NCT06034769

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
Last Updated

September 14, 2023

Status Verified

September 1, 2023

Enrollment Period

5 months

First QC Date

September 6, 2023

Last Update Submit

September 13, 2023

Conditions

Bipolar DisordersOral Health

Keywords

Bipolar disordersOral healthTemporomandibular disorders

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients with bipolar disorder in remission

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bipolar DisorderTemporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersCraniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof. Dr

Study Record Dates

First Submitted

September 6, 2023

First Posted

September 13, 2023

Study Start

February 1, 2023

Primary Completion

July 1, 2023

Study Completion

July 20, 2023

Last Updated

September 14, 2023

Record last verified: 2023-09

Locations

TU(1)