An interventional study of Botulinum Toxin Type A (BOTOX) Injection in Bruxism and Occlusal Changes, sponsored by Biruni University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-06-29.
Sponsored by Biruni University · Not applicable, Interventional, and Treatment
Among 13 studies testing botulinum toxin type A in Bruxism — 3 open to participants now, 3 under way, 1 of them phase 3. botulinum toxin type A · Bruxism.
Among the 13 studies testing botulinum toxin type A in Bruxism, this one is the 6th largest by enrollment, is one of 3 that started in 2026, is one of 6 with no phase, and was the 13th registered.
151 studies on the registry are indexed under Bruxism; 39 are open to participants now.
This study's enrollment of 34 is below the median of 39 across 94 interventional studies indexed under Bruxism.
Browse Bruxism studies →3 of the 13 studies testing botulinum toxin type A in Bruxism are open now, in 2 countries. Each count lists the studies.
botulinum toxin type A: first FDA approval 1991 (BOTOX COSMETIC), first EMA approval 2019. What it is approved for, and how studies give it, is on its page →
Of the 15 Bruxism studies recruiting now, 8 (53%) set no upper age limit and 7 (47%) stop at 75 or younger; 2 take children under 18; 8 take healthy volunteers.
This study: 18 Years to 40 Years · all sexes · no healthy volunteers.
The full table on the hub →13 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 3 started in 2026.
Median enrollment 24 across the 13 interventional studies. Of the 7 that completed or were terminated, 2 (29%) have results posted.
None of the 13 has an industry lead sponsor. The 10 most frequent:
Biruni University is the lead sponsor of 180 studies on the registry; 45 are open to participants now.
Biruni University has 1 study filed under Bruxism — fewer than ten, so there is no comparison to draw.
1 of the studies testing botulinum toxin type A in Bruxism that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07640035Bilecik Seyh Edebali UniversitesiBotulinum Toxin-A for Bruxism Using Digital Occlusal Analysis | 2026-12-20 |
Among the 13 studies testing botulinum toxin type A in Bruxism, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Biological: Botulinum Toxin Type A (BOTOX) Injection
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.
Also known as: botox
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.
Time frame: Baseline (T0) and day 15 post-injection (T1)
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.
Time frame: Baseline (T0) and day 15 post-injection (T1)
Plan to share: 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.
No publications or documents are linked to this record.
Ran from Feb 2026 to primary completion in May 2026, 2 months.
Of 59 non-industry interventional studies with no phase under Bruxism, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 13. This study's 2 months is below that.
Counting every sponsor, half of 60 studies reached it within 7 months; a quarter within 3 and three quarters within 13.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Botulinum toxin type A