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Temporomandibular Joint DysfunctionNCT04435951

The Effect Of Temporomandibular Joint Dysfunction On Pain, Quality Of Life And Psychological Status

An observational study of Temporomandibular Joint Dysfunction, run by Hacettepe University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study was to investigate the effects of temporomandibular joint dysfunction (TMJD) on pain, quality of life and psychological status. A total of one hundred twenty people participated in the study, sixty with TMJD symptoms (according to the Research Diagnostic Criteria for Temporomandibular Disorders)… Read more about this study

Who is it for?
Ages 17 to 57 yearsHealthy volunteers can take part
Conditions the study is for
Temporomandibular Joint Dysfunction
What is being tested?
Evaluation
How many people
120 participants
Where
1 siteTurkey (Türkiye)
Study dates
6 Mar 2017to 25 May 2020
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 17 to 57 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Study population: Group 1 (60 patients, group with TMJD) consists of patients diagnosed with TMJD according to the Research Diagnostic Criteria for Temporomandibular Disorders by a specialist and experienced dentist in TMJD. Group 2 (60 healthy individuals, group without TMJD) consists of individuals who are evaluated by a specialist and experienced dentist in TMJD and who do not show symptoms of TMJD.

Who may be able to join

  • For Group 1 (group with TMJD):
  • Patients diagnosed with TMJD
  • Able to understand and speak Turkish and cooperate
  • Aged 17 years or older and 65 years or younger
  • Patients have articular sounds in the form of clicks or crepitation from the TMJ during mouth opening or chewing
  • Sensitivity and pain in the TMJ at palpation
Show all 13Show fewer
  • Not receiving TMJ treatment in the past six months
  • Presence of TMJD symptoms for at least three months For Group 2 (group without TMJD)
  • Able to understand and speak Turkish and cooperate
  • Aged 17 years or aged 17 years or older and 65 years or younger
  • Maximum mouth opening 30 mm or more
  • Absence of articular sounds such as TMJ click or crepitation during mouth opening and closing and/or chewing activity.
  • Absence of tenderness and pain in the TMJ and chewing muscles at palpation

Who cannot join

  • For Group 1 (group with TMJD):
  • Absence of at least one of the TMJD symptoms
  • Presence of a history of tumor, cervical discopathy, orthopedic and rheumatic pathologies, head, neck and/or jaw surgery and pregnancy For Group 2 (group without TMJD)
  • Presence of at least one of the symptoms of TMJD
  • Presence of a history of tumor, cervical discopathy, orthopedic and rheumatic pathologies, head, neck and/or jaw surgery and pregnancy

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ankara Yıldırım Beyazıt University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation

    Ankara, 06100

Other trials in Turkey (Türkiye)

About this study

The aim of this study was to investigate the effects of temporomandibular joint dysfunction (TMJD) on pain, quality of life and psychological status.

A total of one hundred twenty people participated in the study, sixty with TMJD symptoms (according to the Research Diagnostic Criteria for Temporomandibular Disorders) and sixty without TMJD symptoms. The severity of temporomandibular joint (TMJ) pain and headache was assessed using a visual analog scale (VAS), pain threshold using an algometer, anxiety and depression levels with the Hospital Anxiety and Depression Scale (HADS), and the quality of life level was assessed by Short Form-36 (SF-36).

Treatment of TMJD with appropriate therapies and psychological support techniques may reduce TMJD symptoms and improve patients' quality of life and psychological status.

Read the detailed description

Temporomandibular joint dysfunction (TMJD) occurs as a result of the impaired functioning of the structures of the masticatory system. This disruption affects the chewing muscles, temporomandibular joint (TMJ), and related structures around the joint. TMJD can produce signs and symptoms, including pain in the TMJ and chewing muscles, restricted mouth opening, and articular sounds such as clicking and/or crepitus. Other symptoms include TMJ pain, limitation in joint movements, difficulty in chewing, jaw locking (trismus), lateral deviation of the jaw, tenderness in the TMJ and chewing muscles, tinnitus and pain, dizziness, and head and neck pain.

However, to the best of the investigator's knowledge, no previous studies have examined the relationship between quality of life, pain, and psychological status in individuals with TMJD. This study was designed to investigate whether a relationship between pain, quality of life, and psychological status in individuals with TMJD and asymptomatic individuals without TMJD.

One hundred twenty individuals were included in this study performed between March and July 2017 at the Gazi University and Ankara Yıldırım Beyazıt University Dentistry Faculties, Turkey. The research was designed as a controlled, observational, cross-sectional study. Sixty of the 165 individuals presenting with TMJD symptoms were diagnosed with TMJD by a specialist dentist, and those meeting the inclusion criteria were enrolled in the first group. Sixty individuals who met the inclusion criteria out of 143 individuals who did not exhibit TMJD symptoms were enrolled in the second group. These two groups were established based on clinical and radiological examination results. TMJD was diagnosed by professional and experienced dentists using the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD). RDC/TMD has been described as the gold standard physical examination method in the clinical diagnosis of TMD.

Individuals agreeing to take part in the study were included after signing informed consent forms. Ethical committee permission was granted by the Ankara Yıldırım Beyazıt University Social and Humanities Ethics Committee (date: 02.08.2016, no: 356).

Individuals who were able to understand and speak Turkish and cooperate, and aged 17 years or older were included in the study.

Inclusion criteria for Group 1 were articular sounds in the form of clicks or crepitation from the TMJ during mouth opening or chewing, sensitivity and pain in the TMJ at palpation, no treatment for the TMJ in the previous six months, and presence of TMJD symptoms for at least three months. Inclusion criteria for Group 2, maximum mouth opening exceeding 30 mm, absence of articular sounds such as TMJ click or crepitation during mouth opening and closing and/or chewing activity, and absence of tenderness and pain in the TMJ and chewing muscles at palpation.

Exclusion criteria for Group 1 were the absence of at least one of the TMJD symptoms, absence of diagnosis of TMJD and the presence of a history of tumor, cervical discopathy, orthopedic and rheumatic pathologies, head, neck and/or jaw surgery and pregnancy.

Exclusion criteria for Group 2 were the presence of at least one of the symptoms of TMJD, the presence of a history of tumor, cervical discopathy, orthopedic and rheumatic pathologies, head, neck and/or jaw surgery, and pregnancy.

G * Power (V.3.1.9.2, Germany) software was used to calculate the sample size. Analyses were performed to investigate significant differences in the pressure pain threshold (PTT), quality of life, and psychological evaluation results between the groups (α = 0.05 and β = 0.20). The analysis showed that at least 19 individuals in each group and at least 38 individuals in total would be sufficient.

Socio-demographic (age, sex, height, weight, educational status) and clinical data (history of bruxism, dominant side, side of the problem, duration of symptoms, dominant chewing side, sleeping position, tinnitus/pain, chewing difficulty, and parafunctional oral habits status) of individuals meeting the inclusion criteria were recorded onto an evaluation form.

Individuals in both groups were asked to mark TMJ pain and headache on a 10 cm straight line using a visual analog scale (VAS), and the results were recorded in cm. Patients were asked about pain in bilateral resting and mobile positions of the TMJ. On the VAS scale, "0" indicates no pain, and "10" the most severe pain possible.

Muscle sensitivity was measured using an algometer (Baseline® dolorimeter/algometer, Pain Diagnosis, and Treatment Inc., Great Neck, NY, USA). The algometer is pressed gradually to the area where the sensitivity is to be measured, and the measurement is terminated as soon as the subject experiences pain. The PPTs of the anterior part of the temporalis muscle, the TMJ lateral capsule, and the masseter muscle were measured in the present study. Measurements were performed three times at 30-second intervals on both right and left sides. The mean values of the three measurements were recorded. PPT is defined as the lowest pressure force required to be applied to the tissue for the pain to occur. Results are expressed as kg/cm2.

The Hospital Anxiety and Depression Scale (HADS) was used to measure participants' anxiety and depression levels. The HADS scale was developed by Zigmond and Snaith and contains 14, with two sub-scales, one of seven questions (odd numbers) measuring anxiety, and another of seven questions (even numbers) measuring depression. Aydemir et al. conducted the Turkish validity and reliability study of HADS. Each question is scored between 0 and 3. The lowest possible scores for the depression and anxiety subscales were 0, and the maximum possible scores were 21. Subjects' depression and anxiety status are evaluated as normal/no symptoms (0-7 points), borderline abnormal/suspicious (8-10 points), and abnormal/definite (11-21 points), depending on the scores obtained.

Short Form-36 (SF-36) was used to assess the quality of life. Ware et al. developed the SF-36 in 1987 to determine overall health-related life quality. The scale consists of 36 questions and evaluates life quality in the previous four weeks in eight subscales and two main components. The subscales are; Physical Function (PF), Role Difficulty-Physical (RP), Body Pain (BP), General Health (GH), Vitality (V), Social Function (SF), Role Difficulty-Emotional (RE), and Mental Health (MH), while the main components are Physical Component Score (PCS) and Mental Component Score (MCS). The eight subscales assess health from 0 to 100 points. "0" indicates that health-related quality of life is poor, and 100 indicates the best possible quality of life, so higher scores indicate better quality of life. SF-36 was translated into Turkish by Koçyiğit et al. and has been subjected to validity and reliability studies.

The distributions of continuous variables such as age, body mass index (BMI), and SF-36 scores were examined using the Shapiro-Wilk test and normality graphs. Mean ± standard deviation (mean ± sd) and median (min-max: minimum-maximum) were used to express all continuous variables, while results for categorical variables such as gender and occupation were expressed as percentages (%). The independent samples t-test and Mann-Whitney U test were applied to determine the distribution of continuous variables such as SF-36 and HADS scores between groups 1 and 2. The relationship between the scale scores and pain threshold and pain severity was analyzed using Pearson and Spearman correlation analysis. The consistency of responses to SF-36 and HADS was examined using Cronbach's alpha coefficient. Statistical significance was set at p <0.05. All statistical analyses and calculations were performed on IBM SPSS Statistics 21.0 software (IBM Corp. Released 2012. IBM SPSS Statistics for Windows, Armonk, NY: IBM Corp., USA).

Being tested
Evaluation
Keywords
Temporomandibular joint, Dysfunction, Pain, Quality of life
Medical subject headings
Temporomandibular Joint Disorders, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EvaluationOther

    No attempt was made to the individuals in Group 1 and Group 2. Individuals were only evaluated.

Study groups in NCT04435951
Study groupRoleWhat they receive
Group 1 (with TMJD)Group 1, consists of 60 patients diagnosed with Temporomandibular Joint Dysfunction (TMJD) according to the Research Diagnostic Criteria for Temporomandibular Disorders by a specialist and experienced dentist in TMJD.
Receives: Other: Evaluation
Group 2 (without TMJD)Group 2, consists of 60 individuals who did not exhibit TMJD symptoms and have not TMJD diagnosis.
Receives: Other: Evaluation

What is being measured

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

  1. Temporomandibular joint pain severity and headache severity

    Individuals in both groups were asked to mark TMJ pain and headache on a 10 cm straight line using a visual analogue scale (VAS), and the results were recorded in cm. Patients were asked about pain in bilateral resting and mobile positions of the TMJ. On the VAS scale, "0" indicates no pain, and "10" the most severe pain possible.

    Measured: 5 months

Secondary outcomes (2)
  1. Psychological status (anxiety and depression levels)

    The Hospital Anxiety and Depression Scale (HADS) was used to measure participants' anxiety and depression levels. Each question was scored between 0 and 3. The lowest possible scores for the depression and anxiety subscales were 0, and the maximum possible scores were 21. Subjects' depression and anxiety status was evaluated as normal/no symptoms (0-7 points), borderline abnormal/suspicious (8-10 points) and abnormal/definite (11-21 points), depending on the scores obtained.

    Measured: 5 months

  2. Short Form-36

    Short Form-36 (SF-36) was used to assess health-related quality of life. The scale consists of 36 questions and evaluates life quality in the previous four weeks in eight subscales and two main components. The eight subscales assess health from 0 to 100 points. "0" indicates that health-related quality of life is poor, and 100 indicates the best possible quality of life, so higher scores indicate better quality of life.

    Measured: 5 months

Timeline

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

  1. First posted17 Jun 2020
  2. Study start6 Mar 2017
  3. Primary completion24 Jul 2017
  4. Study completion25 May 2020

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
Other
Time perspective
Cross-sectional
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04435951
Sponsor's protocol ID
Hacettepe FTR
Status last verified
Jun 2020
First submitted
5 Jun 2020
Last updated
17 Jun 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Vedolin GM, Lobato VV, Conti PC, Lauris JR. The impact of stress and anxiety on the pressure pain threshold of myofascial pain patients. J Oral Rehabil. 2009 May;36(5):313-21. doi: 10.1111/j.1365-2842.2008.01932.x. Epub 2009 Feb 6.

    PubMed 19210679
  • Barbosa Tde S, Miyakoda LS, Pocztaruk Rde L, Rocha CP, Gaviao MB. Temporomandibular disorders and bruxism in childhood and adolescence: review of the literature. Int J Pediatr Otorhinolaryngol. 2008 Mar;72(3):299-314. doi: 10.1016/j.ijporl.2007.11.006. Epub 2008 Jan 3.

    PubMed 18180045
  • 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
  • Suvinen TI, Hanes KR, Gerschman JA, Reade PC. Psychophysical subtypes of temporomandibular disorders. J Orofac Pain. 1997 Summer;11(3):200-5.

    PubMed 9610309
  • Wright AR, Gatchel RJ, Wildenstein L, Riggs R, Buschang P, Ellis E 3rd. Biopsychosocial differences between high-risk and low-risk patients with acute TMD-related pain. J Am Dent Assoc. 2004 Apr;135(4):474-83. doi: 10.14219/jada.archive.2004.0213.

    PubMed 15127871
  • Suvinen TI, Reade PC, Kemppainen P, Kononen M, Dworkin SF. Review of aetiological concepts of temporomandibular pain disorders: towards a biopsychosocial model for integration of physical disorder factors with psychological and psychosocial illness impact factors. Eur J Pain. 2005 Dec;9(6):613-33. doi: 10.1016/j.ejpain.2005.01.012.

    PubMed 15978854
  • Gameiro GH, da Silva Andrade A, Nouer DF, Ferraz de Arruda Veiga MC. How may stressful experiences contribute to the development of temporomandibular disorders? Clin Oral Investig. 2006 Dec;10(4):261-8. doi: 10.1007/s00784-006-0064-1. Epub 2006 Aug 22.

    PubMed 16924558
  • Krogstad BS, Jokstad A, Dahl BL, Vassend O. Relationships between risk factors and treatment outcome in a group of patients with temporomandibular disorders. J Orofac Pain. 1996 Winter;10(1):48-53.

    PubMed 8995916
  • Rocha CO, Peixoto RF, Resende CM, Alves AC, Oliveira AG, Barbosa GA. Psychosocial aspects and temporomandibular disorders in dental students. Quintessence Int. 2017;48(3):241-249. doi: 10.3290/j.qi.a37128.

    PubMed 27834414
  • Dahlstrom L, Carlsson GE. Temporomandibular disorders and oral health-related quality of life. A systematic review. Acta Odontol Scand. 2010 Mar;68(2):80-5. doi: 10.3109/00016350903431118.

    PubMed 20141363
  • Schierz O, John MT, Reissmann DR, Mehrstedt M, Szentpetery A. Comparison of perceived oral health in patients with temporomandibular disorders and dental anxiety using oral health-related quality of life profiles. Qual Life Res. 2008 Aug;17(6):857-66. doi: 10.1007/s11136-008-9360-3. Epub 2008 Jun 4.

    PubMed 18523867
  • Barros Vde M, Seraidarian PI, Cortes MI, de Paula LV. The impact of orofacial pain on the quality of life of patients with temporomandibular disorder. J Orofac Pain. 2009 Winter;23(1):28-37.

    PubMed 19264033
  • Bair MJ, Wu J, Damush TM, Sutherland JM, Kroenke K. Association of depression and anxiety alone and in combination with chronic musculoskeletal pain in primary care patients. Psychosom Med. 2008 Oct;70(8):890-7. doi: 10.1097/PSY.0b013e318185c510. Epub 2008 Sep 16.

    PubMed 18799425
  • Silva AA Jr, Brandao KV, Faleiros BE, Tavares RM, Lara RP, Januzzi E, Carvalho AB, Carvalho EM, Gomes JB, Leite FM, Alves BM, Gomez RS, Teixeira AL. Temporo-mandibular disorders are an important comorbidity of migraine and may be clinically difficult to distinguish them from tension-type headache. Arq Neuropsiquiatr. 2014 Feb;72(2):99-103. doi: 10.1590/0004-282X20130221.

    PubMed 24604361
  • 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.

    PubMed 26039910

Questions about this trial

What is this clinical trial studying?

An observational study of Temporomandibular Joint Dysfunction, run by Hacettepe 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 13 inclusion and 5 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: finished, as of the sponsor's last update on 17 Jun 2020. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Temporomandibular joint pain severity and headache severity (time frame: 5 months). 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 NCT04435951, which also lists 42 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 17 Jun 2020.

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