Botulinum Toxin Administration on Masticatory Performance

Sponsor

Marmara University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05562531

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Temporomandibular Disorder Bruxism

Detailed Description

The main purpose of this study is to determine the effect of BTX-A injection on masticatory performance and nutritional status in TMD patients with bruxism.

Sub-objectives of the study;

Determination of the effect of BTX-A on masticatory performance Determination of the effect of BTX-A on pain intensity Determination of the effect of BTX-A on anthropometric measurements Determination of the effect of BTX-A on nutritional status Determination of the effect of BTX-A on anxiety status.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

30 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Evaluation of the Chewing Performance and Nutritional Status of the Patients Diagnosed With Bruxism After Botulinum Toxin Application: Follow-up Study

Actual Study Start Date :

May 1, 2022

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Outcome Measures

Primary Outcome Measures

Change from baseline in the masticatory performance at 6 months [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.
Change from baseline in the nutritional status at 6 months [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.
Change from baseline in the BMI at 6 months [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).

Secondary Outcome Measures

Change in pain intensity [6 months]
Change in muscle pain intensity was assessed using a Visual Analogue Scale (VAS) ranging from the absence of pain (score 0) to the most severe pain imaginable. The VAS consist of a line which can be presented horizontally or vertically (10 cm long) with anchor points of "no pain" and "worst possible pain". The patient will be asked to put a mark on the line that best describe the pain severity. The patients' responses' will be recorded and scored according to the VAS scale. Than, the results will be compared with the baseline, 1 month and 6 months later.
Change from baseline in the anxiety status at 6 months [6 months]
The anxiety status of patients at the baseline, 1 month, and 6 months later will be taken with Beck Anxiety Index. These scores will be recorded and compared with the baseline, 1 month and 6 months later.
Change in chewing ability [6 months]
In this study, a questionnaire consisting of open and closed-ended questions will be used to determine the chewing difficulties of individuals. With open-ended questions, foods that are difficult to chew and the methods used to consume these foods will be questioned. In the follow-up interviews, closed-ended questions such as the ability to chew the previously listed foods are "easy to chew", "I have a little difficulty", "I have a lot of difficulty / can't chew at all". If individuals say, "I have a little or a lot of difficulty" while chewing hard foods and "I have some or a lot of difficulty" when chewing soft foods, they will be evaluated as "difficulty in chewing".

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.