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Oral and Jaw Health in Bipolar Patients

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ClinicalTrials.gov Identifier: NCT06034769
Recruitment Status : Completed
First Posted : September 13, 2023
Last Update Posted : September 14, 2023
Sponsor:
Information provided by (Responsible Party):
Hazel Çelik Güzel, Bandırma Onyedi Eylül University

Study Description
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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
Bipolar Disorders Oral Health

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
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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 : February 1, 2023
Actual Primary Completion Date : July 1, 2023
Actual Study Completion Date : July 20, 2023

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with bipolar disorder in remission
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.
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06034769


Locations
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Turkey
Bakırkoy Prof. Dr. Mazhar Osman Mental Health and Neurological Diseases Training and Research Hospital
Istanbul, Turkey
Sponsors and Collaborators
Bandırma Onyedi Eylül University
More Information
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Responsible Party: Hazel Çelik Güzel, Assist. Prof. Dr, Bandırma Onyedi Eylül University
ClinicalTrials.gov Identifier: NCT06034769    
Other Study ID Numbers: 2023-44
First Posted: September 13, 2023    Key Record Dates
Last Update Posted: September 14, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hazel Çelik Güzel, Bandırma Onyedi Eylül University:
Bipolar disorders
Oral health
Temporomandibular disorders
Additional relevant MeSH terms:
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Bipolar Disorder
Bipolar and Related Disorders
Mood Disorders
Mental Disorders