Botulinum Toxin Administration on Masticatory Performance
NCT ID: NCT05562531
Last Updated: 2023-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
30 participants
OBSERVATIONAL
2022-05-01
2023-12-01
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
50 Years
ALL
Yes
Sponsors
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Marmara University
OTHER
Responsible Party
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Ferit Bayram
Assist. Prof.
Locations
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Marmara University School of Dentistry
Istanbul, , Turkey (Türkiye)
Countries
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Facility Contacts
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Ferit Bayram, Ph. D.
Role: primary
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Mumcu G, Inanc N, Ergun T, Ikiz K, Gunes M, Islek U, Yavuz S, Sur H, Atalay T, Direskeneli H. Oral health related quality of life is affected by disease activity in Behcet's disease. Oral Dis. 2006 Mar;12(2):145-51. doi: 10.1111/j.1601-0825.2005.01173.x.
Nasri-Heir C, Epstein JB, Touger-Decker R, Benoliel R. What should we tell patients with painful temporomandibular disorders about what to eat? J Am Dent Assoc. 2016 Aug;147(8):667-71. doi: 10.1016/j.adaj.2016.04.016. Epub 2016 Jun 11.
Patel J, Cardoso JA, Mehta S. A systematic review of botulinum toxin in the management of patients with temporomandibular disorders and bruxism. Br Dent J. 2019 May;226(9):667-672. doi: 10.1038/s41415-019-0257-z.
Pedroni CR, De Oliveira AS, Guaratini MI. Prevalence study of signs and symptoms of temporomandibular disorders in university students. J Oral Rehabil. 2003 Mar;30(3):283-9. doi: 10.1046/j.1365-2842.2003.01010.x.
Reis JP, Macera CA, Araneta MR, Lindsay SP, Marshall SJ, Wingard DL. Comparison of overall obesity and body fat distribution in predicting risk of mortality. Obesity (Silver Spring). 2009 Jun;17(6):1232-9. doi: 10.1038/oby.2008.664. Epub 2009 Feb 5.
Slade GD. Derivation and validation of a short-form oral health impact profile. Community Dent Oral Epidemiol. 1997 Aug;25(4):284-90. doi: 10.1111/j.1600-0528.1997.tb00941.x.
Tarkowska A, Katzer L, Ahlers MO. Assessment of masticatory performance by means of a color-changeable chewing gum. J Prosthodont Res. 2017 Jan;61(1):9-19. doi: 10.1016/j.jpor.2016.04.004. Epub 2016 May 17.
Torrance GW, Feeny D, Furlong W. Visual analog scales: do they have a role in the measurement of preferences for health states? Med Decis Making. 2001 Jul-Aug;21(4):329-34. doi: 10.1177/0272989X0102100408.
Villa S, Raoul G, Machuron F, Ferri J, Nicot R. Improvement in quality of life after botulinum toxin injection for temporomandibular disorder. J Stomatol Oral Maxillofac Surg. 2019 Feb;120(1):2-6. doi: 10.1016/j.jormas.2018.10.007. Epub 2018 Oct 29.
Wewers ME, Lowe NK. A critical review of visual analogue scales in the measurement of clinical phenomena. Res Nurs Health. 1990 Aug;13(4):227-36. doi: 10.1002/nur.4770130405.
Other Identifiers
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MU_DHF_SBF_01
Identifier Type: -
Identifier Source: org_study_id