Clinical trial NCT05957601: The Relationship Between the Parameters Affecting the Functionality of the Pelvic Floor and the Temporomandibular Joint
Official title: The Relationship Between the Parameters Affecting the Functionality of the Pelvic Floor and the Temporomandibular Joint
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pelvic Floor Disorders
Temporomandibular Joint Disorders
Keywords: pelvic floor
temporomandibular disorders
Lead sponsor: Hacettepe University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
name: Istanbul Training and Research Hospital
First posted: 2023-07-24
Enrollment: 59
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All women with pelvic floor dysfunction or healthy who met the inclusion criteria were included in the study.

Brief summary: The aim of our study is to examine the relationship between the parameters affecting the pelvic floor and temporomandibular joint (TMJ) functionality and to emphasize the necessity of investigating combined and coordinated exercise approaches in the treatment of dysfunctions that may occur in both specific regions. Our study, which is planned as an epidemiological research, will include 59 women between the ages of 20-50, who applied to the Istanbul Research and Training Hospital, Gynecology and Obstetrics Polyclinic, and volunteered to participate in the study. Assessments include pelvic floor dysfunction, pelvic floor muscle activation, sacroiliac joint mobility, pelvis position, and pain for pelvic floor functionality; temporomandibular joint dysfunction, masseter muscle activation, temporomandibular joint range of motion, position of the mandible and pain for temporomandibular joint funstionlaity; strength of the muscles located on the deep anterior line and thought to be related, flexibility, myofascial trigger points and depression level for mediating factors affecting functionality. After the data are completed, the Kolmogorov-Smirnov test will be applied to determine whether the data fit the normal distribution before starting the statistical analysis. Pearson Correlation test will be applied between dependent variables, independent variables and mediating factors in case the data show normal distribution, and Spearman Correlation test will be applied if it does not show normal distribution.

Significance value will be determined as p\<0.05, correlation coefficient between variables r: 0-0.46 (weak); r: 0.5-0.74 (medium); r: will be interpreted as 0.75-1.0 (strong).

Detailed description: It is known that there are postural changes in individuals with temporomandibular joint dysfunction (TMD). Although studies on this subject have focused mostly on the head, neck and shoulder regions, recent studies have shown that in addition to the opposite direction of head deviation and rectification in the thoracic region in individuals with TMD; It also indicates the presence of hyperlordosis in the lumbar region and posterior rotation of the pelvis. Similarly, Garstka et al. reported that unilateral sacroiliac joint locking was observed in individuals with clicking problems in temporomandibular joint (TMJ). Studies indicate that these effects of TMJ extending to the pelvic girdle occur through the facial pathways and that similar increases in symptoms in these regions are associated with emotional stress. A local change in a muscle segment first lengthens and shortens the muscles in close distance, and then acts on the other muscles on the fascial chain, thanks to the fascial pathways. The deep anterior fascial line starts from the sole of the foot and continues from the back of the leg bones to the inner side of the knee and thigh.While its main pathways pass in front of the hip joint, pelvis and lumbar spine, it proceeds with an alternate branch to the pelvic floor and the first lumbar spine. From the psoas-diaphragm space, it continues along several alternative pathways, covering the entire thorax and viscera, ending in both the neuro- and viscerocranium. Although the relationship of the TMJ with other structures on the connecting pathways has been the subject of many studies by looking at the fascial pathways of the deep anterior fascial line no study has been found that comprehensively examined the parameters of the TMJ and the pelvic floor. However, pelvic floor dysfunctions, urinary incontinence, faecal incontinence, pelvic organ prolapse, chronic pelvic pain, etc. It affects the psychology, physical condition, social life, family life, professional and sexual life of millions of women around the world. This study was planned because the etiology of dysfunctions of both regions is similar, they are located on the same fascial line, and although positive correlation results were obtained for other regions on the same fascial line, there was no previous study examining the relationship between TMJ and pelvic floor. In our study, we aim to emphasize the necessity of investigating combined and coordinated approaches in the prevention and treatment of dysfunctions that may occur in both specific regions by determining the relationship between the functionality of the pelvic floor and the TMJ and the factors affecting the relationship in women.

Eligibility criteria: Inclusion Criteria:

* having applied to the Istanbul Research and Training Hospital, Gynecology and Obstetrics Polyclinic,
* being literate
* being between 20-50 years old
* volunteering to participate in the study

Exclusion Criteria:

* pregnancy
* menopause
* having the cooperation problem
* history of active cancer
* urinary infection found during evaluation
* being in the period of menstruation at the time of assessment
* having a neurological, orthopedic or serious metabolic disease that may affect pelvic floor functions.

Primary outcomes:
measure: Evaluation of pelvic floor dysfunction
timeFrame: Baseline
measure: Evaluation of temporomandibular joint dysfunction
timeFrame: Baseline
measure: Evaluation of pelvic floor muscle activation
timeFrame: Baseline
measure: Evaluation of masseter muscle activation
timeFrame: Baseline
measure: Evaluation of sacroiliac joint mobility
timeFrame: Baseline
measure: Evaluation of temporomandibular range of motion
timeFrame: Baseline
measure: Evaluation of pelvic pain
timeFrame: Baseline
measure: Evaluation of temporomandibular joint pain
timeFrame: Baseline
Secondary outcomes:
measure: Evaluation of the strength of the muscles that are thought to be related and located on the Deep Anterior Facial Line
timeFrame: Baseline
measure: Evaluation of flexibility
timeFrame: Baseline
measure: Evaluation of cervical range of motion
timeFrame: Baseline
measure: Evaluation of trigger points
timeFrame: Baseline
measure: Evaluation of depression
timeFrame: Baseline
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Research and Training Hospital
Study officials:
affiliation: Hacettepe University
name: Türkan Akbayrak, Prof. Dr.
role: STUDY_CHAIR
References:
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