Skip to main content
OpenTrials
Completed

NCT Number: NCT06034769

Oral and Jaw Health in Bipolar Patients

The assessment of oral health, jaw health and related problems in bipolar patients is important to provide a holistic approach to patients in terms of physical, mental and psychosocial aspects and to improve quality of life. In this study, oral health, temporomandibular dysfunction (TMD) and oropharyngeal dysphagia (OD) were investigated in patients with Bipolar Disorder (BD).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bipolar Disorders Bipolar Disorder Bipolar and Related Disorders Craniomandibular Disorders Jaw Diseases Joint Diseases Mandibular Diseases Mental Disorders Mood Disorders Muscular Diseases Musculoskeletal Diseases Oral Health Stomatognathic Diseases Temporomandibular Joint Disorders

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bakırkoy Prof. Dr. Mazhar Osman Mental Health and Neurological Diseases Training and Research Hospital

Istanbul, Turkey (Türkiye)

About this study

During the remission period, 70 individuals aged 20-60 years with BD were divided into two groups according to the duration of diagnosis as under ten years (Group 1=33) and over ten years (Group 2=37). Oral and dental health-related quality of life was assessed with the Oral Health Impact Profile-14 (OHIP-14), TMJ pain was assessed with the Numeric Pain Scale (NPS), the presence of TMJ discomfort was assessed with the Fonseca Anamnestic Questionnaire (FAQ), chewing functionality was assessed with the Jaw Function Limitation Scale-8 (JFLS-8), and oropharyngeal dysphagia was assessed with the Eating Assessment Tool (EAT-10).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients between 20 and 60 years of age who volunteered to participate in the study and signed the informed consent form,
  • diagnosed with BD at the outpatient department of Bakırkoy Prof. Dr. Mazhar Osman Mental Health and Neurological Diseases Training and Research Hospital,
  • in remission for at least 3 months,
  • had a history of regular lithium use for at least 1 year in any phase of the disease were included in the study.

Exclusion criteria

  • being in a manic or depressive episode (Young Mania Rating Scale score greater than 7, Hamilton Depression Rating Scale score greater than 7)
  • history of comorbid psychiatric illness,
  • alcohol and substance use disorder,
  • cancer, neurological problems, congenital anomalies, musculoskeletal problems, systemic illness,
  • facial paralysis,
  • spinal, abdominal and/or TMJ surgery,
  • and having received any spinal or TMJ treatment in less than 6 months.

Treatment and study plan

Primary outcomes

  1. Oral Health Impact Profile-14 (OHIP-14)

    Time frame: February 2023- July 2023

    This scale, which has been shown to be valid and reliable in measuring oral and dental health-related quality of life, consists of 14 questions in 7 dimensions. Each question is scored from 0 (never) to 4 (always). The scale ranges from 0 to 56, with high scores indicating poor quality of life.

  2. Numerical Pain Scale (NPS)

    Time frame: February 2023- July 2023

    This simple, valid and reliable method, often used to measure pain intensity in the clinic, asks the participant to mark a number on a 10 cm scale with numbers ranging from '0' (no pain) to '10' (unbearable pain) for the pain felt in the TMJ region

  3. Fonseca Anamnestic Questionnaire (FAQ)

    Time frame: February 2023- July 2023

    This scale, which has been shown to be valid and reliable as a TMD assessment tool, consists of 10 questions. A score of 25 or more on the scale indicates the presence of TMD.

  4. Jaw Functional Limitation Scale-8 (JFLS-8)

    Time frame: February 2023- July 2023

    This scale, which has demonstrated validity and reliability, provides an assessment of chewing functionality during various activities of the jaw and consists of 8 questions. On this scale, which ranges from 0-80, a high score indicates limited chewing functionality.

  5. Eating Assessment Tool (EAT-10)

    Time frame: February 2023- July 2023

    This scale, which assesses the symptoms and severity of oropharyngeal swallowing disorder and has been shown to be valid and reliable, consists of 10 questions. A total score of 3 and above on the scale, indicates the presence of a swallowing problem.

Sponsors and collaborators

Lead sponsor

Bandırma Onyedi Eylül University

Other

Registry information

Official study title

Oral Health, Temporomandibular Dysfunction and Oropharyngeal Dysphagia in Bipolar Patients

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 13, 2023
Registry last updated
Sep 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.