- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06156345
Additional Effect of Forward Head Posture Correction on Temporomandibular Dysfunction
Additional Effect of Forward Head Posture Correction on Temporomandibular Dysfunction: A Randomized Controlled Trial.
The goal of this clinical trial is to test the additional correction effect of nerd neck on damaged jaw in people who suffers from jaw problems and nerd neck at the same time. The main question it aims to answer:
• whether the additional correction of nerd neck impact the 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 2 groups.
- Each group will be given the treatment sessions for 6 weeks.
- participants will come back after 6 weeks for another last assessment. Researchers will compare regular treatment for Jaw with new device, regular only and dental treatment groups to see if there is improvement in jaw characteristics.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tamer Shousha
- Email: Tshousha@sharjah.ac.ae
Study Contact Backup
- Name: Shima AH Mohammadzadeh
- Phone Number: +971503077039
- Email: U22103961@sharjah.ac.ae
Study Locations
-
-
-
Sharjah, United Arab Emirates, 27272
- Recruiting
- University of Sharjah
-
Contact:
- Tamer Shousha
- Email: Tshousha@sharjah.ac.ae
-
Contact:
- Shima A Mohammad Zadeh
- Phone Number: 00971503077039
- Email: U22103961@sharjah.ac.ae
-
Principal Investigator:
- Shima A Mohammad Zadeh
-
Sharjah, United Arab Emirates, 0000
- Recruiting
- University of Sharjah
-
Contact:
- Tamer Shousha
- Email: Tshousha@sharjah.ac.ae
-
-
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Conservative with Denneroll
Participants will be supine lining with the 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 with the conservative management for TMD. |
Denneroll cervical traction orthodontic traction for 3 to 15 minutes once daily with conservative management of stretching and relaxation.
|
|
Active Comparator: Conservative
consists of teaching the patient the relaxed jaw position and stretching exercises for masseter and pterygoid muscles with hold of 20-30 seconds and 3-5 repetitions.
In addition to placebo traction.
|
conservative management of stretching and relaxation with placebo traction.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anamnestic questionnaire by Fonseca
Time Frame: Baseline (pre-treatment), 3rd and week 7 (post-treatment)
|
To evaluate TMD by 10 questions with their corresponding scores from 0 to 10
|
Baseline (pre-treatment), 3rd and week 7 (post-treatment)
|
|
Craniocervical angle - CVA
Time Frame: Baseline (pre-treatment), 3rd and week 7 (post-treatment)
|
photographic method to evaluate the angle where an angle less than 50 degrees will be considered as forward head posture
|
Baseline (pre-treatment), 3rd and week 7 (post-treatment)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Boley Gauge
Time Frame: Baseline (pre-treatment), 3rd and week 7 (post-treatment)
|
Electronic Digital Caliper to assess mouth opening (active/passive)
|
Baseline (pre-treatment), 3rd and week 7 (post-treatment)
|
|
Visual Analog Scale (VAS)
Time Frame: Baseline (pre-treatment), 3rd and week 7 (post-treatment)
|
0-10 scale (zero represents no pain and 10 is the worst pain ever) to record orofacial pain
|
Baseline (pre-treatment), 3rd and week 7 (post-treatment)
|
|
Mandibular Opening
Time Frame: Baseline (pre-treatment), 3rd and week 7 (post-treatment)
|
Tape to measure the distance between the incisal edges of upper and lower teeth
|
Baseline (pre-treatment), 3rd and week 7 (post-treatment)
|
Collaborators and Investigators
Sponsor
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 (Actual)
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
Other Study ID Numbers
- Added FHP correction on 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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