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Temporomandibular DisorderNCT05562531

Botulinum Toxin Administration on Masticatory Performance

An observational study of Temporomandibular Disorder and Bruxism, run by Marmara University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Temporomandibular Disorder, Bruxism
How many people
30 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 May 2022to 1 Dec 2023
How long will I take part?
6 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site, 1 recruiting

  • Marmara University School of Dentistry

    Istanbul, 34854

    Ferit Bayram, Ph. D., 00902167775074, ferit.bayram@marmara.edu.tr

    Güleren Sabuncular, Assist. Prof.

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Keywords
Botulinum Toxins, Type A, Mastication, Nutritional Status, Bruxism, Chewing
Medical subject headings
Temporomandibular Joint Disorders, Bruxism

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months

  2. 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.

    Measured: 6 months

  3. 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).

    Measured: 6 months

Secondary outcomes (3)

  1. Change in pain intensity

    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.

    Measured: 6 months

  2. Change from baseline in the anxiety status at 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.

    Measured: 6 months

  3. Change in chewing ability

    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".

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2022
  2. Study start1 May 2022
  3. Primary completion1 Oct 2023
  4. Study completion1 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
30 participants (estimated)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT05562531
Sponsor's protocol ID
MU_DHF_SBF_01
Status last verified
Dec 2023
First submitted
22 Sep 2022
Last updated
7 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol. 1988 Dec;56(6):893-7. doi: 10.1037//0022-006x.56.6.893. No abstract available.

    PubMed 3204199

  • Chisnoiu AM, Picos AM, Popa S, Chisnoiu PD, Lascu L, Picos A, Chisnoiu R. Factors involved in the etiology of temporomandibular disorders - a literature review. Clujul Med. 2015;88(4):473-8. doi: 10.15386/cjmed-485. Epub 2015 Nov 15.

    PubMed 26732121

  • Resende CMBM, Rocha LGDDS, Paiva RP, Cavalcanti CDS, Almeida EO, Roncalli AG, Barbosa GAS. Relationship between anxiety, quality of life, and sociodemographic characteristics and temporomandibular disorder. Oral Surg Oral Med Oral Pathol Oral Radiol. 2020 Feb;129(2):125-132. doi: 10.1016/j.oooo.2019.10.007. Epub 2019 Nov 26.

    PubMed 31784398

  • Edwards DC, Bowes CC, Penlington C, Durham J. Temporomandibular disorders and dietary changes: A cross-sectional survey. J Oral Rehabil. 2021 Aug;48(8):873-879. doi: 10.1111/joor.13210. Epub 2021 Jun 11.

    PubMed 34031904

  • Haefeli M, Elfering A. Pain assessment. Eur Spine J. 2006 Jan;15 Suppl 1(Suppl 1):S17-24. doi: 10.1007/s00586-005-1044-x. Epub 2005 Dec 1.

    PubMed 16320034

  • Haketa T, Kino K, Sugisaki M, Amemori Y, Ishikawa T, Shibuya T, Sato F, Yoshida N. Difficulty of food intake in patients with temporomandibular disorders. Int J Prosthodont. 2006 May-Jun;19(3):266-70.

    PubMed 16752624

  • Hama Y, Kanazawa M, Minakuchi S, Uchida T, Sasaki Y. Properties of a color-changeable chewing gum used to evaluate masticatory performance. J Prosthodont Res. 2014 Apr;58(2):102-6. doi: 10.1016/j.jpor.2013.12.005. Epub 2014 Jan 23.

    PubMed 24461959

  • Kamiyama M, Kanazawa M, Fujinami Y, Minakuchi S. Validity and reliability of a Self-Implementable method to evaluate masticatory performance: use of color-changeable chewing gum and a color scale. J Prosthodont Res. 2010 Jan;54(1):24-8. doi: 10.1016/j.jpor.2009.08.001.

    PubMed 19837023

  • Kaynak BA, Tas S, Salkin Y. The accuracy and reliability of the Turkish version of the Fonseca anamnestic index in temporomandibular disorders. Cranio. 2023 Jan;41(1):78-83. doi: 10.1080/08869634.2020.1812808. Epub 2020 Aug 25.

    PubMed 32840464

  • Kim HS, Yun PY, Kim YK. A clinical evaluation of botulinum toxin-A injections in the temporomandibular disorder treatment. Maxillofac Plast Reconstr Surg. 2016 Jan 28;38(1):5. doi: 10.1186/s40902-016-0051-7. eCollection 2016 Dec.

    PubMed 26855937

  • Komino M, Shiga H. Changes in mandibular movement during chewing of different hardness foods. Odontology. 2017 Oct;105(4):418-425. doi: 10.1007/s10266-016-0292-z. Epub 2017 Feb 1.

    PubMed 28150182

  • Kwon KH, Shin KS, Yeon SH, Kwon DG. Application of botulinum toxin in maxillofacial field: part I. Bruxism and square jaw. Maxillofac Plast Reconstr Surg. 2019 Oct 1;41(1):38. doi: 10.1186/s40902-019-0218-0. eCollection 2019 Dec.

    PubMed 31649901

  • Lee CM, Huxley RR, Wildman RP, Woodward M. Indices of abdominal obesity are better discriminators of cardiovascular risk factors than BMI: a meta-analysis. J Clin Epidemiol. 2008 Jul;61(7):646-53. doi: 10.1016/j.jclinepi.2007.08.012. Epub 2008 Mar 21.

    PubMed 18359190

  • Lee WK, Bae JH, Hu KS, Kato T, Kim ST. Anatomical recommendations for safe botulinum toxin injection into temporalis muscle: a simplified reproducible approach. Surg Radiol Anat. 2017 Mar;39(3):263-269. doi: 10.1007/s00276-016-1739-1. Epub 2016 Sep 8.

    PubMed 27631881

  • Monteiro DR, Zuim PR, Pesqueira AA, Ribeiro Pdo P, Garcia AR. Relationship between anxiety and chronic orofacial pain of temporomandibular disorder in a group of university students. J Prosthodont Res. 2011 Jul;55(3):154-8. doi: 10.1016/j.jpor.2010.11.001. Epub 2010 Nov 26.

    PubMed 21112271

Questions about this trial

What is this clinical trial studying?

An observational study of Temporomandibular Disorder and Bruxism, run by Marmara University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in the masticatory performance at 6 months (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05562531, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2023.

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