Botulinum Toxin Administration on Masticatory Performance

NCT05562531 | Unknown

• 1 other identifier: MU_DHF_SBF_01
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to evaluate the effect of botulinum toxin type A (BTX-A) injection on masticatory performance and nutritional status in temporomandibular disorder patients with bruxism caused by both intra-articular and extra-articular pathologies based on Research Diagnostic Criteria for temporomandibular disorders (TMD). The baseline and end masticatory performance, pain intensity, nutrition and anxiety statuses, and anthropometric measurements will be compared.

Conditions

Temporomandibular Disorder; Bruxism

Keywords

Botulinum Toxins, Type A; Mastication; Nutritional Status; Bruxism; Chewing

Outcome Measures

Primary Outcomes (3)

• Change from baseline in the masticatory performance at 6 months

  The masticatory performance of patients at the baseline, 1 month and 6 months later will be taken with a color-changeable gum, called "XYLITOL", (70x20x1 mm 3 g; Masticatory Performance Evaluating Gum XYLITOL, Lotte, Tokyo, Japan). Color changeable gum was first developed specifically to evaluate a person's masticatory performance; and it changes color as it is chewed. The gum will be chewed 60 times by the TMD patients. These values will be recorded and compared with the baseline, 1 month and 6 months later. After chewing, the gum colour will be evaluated according to the improved colour scale. Colour scale ranges from 1-10, and the masticatory performance will be evaluated as poor (1-6), normal (7-8), or good (9-10) with the improved color scale.

  6 months

• Change from baseline in the nutritional status at 6 months

  The nutritional status of patients at the baseline, 1 month, and 6 months later will be taken with 24-hour recall method. The data obtained from the 24-hour recall method will be analyzed using the "Computer Assisted Nutrition Program, Nutrition Information Systems Package Program (BEBIS)" and the amount of energy, carbohydrates, protein, fat and fiber consumed by participants will be calculated. Intake of energy, macro nutrients and fiber will be compared with the baseline, 1 month and 6 months later.

  6 months

• Change from baseline in the BMI at 6 months

  The body weight (kg) and height (m) of the patients at the baseline, and 6 months later will be taken by the researcher and noted in their files. The height of patients will be taken using a stadiometer with the nearest 0.1 cm, while each participant is standing erect against the wall with heels together touching the wall, without shoes. Body composition will be analyzed by Tanita DC-360 (Accurate Technology Co., Ltd. Tianjin, China) according to the standard procedure, and the body weight, percentage of body lean mass, and fat of the participants will be recorded. Body mass index (BMI) will be calculated using weight (in kilograms) divided by the height squared (in square meters).

  6 months

Secondary Outcomes (3)

• Change in pain intensity

  6 months

• Change from baseline in the anxiety status at 6 months

  6 months

• Change in chewing ability

  6 months

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients who applied to the Marmara University Faculty of Dentistry Department of Oral and Maxillofacial Surgery for bruxism and joint pain will be included in the study. It is aimed to invite all patients who applied to the clinic to the research.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University School of Dentistry

Istanbul, 34854, Turkey (Türkiye)

RECRUITING

Related Publications (25)

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MeSH Terms

Conditions

Temporomandibular Joint Disorders; Bruxism

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Tooth Diseases; Habits; Behavior

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof.

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: September 30, 2022
• Study Start: May 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2023
• Last Updated: December 7, 2023

Record last verified: 2023-12

Locations

TU (1)