Botulinum Toxin Administration on Masticatory Performance

December 6, 2023 updated by: Ferit Bayram, Marmara University

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

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Turkey
- - Istanbul, Turkey, 34854
    - Recruiting
    - Marmara University School of Dentistry
    - Principal Investigator:
      
      Şule Aktaç, Assoc. Prof.
    - Principal Investigator:
      
      Ceren Küçük, Assist. Prof.
    - Contact:
      
      Ferit Bayram, Ph. D.
      
      Phone Number: 00902167775074
      
      Email: ferit.bayram@marmara.edu.tr
    - Principal Investigator:
      
      Güleren Sabuncular, Assist. Prof.
    - Principal Investigator:
      
      Hatice Merve Bayram, Ph. D.
    - Principal Investigator:
      
      Baturay Ornağ, DDS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Case-Only
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in the masticatory performance at 6 months Time Frame: 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 Time Frame: 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 Time Frame: 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain intensity Time Frame: 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.	6 months
Change from baseline in the anxiety status at 6 months Time Frame: 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.	6 months
Change in chewing ability Time Frame: 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".	6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Actual)

October 1, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

September 22, 2022

First Submitted That Met QC Criteria

September 29, 2022

First Posted (Actual)

September 30, 2022

Study Record Updates

Last Update Posted (Estimated)

December 7, 2023

Last Update Submitted That Met QC Criteria

December 6, 2023

Last Verified