Temporomandibular DisorderNCT06156345
Additional Effect of Forward Head Posture Correction on Temporomandibular Dysfunction
A study testing Conservative with Denneroll and Conservative in people with Temporomandibular Disorder and Forward Head Posture, run by Shima Abdollah Mohammad Zadeh at 2 sites in United Arab Emirates.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Temporomandibular Disorder, Forward Head Posture
- What is being tested?
- Conservative with Denneroll and Conservative
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesUnited Arab Emirates
- Study dates
- 1 Mar 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Previous head, neck or TMJ traumas.
- History of temporomandibular joint surgery.
Trial locations and contacts
2 sites in 1 country.
Tamer Shousha contact
United Arab Emirates2 sites, 2 recruiting
- Recruiting
University of Sharjah
Sharjah city, 0000
Tamer Shousha, tshousha@sharjah.ac.ae
- Recruiting
University of Sharjah
Sharjah city, 27272
Shima A Mohammad Zadeh, 00971503077039, U22103961@sharjah.ac.ae
Tamer Shousha, Tshousha@sharjah.ac.ae
About this study
Official title: 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.
Read more
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.
Read the 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 suspected relation between them but without a clear association. Till present, no study has investigated the additional effect of FHP DCTO correction impact on myogenic TMD, and this is where the purpose of this study arises from.
- Conditions
- Temporomandibular Disorder, Forward Head Posture
- Being tested
- Conservative with Denneroll, Conservative
- Keywords
- Temporomandibular dysfunction, Pain, Traction, conservative treatment
- Medical subject headings
- Temporomandibular Joint Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conservative with DennerollDevice
Denneroll cervical traction orthodontic traction for 3 to 15 minutes once daily with conservative management of stretching and relaxation.
ConservativeOther
conservative management of stretching and relaxation with placebo traction.
| Study group | Role | What they receive |
|---|---|---|
| Conservative | Active comparator | 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. Receives: Other: Conservative |
| Conservative with Denneroll | Experimental | 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. Receives: Device: Conservative with Denneroll |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anamnestic questionnaire by Fonseca
To evaluate TMD by 10 questions with their corresponding scores from 0 to 10
Measured: Baseline (pre-treatment), 3rd and week 7 (post-treatment)
Craniocervical angle - CVA
photographic method to evaluate the angle where an angle less than 50 degrees will be considered as forward head posture
Measured: Baseline (pre-treatment), 3rd and week 7 (post-treatment)
Secondary outcomes (3)
Boley Gauge
Electronic Digital Caliper to assess mouth opening (active/passive)
Measured: Baseline (pre-treatment), 3rd and week 7 (post-treatment)
Visual Analog Scale (VAS)
0-10 scale (zero represents no pain and 10 is the worst pain ever) to record orofacial pain
Measured: Baseline (pre-treatment), 3rd and week 7 (post-treatment)
Mandibular Opening
Tape to measure the distance between the incisal edges of upper and lower teeth
Measured: Baseline (pre-treatment), 3rd and week 7 (post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start1 Mar 2024
- Primary completionFeb 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Permuted block randomization to ensure an equal number of allocations in each of the three groups (Conservative only and conservative with Denneroll cervical traction orthodontic). Each random block was stored in opaque sealed envelopes consecutively numbered with a third researcher. Once each participant officially joins the study the researcher will open the subsequent envelop.
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shima Abdollah Mohammad Zadeh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shima Abdollah Mohammad Zadeh, University of Sharjah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06156345
- Sponsor's protocol ID
- Added FHP correction on TMD
- Status last verified
- May 2024
- First submitted
- 24 Nov 2023
- Last updated
- 23 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to make individual participant data (IPD) available to other researchers.
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.
PubMed 7488986Salkar 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.
PubMed 26436048El-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.
PubMed 34109357Xiao 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.
PubMed 36776487Minervini 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.
PubMed 37048735Zadeh SAM, Shousha T, Moustafa IM, Khowailed I, Harrison DE. Does forward head posture correction improve temporomandibular joint dysfunction? A pilot randomized trial using a cervical extension traction orthotic. J Osteopath Med. 2025 Sep 8;126(5):221-231. doi: 10.1515/jom-2025-0081. eCollection 2026 May 1.
PubMed 40960141
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additional Effect of Forward Head Posture Correction on Temporomandibular Dysfunction: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06156345
- Acronym / sponsor ID
- Added FHP correction on TMD
- Conditions
- Temporomandibular Disorder, Forward Head Posture
- Keywords
- Temporomandibular dysfunction, Pain, Traction, conservative treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Shima Abdollah Mohammad ZadehUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 5 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 suspected relation between them but without a clear association. Till present, no study has investigated the additional effect of FHP DCTO correction impact on myogenic TMD, and this is where the purpose of this study arises from.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Permuted block randomization to ensure an equal number of allocations in each of the three groups (Conservative only and conservative with Denneroll cervical traction orthodontic). Each random block was stored in opaque sealed envelopes consecutively numbered with a third researcher. Once each participant officially joins the study the researcher will open the subsequent envelop.
| Arm | Type | Receives |
|---|---|---|
| Conservative | Active comparator | Other: Conservativeconsists 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 with Denneroll | Experimental | Device: Conservative with DennerollParticipants 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Previous head, neck or TMJ traumas.
- History of temporomandibular joint surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conservative with DennerollDenneroll cervical traction orthodontic traction for 3 to 15 minutes once daily with conservative management of stretching and relaxation. | Device | Conservative with Denneroll |
| Conservativeconservative management of stretching and relaxation with placebo traction. | Other | Conservative |
Primary outcome
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
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
3 secondary outcomes
Boley Gauge
Time frame: Baseline (pre-treatment), 3rd and week 7 (post-treatment)
Visual Analog Scale (VAS)
Time frame: Baseline (pre-treatment), 3rd and week 7 (post-treatment)
Mandibular Opening
Time frame: Baseline (pre-treatment), 3rd and week 7 (post-treatment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
- Background: PubMed 7488986Lee WY, Okeson JP, Lindroth J. The relationship between forward head posture and temporomandibular disorders. J Orofac Pain. 1995 Spring;9(2):161-7.
- BackgroundSalkar 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.
- Background: PubMed 26436048Saddu 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.
- BackgroundEl-Hamalawy FA. Forward head correction exercises for management of myogenic tempromandibular joint dysfunction. 2011;7(8)
- Background: PubMed 34109357Tang 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.
- Background: PubMed 36776487Xiao 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.
- Background: PubMed 37048735Minervini 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.
- Derived from this study: PubMed 40960141Zadeh SAM, Shousha T, Moustafa IM, Khowailed I, Harrison DE. Does forward head posture correction improve temporomandibular joint dysfunction? A pilot randomized trial using a cervical extension traction orthotic. J Osteopath Med. 2025 Sep 8;126(5):221-231. doi: 10.1515/jom-2025-0081. eCollection 2026 May 1.
- Individual participant dataSharing planned: No. No plan to make individual participant data (IPD) available to other researchers.
Related trials for Temporomandibular Disorder
Recruiting
R01_Pilot Jaw Muscle Phenotypes
Chronic TMD Pain, Temporomandibular Disorder
Recruiting
Evaluation of the Effect of Adding Sodium Bicarbonate to Lidocaine in the Treatment of Myofascial Pain Syndrome
Myofacial Pain, Myofacial Pain Syndrome
Recruiting
Clinical and Electromyographic Assessment of Occlusal Splint Therapy
Temporomandibular Joint Disorders
Recruiting
An Open Label Study Assessing REN Treatment in Headache Management in Temporomandibular Disorders
Temporomandibular Disorder, Orofacial Pain
Enrolling by invitationObservational study
Long-term Safety and Performance of Materialise's Patient-specific TMJ System.
Temporomandibular Joint Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tamer Shousha contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conservative with Denneroll and Conservative in people with Temporomandibular Disorder and Forward Head Posture, run by Shima Abdollah Mohammad Zadeh at 2 sites in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shima AH Mohammadzadeh (+971503077039, U22103961@sharjah.ac.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anamnestic questionnaire by Fonseca (time frame: Baseline (pre-treatment), 3rd and week 7 (post-treatment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06156345, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2024.