- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06123351
Forward Head Posture Correction Impact on Temporomandibular Dysfunction
Forward Head Posture Correction Impact on Temporomandibular Dysfunction: A Randomized Controlled Trial
The goal of this clinical trial is to test the effect of nerd neck correction on damaged jaw in people who suffers from jaw problems and nerd neck. The main question it aims to answer:
- whether there are different effects of traditional nerd neck correction exercises, device correction method and dental splints on jaw features of pain and function.
Participants will:
- participants will be given the consent to sign first.
- participants will be assessed to check jaw pain and function.
- participants will be divided randomly into 3 groups.
- Each group will be given the treatment sessions for 6 weeks.
- participants will come back after 6 weeks for one last assessment.
Researchers will compare traditional, new and dental treatment groups to see if there is improvement in jaw characteristics.
Study Overview
Status
Conditions
Detailed Description
The relationship between the two conditions of forward head posture (FHP) and temporomandibular joint dysfunction (TMD) have been previously stated with comparing the craniocervical angle (CVA) of TMD patients to the healthy individuals, still a clear relationship couldn't be drawn due to different study limitations such as the lack of subdivision in the TMD patients based on their diagnostic subcategories in addition to, patients posture might have been altered while the photo was captured. Ever since, multiple researchers deliberately investigated the two conditions association and inferred the following: 1. FHP can be a risk factor resulting in TMD where any alteration in the head position produces more tension on the masticatory muscles by changing the mandible position 2. TMD origins from muscular component is more significant than articular component yet the correlation between head posture and TMD is still not clear enough, however, if FHP and myogenic TMD were linked preventive measures can be taken. recently, multiple studies established a relation between the occurrence of FHP in TMD patients which supported the hypothesized relation between them.
Till present, no study has investigated the FHP Denneroll cervical traction orthodontic (DCTO) correction impact alone on TMD and this is where the purpose of this study arises from.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Shima Mohammad Zadeh
- Phone Number: +971503077039
- Email: U22103961@sharjah.ac.ae
Study Contact Backup
- Name: Tamer Shousha
- Email: Tshousha@sharjah.ac.ae
Study Locations
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Sharjah, United Arab Emirates, 0000
- University of Sharjah
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Contact:
- Tamer Shousha
- Email: Tshousha@sharjah.ac.ae
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- The participant experiencing one or more of TMD signs or symptoms and has been diagnosed with TMD beside having forward head posture with craniocervical (CVA) angle < 50.
- The study will be limited to the patients in the dental clinic of the university of Sharjah.
- Participants experiencing mild to moderate myogenic TMD with symptoms of orofacial pain and limited range of jaw opening.
Exclusion Criteria:
- Previous head, neck or TMJ traumas.
- History of temporomandibular joint surgery.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Denneroll protocol
orthotic will be placed under participants' neck.
Treatment session time begin with 3 minutes then increase of 2-3 minutes until they reach 15 to 20 minutes in each session.
|
traction for 3 to 15 minutes once daily
|
|
Active Comparator: Traditional protocol
consists of one strengthening exercise for 10 repetitions in 3 sets each, and two stretching exercises with a hold for 20-30 seconds.
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strengthening exercises with 10 repetitions twice per day 3 times per week stretching exercises with hold for 20 to 30 seconds 3 repetitions daily
|
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Active Comparator: Dental management
formed soft occlusal splint will be individually designed for the upper arch of each participant.
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2 mm thick elastic rubber sheets
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anamnestic questionnaire by Fonseca
Time Frame: Baseline (pre-treatment) and week 7 (post-treatment)
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To evaluate TMD by 10 questions with their corresponding scores from 0 to 1
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Baseline (pre-treatment) and week 7 (post-treatment)
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Craniocervical angle - CVA
Time Frame: Baseline (pre-treatment) and week 7 (post-treatment)
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photographic method to evaluate the angle where an angle less than 50 degrees will be considered as forward head posture
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Baseline (pre-treatment) and week 7 (post-treatment)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Boley Gauge
Time Frame: Baseline (pre-treatment) and week 7 (post-treatment)
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Electronic Digital Caliper to assess mouth opening (active/passive)
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Baseline (pre-treatment) and week 7 (post-treatment)
|
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Numerical Rating Scale (NRS)
Time Frame: Baseline (pre-treatment) and week 7 (post-treatment)
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0-10 scale (zero represents no pain and 10 is the worst pain ever) to record orofacial pain
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Baseline (pre-treatment) and week 7 (post-treatment)
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Mandibular Opening
Time Frame: Baseline (pre-treatment) and week 7 (post-treatment)
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Tape to measure the distance between the incisal edges of upper and lower teeth
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Baseline (pre-treatment) and week 7 (post-treatment)
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Shima Mohammad zadeh, University of Sharjah
- Principal Investigator: Tamer Shousha, University of Sharjah
Publications and helpful links
General Publications
- Lee WY, Okeson JP, Lindroth J. The relationship between forward head posture and temporomandibular disorders. J Orofac Pain. 1995 Spring;9(2):161-7.
- Salkar RG, Radke UM, Deshmukh SP, Radke PM. Relationship between temporomandibular joint disorders and body posture. Int J Dent Health Sci. 2015;2(6):1523-30.
- Saddu SC, Dyasanoor S, Valappila NJ, Ravi BV. The Evaluation of Head and Craniocervical Posture among Patients with and without Temporomandibular Joint Disorders- A Comparative Study. J Clin Diagn Res. 2015 Aug;9(8):ZC55-8. doi: 10.7860/JCDR/2015/12830.6343. Epub 2015 Aug 1.
- El-Hamalawy FA. Forward head correction exercises for management of myogenic tempromandibular joint dysfunction. 2011;7(8)
- Tang Y, Xu LL, Fan S. [Control study of forward head posture between patients with temporomandibular disorders and healthy people]. Shanghai Kou Qiang Yi Xue. 2021 Apr;30(2):173-176. Chinese.
- Xiao CQ, Wan YD, Li YQ, Yan ZB, Cheng QY, Fan PD, Huang Y, Wang XY, Xiong X. Do Temporomandibular Disorder Patients with Joint Pain Exhibit Forward Head Posture? A Cephalometric Study. Pain Res Manag. 2023 Feb 2;2023:7363412. doi: 10.1155/2023/7363412. eCollection 2023.
- Minervini G, Franco R, Marrapodi MM, Crimi S, Badnjevic A, Cervino G, Bianchi A, Cicciu M. Correlation between Temporomandibular Disorders (TMD) and Posture Evaluated trough the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD): A Systematic Review with Meta-Analysis. J Clin Med. 2023 Apr 2;12(7):2652. doi: 10.3390/jcm12072652.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- Joint Diseases
- Musculoskeletal Diseases
- Muscular Diseases
- Stomatognathic Diseases
- Jaw Diseases
- Craniomandibular Disorders
- Mandibular Diseases
- Myofascial Pain Syndromes
- Temporomandibular Joint Disorders
- Temporomandibular Joint Dysfunction Syndrome
- Anti-Infective Agents
- Dermatologic Agents
- Antifungal Agents
- Keratolytic Agents
- Salicylic Acid
Other Study ID Numbers
- FHP-TMD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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