Temporomandibular; Functional DisturbanceNCT06946147
Assessment of Temporomandibular Joint Function Across Different Trimesters of Pregnancy
An observational study of Temporomandibular; Functional Disturbance, run by Cairo University at 1 site in Egypt.
Trial summary
This study will be conducted to assess Temporomandibular Joint (TMJ) function across different trimesters of pregnancy. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular; Functional Disturbance
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Apr 2025to 15 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Twenty pregnant women and twenty non-pregnant women will participate in this study.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This study will be conducted to assess Temporomandibular Joint (TMJ) function across different trimesters of pregnancy.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 5 months
Secondary outcomes (2)
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
Measured: 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.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start30 Apr 2025 (estimated)
- Primary completion28 Feb 2026 (estimated)
- Study completion15 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular; Functional DisturbanceStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Zaghloul Mohammed, Cairo University
- Investigators
- HAZEM EL ASHMAWY, Professor, Study director, Cairo UniversityDoaa Osman, Professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06946147
- Sponsor's protocol ID
- P.T.REC/012/005674
- Status last verified
- Apr 2025
- First submitted
- 19 Apr 2025
- Last updated
- 27 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Temporomandibular Joint Function Across Different Trimesters of Pregnancy
- ClinicalTrials.gov ID
- NCT06946147
- Acronym / sponsor ID
- P.T.REC/012/005674
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Apr 2025 (estimated)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 15 Mar 2026 (estimated)
- First posted
- 27 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Twenty pregnant women and twenty non-pregnant women will participate in this study.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Other | Non- pregnant women, Pregnant women |
Primary outcome
Mouth Opening (Eyes Open)
Time frame: 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)
Time frame: 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):
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
2 secondary outcomes
Assessment of severity of temporomandibular joint dysfunction
Time frame: 5 months
Assessment of temporomandibular joint pain
Time frame: 5 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
HAZEM EL ASHMAWY, Professor study director
Cairo University
Doaa Osman, Professor study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Temporomandibular; Functional Disturbance, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maha Z Mohammed, Master (+201127038899, mahayoussef356@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mouth Opening (Eyes Open) (time frame: 5 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.