- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04819087
Assessment Of The Effect Of Pelvic Floor Dysfunction Related Temporamandibular Joint Problems On Tinnitus
The pelvic floor serves as stability and support as it is the postural balance and core resource base for the pelvic organs. A dysfunction in the organs in this area can affect the pelvic floor muscles, the functioning of an organs in the muscles. Incontinence organ prolapse, pelvic pain and sexual problems may occur when the support or stability of the pelvic floor is impaired. Pelvic floor novelization is not always seen weakness. Sometimes excessive contractions and excessive activity in muscle tone can be seen. Stress and anxiety-related tension are the main causes of pelvic floor dysfunctions. Involuntary contractions and excessive muscle tone in the pelvic floor muscles cause chronic pelvic pain syndrome, constipation and dyssynergic defecation problems. Some of these patients have complaints of tightening teeth in the temporamandibular joint, grinding teeth at night, together with contractions in the pelvic floor.
The aim of this study is to investigate the effect of pelvic floor improvement on tinnitus level as a result of dysfunctional condition in temporamandibular joint with treatment practices of pelvic floor patients with excessive muscle activity.
Study Overview
Status
Intervention / Treatment
Detailed Description
The pelvic floor serves as stability and support as it is the postural balance and core resource base for the pelvic organs. A dysfunction in the organs in this area can affect the pelvic floor muscles, the functioning of an organs in the muscles. Incontinence organ prolapse, pelvic pain and sexual problems may occur when the support or stability of the pelvic floor is impaired. Pelvic floor novelization is not always seen weakness. Sometimes excessive contractions and excessive activity in muscle tone can be seen. Stress and anxiety-related tension are the main causes of pelvic floor dysfunctions. Involuntary contractions and excessive muscle tone in the pelvic floor muscles cause chronic pelvic pain syndrome, constipation and dyssynergic defecation problems. Some of these patients have complaints of tightening teeth in the temporamandibular joint, grinding teeth at night, together with contractions in the pelvic floor.
Diagnosis of patients in the temporamandibular joint is very difficult for the clinician. The difficulty of identifying etiological factors and the fact that dysfunction is associated with multifactorial factors make it mandatory to use different assessment methods in diagnosing patients with Temporamandibular joint dysfunction (TMD). One of the indexes used to diagnose TMD patients in a healthy population is the" Fonseca Anamnestic Index (FAI)". The low cost and easy applicability of the index make it preferred for TMD patients at the stage of diagnosis (Ayalı ve Ramoğlu, 2014; Türken vd., 2020).
In the pathogenesis of TMD, parafunctional habits such as day and night tooth tightening, tooth grinding, nail eating, lip biting, cheek biting, pen biting, chewing gum play an important role. It has been reported that there is often a positive correlation between TMD and parafunctional habits. "Oral Behavior Checklist (OBC)" is used in the diagnosis of such oral habits (Güngör, 2019; Türken vd., 2020).
It is thought that this dysfunctional condition in the temporamandibular joint may cause tinnitus in patients. The fact that tinnitus is subjective and an unsolved symptom related to the mechanisms of its occurrence makes it difficult to obtain objective assessment and concrete data. For this reason, the evaluation of tinnitus is again possible by perceptual measurement. For this purpose, psychoacoustic tests such as tinnitus intensity and frequency matching, maskability, residual inhibition, and verbal, numerical, and visual rating scales are used to evaluate tinnitus (Meikle vd., 2008). The Tinnitus Disability Questionnaire is the only scale with validity and reliability in Turkish and is widely used in our country to determine the level of tinnitus (Aksoy vd., 2007).
Although the use of scale is an important tool in determining the level of tinnitus, it is difficult for each person to express their condition as it is. It is known that some patients may exaggerate or underestimate their complaints, each scale has strengths and weaknesses, and sensitivity may vary depending on the therapy used. Since most of the scales are developed in English, it should be considered that when applied to different cultures and socio-economic groups, there may be changes in specificity and sensitivity (Langguth vd., 2006). For this reason, the addition of a structured interview form as a standard in addition to the scale strengthens the opinion of the clinician.
Accordingly, it is expected that temporamandibular joint loosens after treatment applications in patients with pelvic floor dysfunction. As a result of this relaxation, we believe that there may be a decrease in the level of tinnitus felt in patients.
The aim of this study is to investigate the effect of pelvic floor improvement on tinnitus level as a result of dysfunctional condition in temporamandibular joint with treatment practices of pelvic floor patients with excessive muscle activity.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nedim Uğur Kaya, Lecturer
- Phone Number: +90 5301571858
- Email: nedim.ugur.kaya@karatay.edu.tr
Study Contact Backup
- Name: Sare Nur Kayacık, Lecturer
- Phone Number: +90 542 738 39 45
- Email: sare.nur.karakol@karatay.edu.tr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients between 18-65 years
- Patients with Pelvic Plate Disorders
- Patients with Tinnitus Patients with Temporomandibular Joint Disorders
Exclusion Criteria:
- Patients under 18 years and over 65 years
- Patients without Pelvic Plate Disorders
- Patients without Tinnitus
- Patients without Temporomandibular Joint Disorders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patients
Patients with Pelvic Floor Dysfunction Related Temporamandibular Joint Problems and Tinnitus
|
Questionnaires and Rehabilitation Programs
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tinnitus Disability Questionnaire
Time Frame: Change from Baseline and 10 Weeks
|
The application of the questionnaire, which is not affected by hearing loss, age and gender, gives both easy and psychometric clearer measurements.
The questionnaire consisting of 25 questions examines the perception of tinnitus and psychosocial status of the patient
|
Change from Baseline and 10 Weeks
|
Fonseca Anamnestic Index
Time Frame: Change from Baseline and 10 Weeks
|
FAI is a questionnaire consisting of 10 questions that determine the presence of pain in TME, head, back areas and during chewing, parafunctional habits, movement restriction, clique, malocclusion, emotional stress
|
Change from Baseline and 10 Weeks
|
Oral Behavioral Survey Questions
Time Frame: Change from Baseline and 10 Weeks
|
In the pathogenesis of TMD, parafunctional habits such as day and night tooth tightening, tooth grinding, nail eating, lip biting, cheek biting, pen biting, chewing gum play an important role.
A positive association has often been reported between TMD and parafunctional habits.
"Oral Behavior Checklist (OBC)", a survey study consisting of 21 Questions, is used to diagnose such oral habits
|
Change from Baseline and 10 Weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Aksoy S, Firat Y, Alpar R. The Tinnitus Handicap Inventory: a study of validity and reliability. Int Tinnitus J. 2007;13(2):94-8.
- Ayalı, A., Ramoğlu, S. (2014). Kuzey kıbrıs'ta diş hekimliği fakültesi öğrencilerinde temporomandibuler eklem disfonksiyonu'nun prevalansı ve şiddetinin araştırılması, Atatürk Üniv. Diş Hek. Fak. Derg. Cilt:24, Sayı:3, Yıl: 2014, Sayfa: 367-372
- Langguth B, Goodey R, Azevedo A, Bjorne A, Cacace A, Crocetti A, Del Bo L, De Ridder D, Diges I, Elbert T, Flor H, Herraiz C, Ganz Sanchez T, Eichhammer P, Figueiredo R, Hajak G, Kleinjung T, Landgrebe M, Londero A, Lainez MJ, Mazzoli M, Meikle MB, Melcher J, Rauschecker JP, Sand PG, Struve M, Van de Heyning P, Van Dijk P, Vergara R. Consensus for tinnitus patient assessment and treatment outcome measurement: Tinnitus Research Initiative meeting, Regensburg, July 2006. Prog Brain Res. 2007;166:525-36. doi: 10.1016/S0079-6123(07)66050-6.
- Türken, R., Büyük, S. K., Yaşa, Y. (2020). Diş Hekimliği Fakültesi Öğrencilerinde Temporomandibular Eklem Rahatsızlıklarının ve Ağız Sağlığı Alışkanlıklarının Değerlendirilmesi, ACU Sağlık Bil Derg 2020; 11(2):208-213, https://doi.org/10.31067/0.2018.83
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Neurologic Manifestations
- Musculoskeletal Diseases
- Muscular Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Ear Diseases
- Pregnancy Complications
- Sensation Disorders
- Jaw Diseases
- Hearing Disorders
- Craniomandibular Disorders
- Mandibular Diseases
- Myofascial Pain Syndromes
- Disease
- Joint Diseases
- Temporomandibular Joint Disorders
- Temporomandibular Joint Dysfunction Syndrome
- Pelvic Floor Disorders
- Tinnitus
Other Study ID Numbers
- KTOODY001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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