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Assessment Of The Effect Of Pelvic Floor Dysfunction Related Temporamandibular Joint Problems On Tinnitus

Primary Purpose

Tinnitus, Temporomandibular Joint Disorders, Pelvic Floor Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Questionnaires and Rehabilitation Programs
Sponsored by
KTO Karatay University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus focused on measuring Tinnitus, Temporomandibular Joint Disorders, Pelvic Floor Disorders

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Patients

    Arm Description

    Patients with Pelvic Floor Dysfunction Related Temporamandibular Joint Problems and Tinnitus

    Outcomes

    Primary Outcome Measures

    Tinnitus Disability Questionnaire
    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
    Fonseca Anamnestic Index
    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
    Oral Behavioral Survey Questions
    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

    Secondary Outcome Measures

    Full Information

    First Posted
    March 11, 2021
    Last Updated
    March 25, 2021
    Sponsor
    KTO Karatay University
    Collaborators
    MEDICANA HOSPITAL, ANKARA
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04819087
    Brief Title
    Assessment Of The Effect Of Pelvic Floor Dysfunction Related Temporamandibular Joint Problems On Tinnitus
    Official Title
    Assessment Of The Effect Of Pelvic Floor Dysfunction Related Temporamandibular Joint Problems On Tinnitus
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2021 (Anticipated)
    Primary Completion Date
    September 2021 (Anticipated)
    Study Completion Date
    November 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    KTO Karatay University
    Collaborators
    MEDICANA HOSPITAL, ANKARA

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tinnitus, Temporomandibular Joint Disorders, Pelvic Floor Disorders
    Keywords
    Tinnitus, Temporomandibular Joint Disorders, Pelvic Floor Disorders

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    It is planned to include patients diagnosed with pelvic floor dysfunction between the ages of 18-65 in the study.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Patients
    Arm Type
    Experimental
    Arm Description
    Patients with Pelvic Floor Dysfunction Related Temporamandibular Joint Problems and Tinnitus
    Intervention Type
    Behavioral
    Intervention Name(s)
    Questionnaires and Rehabilitation Programs
    Other Intervention Name(s)
    Tinnitus Disability Questionnaire, Fonseca Questionnaire, Oral Habits Questionnaire, pelvic floor muscle rehabilitation with biofeedback, diaphragm breathing training, Electrical stimulation
    Intervention Description
    Questionnaires and Rehabilitation Programs
    Primary Outcome Measure Information:
    Title
    Tinnitus Disability Questionnaire
    Description
    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
    Time Frame
    Change from Baseline and 10 Weeks
    Title
    Fonseca Anamnestic Index
    Description
    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
    Time Frame
    Change from Baseline and 10 Weeks
    Title
    Oral Behavioral Survey Questions
    Description
    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
    Time Frame
    Change from Baseline and 10 Weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nedim Uğur Kaya, Lecturer
    Phone
    +90 5301571858
    Email
    nedim.ugur.kaya@karatay.edu.tr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sare Nur Kayacık, Lecturer
    Phone
    +90 542 738 39 45
    Email
    sare.nur.karakol@karatay.edu.tr

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    18229787
    Citation
    Aksoy S, Firat Y, Alpar R. The Tinnitus Handicap Inventory: a study of validity and reliability. Int Tinnitus J. 2007;13(2):94-8.
    Results Reference
    background
    Citation
    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
    Results Reference
    background
    PubMed Identifier
    17956816
    Citation
    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.
    Results Reference
    background
    Citation
    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
    Results Reference
    background

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