Oral and Jaw Health in Bipolar Patients

Oral Health Clinical Trial

Official title:

Oral Health, Temporomandibular Dysfunction and Oropharyngeal Dysphagia in Bipolar Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06034769
• Other study ID #: 2023-44
• Status: Completed
• Start date: February 1, 2023
• Est. completion date: July 20, 2023

Study information

• Verified date: September 2023
• Source: Bandirma Onyedi Eylül University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 20, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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 Bakirkoy 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.

Related Conditions & MeSH terms

• Bipolar Disorder
• Bipolar Disorders
• Oral Health

Locations

Country	Name	City	State
Turkey	Bakirkoy Prof. Dr. Mazhar Osman Mental Health and Neurological Diseases Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bandirma Onyedi Eylül University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral Health Impact Profile-14 (OHIP-14)	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.	February 2023- July 2023
Primary	Numerical Pain Scale (NPS)	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	February 2023- July 2023
Primary	Fonseca Anamnestic Questionnaire (FAQ)	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.	February 2023- July 2023
Primary	Jaw Functional Limitation Scale-8 (JFLS-8)	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.	February 2023- July 2023
Primary	Eating Assessment Tool (EAT-10)	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.	February 2023- July 2023