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Manual Therapy and Splint Therapy in Patients With Temporomandibular Dysfunction

22 de abril de 2022 atualizado por: Süreyya DAMAR ÖRENLER, Turkoglu Dr. Kemal Beyazit State Hospital

Investigation of the Effectiveness of Manual Therapy and Splint Therapy in Patients With Myofascial Temporomandibular Dysfunction Combined With Bruxism

The aim of this study was to compare the efficacy of splint treatment and manual therapy in patients diagnosed with myofascial temporomandibular dysfunction with bruxism.

Visão geral do estudo

Descrição detalhada

A total of 56 patients were evaluated. Among those, 20 patients who did not meet the criteria were excluded. 36 patients met the inclusion criteria and were willing to participate in the study.

The patients were randomly separated into two groups using the method of single- and double-digit numbers written on paper in a sealed envelope.

Those who selected a double-digit number were assigned to the manual therapy (MT) group (n:18) and those with a single-digit number to the splint therapy (ST) group (n:18).

After the further exclusion of 7 patients during the treatment period, the final evaluations were compared of 29 patients (15 MT and 14 ST) who completed the 4-week treatment process.

Tipo de estudo

Intervencional

Inscrição (Real)

36

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

      • Kahramanmaraş, Peru
        • Türkoğlu Dr. Kemal Beyazıt State Hospital

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 50 anos (Adulto)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Fêmea

Descrição

Inclusion Criteria:

  • Ages between 18 and 50 years old,
  • Patients with a diagnosis of myofascial TMD with Bruxism according to the diagnostic criteria for temporomandibular disorders (DC/TMD),
  • Having pain severity ≥3 according to the Visual analogue scale (VAS),
  • Probable sleep bruxism according to clinical evaluation and a questionnaire-based assessment.

Exclusion Criteria:

  • Patients with a diagnosis other than myofascial TMD according to the research DC/TMD,
  • a history of surgery associated with cervical and/or TMJ problems,
  • a proven specific pathological condition such as cervical and/or TMJ malignancy, fracture, or systemic rheumatoid disease,
  • a history of facial paralysis, a diagnosed psychiatric disease,
  • if they were undergoing orthodontic treatment,
  • had received physiotherapy within the last 3 months,
  • or could not be co-operative.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Manual Therapy Group
Manual Therapy combined with education and home exercises

Patient education directed at parafunctional behaviors was given, and an exercise program was taught, with all the patients instructed to perform these exercises at home. The home exercise program included diaphragmatic breathing exercises, chin-tuck exercises, mandibular resistance exercises, and neck muscle stretching exercises. The patients were instructed to perform the exercises as 3 sets of 10 repetitions per day.

In addition to the patient education and home exercises, the Manual Therapy group received a manual therapy program applied as 2 sessions of 45 mins each week for 4 weeks (total 8 sessions) by an investigator. Soft tissue and joint mobilizations were applied to the TMJ and surrounding structures and to cervical segments, trigger point treatment was applied to trigger points, and myofascial loosening was performed. Patients were instructed to perform the exercises learned in the home exercise program in 3 sets of 10 repetitions every day.

Experimental: Splint Therapy Group
Splint Therapy combined with education and home exercises

Patient education directed at parafunctional behaviors was given, and an exercise program was taught, with all the patients instructed to perform these exercises at home. The home exercise program included diaphragmatic breathing exercises, chin-tuck exercises, mandibular resistance exercises, and neck muscle stretching exercises. The patients were instructed to perform the exercises as 3 sets of 10 repetitions per day.

In addition to the patient education and home exercises, the Splint Therapy group was given a static occlusal splint, and adjustments were made as necessary. All the patients in this group were instructed to use the splint when sleeping for a period of one month.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change from Baseline in Pain severity at 4 weeks
Prazo: Baseline, 4 weeks
Pain severity was measured with a Visual Analogue Scale (VAS), marked from 0 to 10, where 0 indicates no pain and 10 indicates intolerable pain. The patients were instructed to mark the scale corresponding to the severity of pain felt.
Baseline, 4 weeks
Change frim Baseline in Fatigue severity at 4 weeks
Prazo: Baseline, 4 weeks
Fatigue level was measured with the Fatigue Severity Scale, where patients were asked to indicate their levels of agreement with a 0-7 scale indicating "0" strong disagreement and "7" strong agreement at a total of 9 questions. A sum of all responses was calculated for analysis. Sixty-three was the maximum score. The higher value represented a higher level of fatigue.
Baseline, 4 weeks
Change from Baseline in Sleep quality at 4 weeks
Prazo: Baseline, 4 weeks
The sleep quality of patients was analyzed with the Pittsburgh Sleep Quality Index (PSQI). The PSQI includes 24 items related to both daytime and nocturnal sleep. The responses were scored from 0-3, as 7 subscores to give a global score of total points in the range of 0-21. A score of ≥5 indicated poor sleep quality.
Baseline, 4 weeks
Change from Baseline in Jaw Function limitation at 4 weeks
Prazo: Baseline, 4 weeks
Jaw function limitation was measured by the Jaw Functional Limitation Scale-20 (JFLS-20) where the patients asked for from 1 to 10 points per item (higher scores indicate worse jaw function). The JFLS-20 has 3 subscales: Mastication (6 items), Vertical Jaw Mobility (4 items), and Emotional and Verbal Expression (10 items).
Baseline, 4 weeks
Change from Baseline in Neck Disability at 4 weeks
Prazo: Baseline, 4 weeks
Neck Disability Index, consists of 10 items. Individuals included in the study were asked to give a score between 0 (no disability) and 5 (complete disability) for each item. The total score varies between 0 (no disability) and 50 (complete disability).
Baseline, 4 weeks
Change from Baseline in Patient Satisfaction questionnaire at 4 weeks.
Prazo: Baseline, 4 weeks
The Patient Satisfaction questionnaire was used to assess the patient's satisfaction with the treatment received. The patient satisfaction questionnaire (PSQ) contains 18 items tapping each of the seven dimensions of satisfaction with medical care measured by the PSQ-18.
Baseline, 4 weeks
Change from Baseline in Headache severity at 4 weeks
Prazo: Baseline, 4 weeks
The Headache Impact Test-6 (HIT-6) was used to assess the headache. The 6-item scale evaluates the frequency, the degree of restriction to daily life and social life, and changes in the mood. The total score of 50-59 reflects the important impact, and scores ≥60 indicate severe impact.
Baseline, 4 weeks

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change from Baseline in Head Posture at 4 weeks
Prazo: Baseline, 4 weeks
Head posture is defined as the craniovertebral angle. It is the angle formed by the intersection of a horizontal line along the spinous process of C7 and the line drawn towards the ear tragus. A craniovertebral angle of <48-50° is accepted as an anterior tilt of the head.
Baseline, 4 weeks
Change from Baseline in Cervical Range of Motion at 4 weeks
Prazo: Baseline, 4 weeks
A goniometer was used to measure the cervical region's range of motion (ROM). Cervical region flexion, extension, right-left lateral flexion, and right-left rotation degrees were measured and recorded.
Baseline, 4 weeks
Change from Baseline in Temporomandibular Joint Range of Motion at 4 weeks
Prazo: Baseline, 4 weeks
For maximal mouth opening, the distance between the upper and lower incisors was measured and recorded. For protrusion, the distance between the lower and upper incisors was measured horizontally by asking the patient to bring the lower jaw forward as far as possible while the posterior teeth were in contact with each other. For right and left lateral shifts, the distance between the upper and lower incisors was measured by asking the patient to slide it to the right and left separately as much as possible.
Baseline, 4 weeks
Change from Baseline in Trigger points at 4 weeks
Prazo: Baseline, 4 weeks
While the participants were in the supine position the masseter, temporalis, pyterigoideus lateralis, pyterigoideus medialis, and digastric muscles were evaluated. In the sitting position, the sternoclavicular, suboccipital, and upper trapezius muscles were palpated, and the trigger points in these muscles and their number were evaluated.
Baseline, 4 weeks

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Diretor de estudo: Aysenur Tuncer, Hasan Kalyoncu University

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

21 de janeiro de 2019

Conclusão Primária (Real)

28 de fevereiro de 2020

Conclusão do estudo (Real)

27 de julho de 2020

Datas de inscrição no estudo

Enviado pela primeira vez

18 de abril de 2022

Enviado pela primeira vez que atendeu aos critérios de CQ

22 de abril de 2022

Primeira postagem (Real)

28 de abril de 2022

Atualizações de registro de estudo

Última Atualização Postada (Real)

28 de abril de 2022

Última atualização enviada que atendeu aos critérios de controle de qualidade

22 de abril de 2022

Última verificação

1 de abril de 2022

Mais Informações

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Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

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