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Vertical Facial Morphology and Occlusal Force Changes After Masseter Botulinum Toxin Injection in Bruxism

Influence of Vertical Facial Morphology on Occlusal Force Changes After Masseter Botulinum Toxin Injection in Bruxism: A Prospective T-Scan Study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07673471
Enrollment
34
Registered
2026-06-29
Start date
2026-02-09
Completion date
2026-05-08
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bruxism, Occlusal Changes

Brief 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. 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.

Interventions

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.

Sponsors

Biruni University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change in Center of Force (CoF)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.

Secondary

MeasureTime frameDescription
Change in Anterior and Posterior Force PercentageBaseline (T0) and day 15 post-injection (T1)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.

Countries

Turkey (Türkiye)

Contacts

STUDY_CHAIREsra Agaoğlu Mogul

Department of Orthodontics, Faculty of Dentistry, Biruni University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 17, 2026