Temporomandibular Joint Function, Oral Habits and Pain Complaints of Pregnant Women

NCT06760884 | Recruiting

• 1 other identifier: KTU-FTR-2024/123
• Study Type: observational
• Target: 224
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to examine the temporomandibular joint functions, oral habits and pain complaints of pregnant women. .

Conditions

Temporomandibular Disorders (TMD); Pregnancy

Keywords

temporomandibular disorders; pregnancy; oral habits; pain

Outcome Measures

Primary Outcomes (2)

• Temporomandibular disorders function

  Fonseca Anamnestic Index, which is reported as a reliable and valid index, will be used to evaluate the presence/absence of temporomandibular disorder and the severity of the disorder.

  1 year

• Mandibular function

  The Mandibular Function Impairment Questionnaire (MFBA), a questionnaire that evaluates jaw function impairment with different sub-dimensions, will also be used.

  1 year

Secondary Outcomes (2)

• Oral Habits

  1 year

• Pain assessment

  1 year

Study Arms (2)

Study group

Pregnancy women

Control group

Non-Pregnancy women

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Only females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The universe of the study consists of women who apply to the pregnancy clinic. In parallel, a control group of 112 healthy non-pregnant women (similar to the pregnant group in terms of age, height, weight, education level, etc. to ensure homogeneity) will be created.

You may qualify if:

• Being between the ages of 18-45,
• At least primary school graduate,
• Able to speak and understand Turkish,
• Women diagnosed with pregnancy by USG,
• Singleton pregnancy,
• Agreeing to participate in the study voluntarily.

You may not qualify if:

• Those with any systemic disease concerning the musculoskeletal system,
• Women with any type of disability,
• Having communication problems,
• Multiple pregnancy,
• Refusing to participate in the study.
• Being between the ages of 18-45,
• At least primary school graduate,
• Able to speak and understand Turkish,
• Agreeing to participate in the study voluntarily.
• Those with any systemic disease concerning the musculoskeletal system,
• Women with any type of disability,
• Having communication problems,
• Refusing to participate in the study.

Sponsors & Collaborators

• Karadeniz Technical University: lead

Study Sites (1)

Karadeniz Technical Univerity

Trabzon, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Pain

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Nurhayat Korkmaz, MSc

CONTACT

+905387369062; krkmznrhyt@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: January 7, 2025
• Study Start: December 2, 2024
• Primary Completion: April 30, 2025
• Study Completion: June 30, 2025
• Last Updated: January 7, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)