BruxismNCT07673471
Vertical Facial Morphology and Occlusal Force Changes After Masseter Botulinum Toxin Injection in Bruxism
A study testing Botulinum Toxin Type A (BOTOX) Injection in people with Bruxism and Occlusal Changes, run by Biruni University at 1 site in Turkey (Türkiye).
Trial summary
This study investigated whether the shape of the face affects how jaw muscles respond to botulinum toxin injections in people who grind their teeth (bruxism). Participants were divided into two groups based on their facial structure: low-angle (shorter face height) and normal-angle. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Bruxism, Occlusal Changes
- What is being tested?
- Botulinum Toxin Type A (BOTOX) Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Feb 2026to 8 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-40 years
- Confirmed bruxism diagnosis through self-report and clinical signs
- Full permanent dentition excluding third molars
- Angle Class I molar relationship
- No previous BTX-A injection within 6 months
- GoGn/SN angle between 18° and 38° on lateral cephalometric radiograph
Who cannot join
- Systemic neuromuscular disorders
- Known allergy to botulinum toxin or its excipients
- Pregnancy or breastfeeding
- Active infection at the injection site
- Concurrent use of medications known to interact with BTX-A
- History of orthognathic surgery or prior temporomandibular joint surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department of Orthodontics, Faculty of Dentistry, Biruni University
Istanbul, Istanbul, 34010
About this study
Official title: Influence of Vertical Facial Morphology on Occlusal Force Changes After Masseter Botulinum Toxin Injection in Bruxism: A Prospective T-Scan Study
This study investigated whether the shape of the face affects how jaw muscles respond to botulinum toxin injections in people who grind their teeth (bruxism). Participants were divided into two groups based on their facial structure: low-angle (shorter face height) and normal-angle. Each participant received botulinum toxin type A injections into the masseter (jaw) muscle. Bite force measurements were taken before and 15 days after the injection using the T-Scan computerized occlusal analysis system. The study aimed to determine whether facial structure influences the early changes in bite force balance following the injection.
- Conditions
- Bruxism, Occlusal Changes
- Being tested
- Botulinum Toxin Type A (BOTOX) Injection
- 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 Type A (BOTOX) InjectionBiological
Also called botox
Botulinum toxin type A (Botox®, Allergan, Irvine, CA, USA) was injected bilaterally into the masseter muscle at a dose of 25 units per side (50 units total per patient). Injections were performed by a single experienced clinician under sterile conditions using a 30-gauge needle.
| Study group | Role | What they receive |
|---|---|---|
| Masseter BTX-A Injection (Low-Angle and Normal-Angle Subgroups) | Experimental | Patients with bruxism received bilateral masseter muscle injections of 25 units of botulinum toxin type A (Botox®, Allergan) per side. T-Scan occlusal force measurements were performed at baseline (T0) and day 15 post-injection (T1). Participants were stratified into low-angle and normal-angle subgroups based on GoGn/SN cephalometric angle. Receives: Biological: Botulinum Toxin Type A (BOTOX) Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Center of Force (CoF)
The Center of Force (CoF) represents the geometric center of the total occlusal force distribution, measured using the T-Scan Novus™ computerized occlusal analysis system (version 10.0.40; Tekscan, Inc., South Boston, MA, USA). CoF values closer to zero indicate greater bilateral occlusal balance. Within-group changes (T0 to T1) and between-group differences were assessed and compared between low-angle (GoGn/SN < 26°) and normal-angle (GoGn/SN 26-38°) subgroups.
Measured: Baseline (T0) and day 15 post-injection (T1)
Secondary outcomes (1)
Change in Anterior and Posterior Force Percentage
Anterior force percentage is defined as the combined occlusal force distribution of the anterior teeth, and posterior force percentage as the combined force distribution of the posterior teeth. Both were measured using the T-Scan Novus™ system at baseline (T0) and day 15 post-injection (T1). Within-group changes and between-group differences in anterior-posterior force distribution were evaluated and compared between low-angle and normal-angle subgroups.
Measured: Baseline (T0) and day 15 post-injection (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start9 Feb 2026
- Primary completion8 May 2026
- Study completion8 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Macit, Biruni University
- Investigators
- Esra Agaoğlu Mogul, Study chair, Department of Orthodontics, Faculty of Dentistry, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07673471
- Sponsor's protocol ID
- BiruniU-2026-09
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to patient privacy and ethical restrictions. Data are available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Vertical Facial Morphology on Occlusal Force Changes After Masseter Botulinum Toxin Injection in Bruxism: A Prospective T-Scan Study
- ClinicalTrials.gov ID
- NCT07673471
- Acronym / sponsor ID
- BiruniU-2026-09
- Conditions
- Bruxism, Occlusal Changes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 9 Feb 2026 (actual)
- Primary completion
- 8 May 2026 (actual)
- Study completion
- 8 May 2026 (actual)
- First posted
- 29 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.
This study investigated whether the shape of the face affects how jaw muscles respond to botulinum toxin injections in people who grind their teeth (bruxism). Participants were divided into two groups based on their facial structure: low-angle (shorter face height) and normal-angle. Each participant received botulinum toxin type A injections into the masseter (jaw) muscle. Bite force measurements were taken before and 15 days after the injection using the T-Scan computerized occlusal analysis system. The study aimed to determine whether facial structure influences the early changes in bite force balance following the injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Masseter BTX-A Injection (Low-Angle and Normal-Angle Subgroups) | Experimental | Biological: Botulinum Toxin Type A (BOTOX) InjectionPatients with bruxism received bilateral masseter muscle injections of 25 units of botulinum toxin type A (Botox®, Allergan) per side. T-Scan occlusal force measurements were performed at baseline (T0) and day 15 post-injection (T1). Participants were stratified into low-angle and normal-angle subgroups based on GoGn/SN cephalometric angle. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18-40 years
- Confirmed bruxism diagnosis through self-report and clinical signs
- Full permanent dentition excluding third molars
- Angle Class I molar relationship
- No previous BTX-A injection within 6 months
Key exclusion criteria (6 listed)
- Systemic neuromuscular disorders
- Known allergy to botulinum toxin or its excipients
- Pregnancy or breastfeeding
- Active infection at the injection site
- Concurrent use of medications known to interact with BTX-A
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 Type A (BOTOX) InjectionAlso: botoxBotulinum toxin type A (Botox®, Allergan, Irvine, CA, USA) was injected bilaterally into the masseter muscle at a dose of 25 units per side (50 units total per patient). Injections were performed by a single experienced clinician under sterile conditions using a 30-gauge needle. | Biological | Masseter BTX-A Injection (Low-Angle and Normal-Angle Subgroups) |
Primary outcome
Change in Center of Force (CoF)
Time frame: Baseline (T0) and day 15 post-injection (T1)
The Center of Force (CoF) represents the geometric center of the total occlusal force distribution, measured using the T-Scan Novus™ computerized occlusal analysis system (version 10.0.40; Tekscan, Inc., South Boston, MA, USA). CoF values closer to zero indicate greater bilateral occlusal balance. Within-group changes (T0 to T1) and between-group differences were assessed and compared between low-angle (GoGn/SN < 26°) and normal-angle (GoGn/SN 26-38°) subgroups.
1 secondary outcome
Change in Anterior and Posterior Force Percentage
Time frame: Baseline (T0) and day 15 post-injection (T1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to patient privacy and ethical restrictions. Data are available from the corresponding author on reasonable request.
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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. This study is not recruiting at the moment.
Esra Agaoğlu Mogul study chair
Department of Orthodontics, Faculty of Dentistry, Biruni University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botulinum Toxin Type A (BOTOX) Injection in people with Bruxism and Occlusal Changes, run by Biruni University 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 6 inclusion and 6 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: finished, as of the sponsor's last update on 29 Jun 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Center of Force (CoF) (time frame: Baseline (T0) and day 15 post-injection (T1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jun 2026.