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Search / Trial NCT05562531

Botulinum Toxin Administration on Masticatory Performance

Launched by MARMARA UNIVERSITY · Sep 29, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Botulinum Toxins, Type A Mastication Nutritional Status Bruxism Chewing

ClinConnect Summary

This clinical trial is studying the effects of botulinum toxin type A (often known as Botox) on improving chewing ability and overall nutrition in people who have temporomandibular disorders (TMD) and bruxism, which is when a person grinds their teeth. The researchers want to see if injecting this treatment can help reduce pain and improve how well patients can chew food. They will compare the participants' chewing ability, pain levels, nutrition, and anxiety before and after the treatment.

To be eligible for this study, participants need to be between 18 and 50 years old, have been using a dental splint for at least three months without improvement, and have certain dental conditions. They must be able to communicate effectively and provide consent to participate. Participants can expect to undergo the treatment and then have their progress monitored in terms of pain and chewing performance. It's important to note that individuals with certain medical conditions, recent Botox treatments, or those who are pregnant or breastfeeding cannot participate. This study is currently looking for volunteers at Marmara University in Turkey.

Gender

ALL

Eligibility 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.

About Marmara University

Marmara University is a distinguished academic institution located in Istanbul, Turkey, renowned for its commitment to advancing healthcare through innovative research and clinical trials. With a robust infrastructure and a multidisciplinary approach, the university actively engages in the development and evaluation of new therapeutic interventions, fostering collaboration among researchers, clinicians, and industry partners. Marmara University’s focus on ethical standards and patient safety underscores its dedication to contributing valuable insights to the medical community and improving health outcomes.

Locations

Istanbul, , Turkey

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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