Assessment of Temporomandibular Joint Function Across Different Trimesters of Pregnancy

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

Study Overview

• Status: Not yet recruiting
• Conditions: Temporomandibular; Functional Disturbance
• Intervention / Treatment: Other

Detailed Description

Pregnancy is a physiological state that can potentially influence the function and biomechanics of the Temporomandibular Joint (TMJ) due to hormonal changes, weight gain, and other associated factors. TMJ disorders are a common problem affecting a significant proportion of the population, with potential impacts on chewing, speaking, and other daily functions, significantly affecting a pregnant woman's quality of life.

Limited research has been conducted to comprehensively evaluate the changes in TMJ function and proprioception (repositioning accuracy) across different trimesters of pregnancy. By identifying and understanding the specific impacts of different trimesters of pregnancy on TMJ function, this study aims to provide insights that can help in the early detection and effective management of TMJ disorders. This, in turn, can improve the overall well-being and comfort of pregnant women, contributing to a more positive pregnancy experience.

Moreover, physiotherapists currently have limited guidelines specifically tailored for managing TMJ dysfunction in pregnant patients. This study aims to fill this gap by providing evidence-based insights into the mechanisms and risk factors associated with TMJ dysfunction during pregnancy. The findings can inform the development of clinical guidelines and therapeutic protocols that address the unique needs of pregnant women, ensuring safer and more effective care.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Maha Z Mohammed, Master; Phone Number: +201127038899; Email: mahayoussef356@gmail.com
• Study Contact Backup: Name: Amira N Abdellatif, PHD; Phone Number: +201021177871; Email: Amira.nagy@rochetmail.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Maha Zaghloul mohammed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of severity of temporomandibular joint dysfunction	The Fonseca's questionnaire follows the characteristics of a multidimensional evaluation. It is composed of 10 questions, which include checking for the presence of pain in the TMJ, head, back, and while chewing, parafunctional habits, movement limitations, joint clicking, perception of malocclusion, and sensation of emotional stress. The volunteers will be informed that the 10 questions should be answered with "yes," "no," and "sometimes," and that only one answer should be marked for each question. Each answer choice is assigned a score (typically 10 for "yes," 5 for "sometimes," and 0 for "no"). The total score is then calculated by summing the scores for all questions. Higher scores indicate a greater likelihood of TMJ dysfunction	5 months
Assessment of temporomandibular joint pain	The level of pain in the temporomandibular joint will be assessed through the visual analogue scale (VAS). The VAS is a pain rating scale, whose scores are based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and "worst pain" on the right end of the scale (10 cm). Measurements from the starting point (left end) of the scale to the participants' marks will be recorded in centimeters and will be interpreted as their pain level.	5 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Doaa Osman, Professor, Cairo University; Study Director: HAZEM EL ASHMAWY, Professor, Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2025
• Primary Completion (Estimated): February 28, 2026
• Study Completion (Estimated): March 15, 2026

Study Registration Dates

• First Submitted: April 19, 2025
• First Submitted That Met QC Criteria: April 19, 2025
• First Posted (Actual): April 27, 2025

Study Record Updates

• Last Update Posted (Actual): April 27, 2025
• Last Update Submitted That Met QC Criteria: April 19, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: P.T.REC/012/005674

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No