Assessment of Temporomandibular Joint Function Across Different Trimesters of Pregnancy

NCT06946147 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/005674
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be conducted to assess Temporomandibular Joint (TMJ) function across different trimesters of pregnancy.

Conditions

Temporomandibular; Functional Disturbance

Outcome Measures

Primary Outcomes (8)

• Mouth Opening (Eyes Open)

  The woman opens her mouth maximally. The vertical distance between the upper and lower central incisors is measured using a caliper. One-third of the full temporomandibular joint range of motion (ROM) is used as functional ROM. The caliper is adjusted to this range. The woman practices the motion three times, then performs it actively three times with eyes open. Mean absolute joint position error (JPE) is recorded.

  5 months

• Mouth Opening (Eyes Closed)

  The woman opens her mouth maximally. The vertical distance between the upper and lower central incisors is measured using a caliper. One-third of the full temporomandibular joint range of motion (ROM) is used as functional ROM. The caliper is adjusted to this range. The woman practices the motion three times, then performs it actively three times with eyes closed. Mean absolute joint position error (JPE) is recorded.

  5 months

• Right Lateral Movement (Eyes Open):

  From rest, the woman moves her jaw to the right. The horizontal distance between upper and lower incisors is measured. Functional range of motion ROM is calculated (one-third of full ROM). She practices then actively performs the movement three times. Joint position error (JPE) is recorded.

  5 months

• Right Lateral Movement (Eyes Closed)

  From rest, the woman moves her jaw to the right. The horizontal distance between upper and lower incisors is measured. Functional range of motion (ROM) is calculated (one-third of full ROM). She practices then actively performs the movement three times but with eyes closed. Joint position error (JPE) is recorded.

  5 months

• Left Lateral Movement (Eyes Open)

  From rest, the woman moves her jaw to the left. The horizontal distance between upper and lower incisors is measured. Functional range of motion (ROM) is calculated (one-third of full ROM). She practices then actively performs the movement three times.Joint position error (JPE) is recorded.

  5 months

• Left Lateral Movement (Eyes Closed)

  rom rest, the woman moves her jaw to the left. The horizontal distance between upper and lower incisors is measured. Functional range of motion (ROM) is calculated (one-third of full ROM). She practices then actively performs the movement three times but with eye closed. Error of JPE is recorded.

  5 months

• Jaw protrusion (Eyes Open)

  From rest, the woman moves her jaw forward. Distance between upper and lower incisors is measured. Functional range of motion (ROM) is calculated. Movement is practiced and repeated three times. Joint position error (JPE) is recorded.

  5 months

• Jaw protrusion (Eyes Closed)

  From rest, the woman moves her jaw forward. Distance between upper and lower incisors is measured. Functional range of motion (ROM) is calculated. Movement is practiced and repeated three times but with closed eyes. Joint position error (JPE) is recorded.

  5 months

Secondary Outcomes (2)

• Assessment of severity of temporomandibular joint dysfunction

  5 months

• Assessment of temporomandibular joint pain

  5 months

Study Arms (2)

Pregnant women

Assessment of Temporomandibular Joint Function will be conducted in pregnant women through different trimesters of pregnancy at specific measuring times: Baseline: early first trimester (before 12 weeks of gestation). Second trimester: between 18 and 21 weeks of gestation. Third trimester: between 31 and 34 weeks of gestation.

Non- pregnant women

Assessment of Temporomandibular Joint Function will be conducted in non-pregnant healthy women.

Eligibility Criteria

• Age: 20 Years - 35 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Twenty pregnant women and twenty non-pregnant women will participate in this study.

You may qualify if:

• All women will be pregnant with a single baby. Their ages will range from 20 to 35 years old. Their parity will range from 1 to 2. Their body mass index will range from 20 to 30kg2.

You may not qualify if:

• All women will not suffer from any TMJ disorder or orofacial pain before pregnancy.
• All women will not suffer from any severe dental pathology. All women will not suffer from high-risk pregnancy (hyperemesis gravidarum, gestational diabetes).
• All women will not suffer from any systemic illnesses.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Maha Zaghloul mohammed

Cairo, Egypt

Location

Study Officials

• HAZEM EL ASHMAWY, Professor

  Cairo University

  STUDY DIRECTOR

• Doaa Osman, Professor

  Cairo University

  STUDY CHAIR

Central Study Contacts

Maha Z Mohammed, Master

CONTACT

+201127038899; mahayoussef356@gmail.com

Amira N Abdellatif, PHD

CONTACT

+201021177871; Amira.nagy@rochetmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 19, 2025
• First Posted: April 27, 2025
• Study Start: April 30, 2025
• Primary Completion: February 28, 2026
• Study Completion: March 15, 2026
• Last Updated: April 27, 2025

Record last verified: 2025-04

Locations

EG (1)