Clinical trial NCT06034769: Oral and Jaw Health in Bipolar Patients
Official title: Oral Health, Temporomandibular Dysfunction and Oropharyngeal Dysphagia in Bipolar Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bipolar Disorders
Oral Health
Keywords: Bipolar disorders
Oral health
Temporomandibular disorders
Lead sponsor: Bandırma Onyedi Eylül University
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with bipolar disorder in remission

Brief summary: 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).

Detailed description: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Oral Health Impact Profile-14 (OHIP-14)
timeFrame: February 2023- July 2023
measure: Numerical Pain Scale (NPS)
timeFrame: February 2023- July 2023
measure: Fonseca Anamnestic Questionnaire (FAQ)
timeFrame: February 2023- July 2023
measure: Jaw Functional Limitation Scale-8 (JFLS-8)
timeFrame: February 2023- July 2023
measure: Eating Assessment Tool (EAT-10)
timeFrame: February 2023- July 2023
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bakırkoy Prof. Dr. Mazhar Osman Mental Health and Neurological Diseases Training and Research Hospital
Study officials:
References: