Effect of botulinum toxin on chewing performance in patients with jaw disorders
Evaluation of the Chewing Performance and Nutritional Status of the Patients Diagnosed With Bruxism After Botulinum Toxin Application: Follow-up Study
This study is testing if botulinum toxin injections can improve chewing ability and nutrition in people with jaw disorders who haven't found relief from other treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Marmara University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT05562531 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates how botulinum toxin type A (BTX-A) injections impact masticatory performance and nutritional status in patients suffering from temporomandibular disorders (TMD) and bruxism. It will compare baseline and post-treatment measures of chewing ability, pain intensity, nutrition, anxiety levels, and body measurements. The study specifically targets individuals who have not responded to splint treatment for at least three months and have specific dental occlusion criteria.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 50 with diagnosed bruxism or myofascial pain who have not benefited from splint therapy.
Not a fit: Patients with a history of botulinum toxin sensitivity or those with systemic neuropathies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve chewing ability and nutritional health for patients with TMD and bruxism.
How similar studies have performed: While the use of botulinum toxin for TMD and bruxism is explored in other studies, this specific approach focusing on masticatory performance is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Between 18 and 50 years old, * Male or female, * Able to communicate * Able to read and write * Volunteer to participate in the study, * At least 3 months of splint treatment and no results * Having Class 1 molar occlusion and not using removable prostheses * Marmara University, Faculty of Medicine, Department of Oral and Maxillofacial Surgery, patients diagnosed with bruxism or myofascial pain in masticatory muscles will be included in the study. Exclusion Criteria: * Sensitivity to botulinum toxin, * Have received botox treatment in the last 6 months, * Injection site infection * Pregnant or lactating women * Those with diseases that may cause systemic neuropathy such as diabetes, hypertension, kidney disease, * Those who do not want to sign the consent form, * Patients with a history of malignancy, radiotherapy or chemotherapy will be excluded from the study.
Where this trial is running
Istanbul
- Marmara University School of Dentistry — Istanbul, Turkey (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.