Assessment of Temporomandibular Joint Function Across Different Trimesters of Pregnancy

Not yet recruiting

• Conditions: Temporomandibular; Functional Disturbance

• Registration Number: NCT06946147
• Lead Sponsor: Cairo University

Brief Summary

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

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 Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-19
• Study First Submitted QC: 2025-04-19
• Last Update Submitted: 2025-04-19
• Study First Posted: 2025-04-27
• Last Update Posted: 2025-04-27
• Study Start: 2025-04-30
• Primary Completion: 2026-02-28
• Study Completion: 2026-03-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mouth Opening (Eyes Open)	5 months	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.
Mouth Opening (Eyes Closed)	5 months	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.
Right Lateral Movement (Eyes Open):	5 months	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.
Right Lateral Movement (Eyes Closed)	5 months	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.
Left Lateral Movement (Eyes Open)	5 months	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.
Left Lateral Movement (Eyes Closed)	5 months	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.
Jaw protrusion (Eyes Open)	5 months	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.
Jaw protrusion (Eyes Closed)	5 months	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.

Secondary Outcome Measures

Name	Time	Method
Assessment of severity of temporomandibular joint dysfunction	5 months	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
Assessment of temporomandibular joint pain	5 months	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.

Trial Locations

Locations (1)

Maha Zaghloul mohammed; 🇪🇬 Cairo, Egypt