2 Weeks, 3 Months, and 6 Months
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.
Baseline, 2 Weeks, 3 Months, and 6 Months
Change in Bruxism-Related Morning Symptoms and Parafunctional Habits Assessed by Self-Report Questionnaire
Ramy czasowe: Baseline, 2 Weeks, 3 Months, and 6 Months
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.
Baseline, 2 Weeks, 3 Months, and 6 Months

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Bilecik Seyh Edebali Universitesi

Publikacje i pomocne linki

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Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

20 lipca 2026

Zakończenie podstawowe (Szacowany)

20 grudnia 2026

Ukończenie studiów (Szacowany)

20 lipca 2027

Daty rejestracji na studia

Pierwszy przesłany

1 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

5 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

10 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

10 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

5 czerwca 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • BSEU-ONDER-002

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

No plan to share individual participant data is currently in place. Participant confidentiality and privacy considerations limit public data sharing.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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