NCT04495777

Brief Summary

Purpose: To determine the prevalence of temporomandibular disorders (TMD) in female healthcare students and to assess its association with oral parafunctions, neck pain and function. Methods: Female medical students will be included in the study on a voluntary basis using stratified sampling method according to the department they were being educated. The presence and severity of TMD will be assessed with the Fonseca's Anamnestic Index (FAI). The oral parafunctions will be self-reported with the Oral Behavior Checklist (OBC). The neck pain and function will be recorded with the Core Outcome Measure Index (COMI). A Chi-square test and Spearman correlation analysis will used for statistical analysis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 3, 2020

Completed
Last Updated

August 19, 2022

Status Verified

August 1, 2022

Enrollment Period

4 months

First QC Date

July 29, 2020

Last Update Submit

August 17, 2022

Conditions

Keywords

temporomandibularstudentsprevalenceparafunctional habitneck pain

Outcome Measures

Primary Outcomes (1)

  • Fonseca Anamnestic Index

    Fonseca Anamnestic Index was developed to assess the severity of temporomandibular disorders, based on its signs and symptoms. It has been proposed as a low cost and easy to apply alternative and has been used in screening for TMD in a non-patient population5. It was created with 10 items with 3 options of answers (specific scores): "yes (10 points)", "sometimes (5 points)" and "no (0 points)". The final score of the instrument is determined by the sum of the scores of all items, allowing the following classifications: the absence of signs and symptoms of TMD (0-15 points), mild TMD (20-45 points), moderate TMD (50-65 points), and severe TMD (70-100 points) (19).

    baseline

Secondary Outcomes (2)

  • Oral parafunction

    baseline

  • Neck pain and function

    baseline

Study Arms (1)

students

students were assessed in order to have a risk for TMD in order to their status of having parafunctional habits and neck pain

Other: Fonseca Anamnestic Index

Interventions

Fonseca Anamnestic Index was developed to assess the severity of temporomandibular disorders, based on its signs and symptoms. It has been proposed as a low cost and easy to apply alternative and has been used in screening for TMD in a non-patient population5. It was created with 10 items with 3 options of answers (specific scores): "yes (10 points)", "sometimes (5 points)" and "no (0 points)". The final score of the instrument is determined by the sum of the scores of all items, allowing the following classifications: the absence of signs and symptoms of TMD (0-15 points), mild TMD (20-45 points), moderate TMD (50-65 points), and severe TMD (70-100 points) (19).

students

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsstudents who define themselves as female are included in our study
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

University students who are currently ongoing their education in healthcare department

You may qualify if:

  • be Adnan Menderes University student
  • female gender
  • express consent to participate voluntarily in the study

You may not qualify if:

  • with recent trauma to head and face,
  • history of systematic diseases and neurological disorders
  • currently an ongoing orthodontic treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gul Oznur KARABICAK

Aydin, 09010, Turkey (Türkiye)

Location

Related Publications (23)

  • 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.

    PMID: 12588501BACKGROUND
  • Kuc J, Szarejko KD, Sierpinska T. Evaluation of Orofacial and General Pain Location in Patients With Temporomandibular Joint Disorder-Myofascial Pain With Referral. Front Neurol. 2019 May 29;10:546. doi: 10.3389/fneur.2019.00546. eCollection 2019.

    PMID: 31191438BACKGROUND
  • Schmid-Schwap M, Bristela M, Kundi M, Piehslinger E. Sex-specific differences in patients with temporomandibular disorders. J Orofac Pain. 2013 Winter;27(1):42-50. doi: 10.11607/jop.970.

    PMID: 23424719BACKGROUND
  • Nekora-Azak A, Evlioglu G, Ceyhan A, Keskin H, Berkman S, Issever H. Estrogen replacement therapy among postmenopausal women and its effects on signs and symptoms of temporomandibular disorders. Cranio. 2008 Jul;26(3):211-5. doi: 10.1179/crn.2008.028.

    PMID: 18686498BACKGROUND
  • Nomura K, Vitti M, Oliveira AS, Chaves TC, Semprini M, Siessere S, Hallak JE, Regalo SC. Use of the Fonseca's questionnaire to assess the prevalence and severity of temporomandibular disorders in Brazilian dental undergraduates. Braz Dent J. 2007;18(2):163-7. doi: 10.1590/s0103-64402007000200015.

    PMID: 17982559BACKGROUND
  • Karthik R, Hafila MIF, Saravanan C, Vivek N, Priyadarsini P, Ashwath B. Assessing Prevalence of Temporomandibular Disorders among University Students: A Questionnaire Study. J Int Soc Prev Community Dent. 2017 Jun;7(Suppl 1):S24-S29. doi: 10.4103/jispcd.JISPCD_146_17. Epub 2017 Jun 20.

    PMID: 28713764BACKGROUND
  • Lung J, Bell L, Heslop M, Cuming S, Ariyawardana A. Prevalence of temporomandibular disorders among a cohort of university undergraduates in Australia. J Investig Clin Dent. 2018 Aug;9(3):e12341. doi: 10.1111/jicd.12341. Epub 2018 Mar 31.

    PMID: 29604182BACKGROUND
  • Emel Dervis N. Prevalence of Temporomandibular Disorder in Turkish University Students: a Questionnaire Study. Balk J Dent Med. 2019; 23 (2): 80-87 doi:10.2478/bjdm-2019-0015

    BACKGROUND
  • Türken R, Büyük SK, Yaşa Y. Diş Hekimliği Fakültesi Öğrencilerinde Temporomandibular Eklem Rahatsızlıklarının ve Ağız Sağlığı Alışkanlıklarının Değerlendirilmesi. Acıbadem Üniversitesi Sağlık Bilim Derg. 2020;11(2):208-213. https://doi.org/10.31067/0.2018.83.

    BACKGROUND
  • Tanhan A, Yıldız A, Demirbüken İ, Polat MG. Sağlık Bilimleri Öğrencilerinde Temporomandibular Eklem Disfonksiyon Riskinin Araştırılması. Sak Med J. 2019. doi:10.31832/smj.490740

    BACKGROUND
  • Yalcin Yeler D, Yilmaz N, Koraltan M, Aydin E. A survey on the potential relationships between TMD, possible sleep bruxism, unilateral chewing, and occlusal factors in Turkish university students. Cranio. 2017 Sep;35(5):308-314. doi: 10.1080/08869634.2016.1239851. Epub 2016 Oct 6.

    PMID: 27707365BACKGROUND
  • Ozdinc S PhD, Ata H MSc, Selcuk H MSc, Can HB MSc, Sermenli N MSc, Turan FN PhD. Temporomandibular joint disorder determined by Fonseca anamnestic index and associated factors in 18- to 27-year-old university students. Cranio. 2020 Sep;38(5):327-332. doi: 10.1080/08869634.2018.1513442. Epub 2018 Sep 8.

    PMID: 30198391BACKGROUND
  • Ayalı A, Ramoğlu S. KUZEY KIBRIS'TA DİŞ HEKİMLİĞİ FAKÜLTESİ ÖĞRENCİLERİNDE TEMPOROMANDİBULER EKLEM DİSFONKSİYONU'NUN PREVALANSI. Atatürk Üniversitesi Diş Hekim Fakültesi Derg. 2015;24(3). doi:10.17567/dfd.91850

    BACKGROUND
  • Oliveira LK, Almeida Gde A, Lelis ER, Tavares M, Fernandes Neto AJ. Temporomandibular disorder and anxiety, quality of sleep, and quality of life in nursing professionals. Braz Oral Res. 2015;29:S1806-83242015000100265. doi: 10.1590/1807-3107BOR-2015.vol29.0070.

    PMID: 26039910BACKGROUND
  • Chatzopoulos GS, Sanchez M, Cisneros A, Wolff LF. Prevalence of temporomandibular symptoms and parafunctional habits in a university dental clinic and association with gender, age, and missing teeth. Cranio. 2019 May;37(3):159-167. doi: 10.1080/08869634.2017.1399649. Epub 2017 Nov 16.

    PMID: 29143569BACKGROUND
  • Lovgren A, Osterlund C, Ilgunas A, Lampa E, Hellstrom F. A high prevalence of TMD is related to somatic awareness and pain intensity among healthy dental students. Acta Odontol Scand. 2018 Aug;76(6):387-393. doi: 10.1080/00016357.2018.1440322. Epub 2018 Feb 18.

    PMID: 29457522BACKGROUND
  • Paduano S MD, DDS, Bucci R DDS, PhD, Rongo R DDS, PhD, Silva R DDS, Michelotti A DDS. Prevalence of temporomandibular disorders and oral parafunctions in adolescents from public schools in Southern Italy. Cranio. 2020 Nov;38(6):370-375. doi: 10.1080/08869634.2018.1556893. Epub 2018 Dec 14.

    PMID: 30547719BACKGROUND
  • Leketas M, Saferis V, Kubilius R, Cervino G, Bramanti E, Cicciu M. Oral Behaviors and Parafunctions: Comparison of Temporomandibular Dysfunction Patients and Controls. J Craniofac Surg. 2017 Nov;28(8):1933-1938. doi: 10.1097/SCS.0000000000003945.

    PMID: 28930927BACKGROUND
  • Bevilaqua-Grossi D, Chaves TC, de Oliveira AS, Monteiro-Pedro V. Anamnestic index severity and signs and symptoms of TMD. Cranio. 2006 Apr;24(2):112-8. doi: 10.1179/crn.2006.018.

    PMID: 16711273BACKGROUND
  • Al Hayek SO, Al-Thunayan MF, AlGhaihab AM, AlReshaid RM, Omair A. Assessing stress associated with temporomandibular joint disorder through Fonseca's anamnestic index among the Saudi physicians. Clin Exp Dent Res. 2018 Dec 26;5(1):52-58. doi: 10.1002/cre2.157. eCollection 2019 Feb.

    PMID: 30847233BACKGROUND
  • Mannion AF, Porchet F, Kleinstuck FS, Lattig F, Jeszenszky D, Bartanusz V, Dvorak J, Grob D. The quality of spine surgery from the patient's perspective. Part 1: the Core Outcome Measures Index in clinical practice. Eur Spine J. 2009 Aug;18 Suppl 3(Suppl 3):367-73. doi: 10.1007/s00586-009-0942-8. Epub 2009 Mar 25.

    PMID: 19319578BACKGROUND
  • Mannion AF, Porchet F, Kleinstuck FS, Lattig F, Jeszenszky D, Bartanusz V, Dvorak J, Grob D. The quality of spine surgery from the patient's perspective: part 2. Minimal clinically important difference for improvement and deterioration as measured with the Core Outcome Measures Index. Eur Spine J. 2009 Aug;18 Suppl 3(Suppl 3):374-9. doi: 10.1007/s00586-009-0931-y. Epub 2009 Mar 19.

    PMID: 19296136BACKGROUND
  • Karabicak GO, Hazar Kanik Z, Gunaydin G, Pala OO, Citaker S. Reliability and validity of the Turkish version of the Core Outcome Measures Index for the neck pain. Eur Spine J. 2020 Jan;29(1):186-193. doi: 10.1007/s00586-019-06169-w. Epub 2019 Oct 31.

    PMID: 31673855BACKGROUND

MeSH Terms

Conditions

Temporomandibular Joint DisordersNeck Pain

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gul Oznur KARABICAK, Phd

    Aydin Adnan Menderes University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 29, 2020

First Posted

August 3, 2020

Study Start

November 1, 2019

Primary Completion

March 1, 2020

Study Completion

June 1, 2020

Last Updated

August 19, 2022

Record last verified: 2022-08

Locations