Clincosm LogoSign in Get a demo

Oral and Jaw Health in Bipolar Patients

Sponsor
Bandırma Onyedi Eylül University (Other)
Overall Status
Completed
CT.gov ID
NCT06034769
Collaborator
(none)
70
Enrollment
1
Location
5.6
Actual Duration (Months)
12.6
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

    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).

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    70 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    Oral Health, Temporomandibular Dysfunction and Oropharyngeal Dysphagia in Bipolar Patients
    Actual Study Start Date :
    Feb 1, 2023
    Actual Primary Completion Date :
    Jul 1, 2023
    Actual Study Completion Date :
    Jul 20, 2023

    Outcome Measures

    Primary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bakırkoy Prof. Dr. Mazhar Osman Mental Health and Neurological Diseases Training and Research Hospital Istanbul Turkey

    Sponsors and Collaborators

    • Bandırma Onyedi Eylül University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hazel Çelik Güzel, Assist. Prof. Dr, Bandırma Onyedi Eylül University
    ClinicalTrials.gov Identifier:
    NCT06034769
    Other Study ID Numbers:
    • 2023-44
    First Posted:
    Sep 13, 2023
    Last Update Posted:
    Sep 14, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hazel Çelik Güzel, Assist. Prof. Dr, Bandırma Onyedi Eylül University
    Bipolar disorders
    Oral health
    Temporomandibular disorders
    Additional relevant MeSH terms:
    Bipolar Disorder

    Study Results

    No Results Posted as of Sep 14, 2023