Temporomandibular DisorderNCT06123351
Forward Head Posture Correction Impact on Temporomandibular Dysfunction
A study testing Denneroll cervical traction orthodontic, stretching and strengthening exercises and Vacuum-formed soft occlusal splint in people with Temporomandibular Disorder and Forward Head Posture, run by Shima Abdollah Mohammad Zadeh at 1 site in United Arab Emirates.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Temporomandibular Disorder, Forward Head Posture
- What is being tested?
- Denneroll cervical traction orthodontic, stretching and strengthening exercises and Vacuum-formed soft occlusal splint
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- Oct 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 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
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tamer Shousha contact
United Arab Emirates1 site
University of Sharjah
Sharjah city, 0000
Tamer Shousha, tshousha@sharjah.ac.ae
About this study
Official title: 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.
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 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.
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 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.
- Conditions
- Temporomandibular Disorder, Forward Head Posture
- Being tested
- Denneroll cervical traction orthodontic, stretching and strengthening exercises, Vacuum-formed soft occlusal splint
- Keywords
- Traction, Exercise, Pain, Temporomandibular dysfunction
- Medical subject headings
- Temporomandibular Joint Disorders, Motor Activity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Denneroll cervical traction orthodonticDevice
traction for 3 to 15 minutes once daily
stretching and strengthening exercisesOther
strengthening exercises with 10 repetitions twice per day 3 times per week stretching exercises with hold for 20 to 30 seconds 3 repetitions daily
Vacuum-formed soft occlusal splintDevice
2 mm thick elastic rubber sheets
| Study group | Role | What they receive |
|---|---|---|
| Denneroll protocol | Experimental | 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. Receives: Device: Denneroll cervical traction orthodontic |
| Traditional protocol | Active comparator | consists of one strengthening exercise for 10 repetitions in 3 sets each, and two stretching exercises with a hold for 20-30 seconds. Receives: Other: stretching and strengthening exercises |
| Dental management | Active comparator | formed soft occlusal splint will be individually designed for the upper arch of each participant. Receives: Device: Vacuum-formed soft occlusal splint |
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 1
Measured: Baseline (pre-treatment) 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) and week 7 (post-treatment)
Secondary outcomes (3)
Boley Gauge
Electronic Digital Caliper to assess mouth opening (active/passive)
Measured: Baseline (pre-treatment) and week 7 (post-treatment)
Numerical Rating Scale (NRS)
0-10 scale (zero represents no pain and 10 is the worst pain ever) to record orofacial pain
Measured: Baseline (pre-treatment) 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) 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 posted8 Nov 2023
- Study startOct 2025 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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 (traditional, Denneroll cervical traction orthodontic and dental treatment). 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 63 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
- Investigators
- Shima Mohammad zadeh, Study director, University of SharjahTamer Shousha, Principal investigator, University of Sharjah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06123351
- Sponsor's protocol ID
- FHP-TMD
- Status last verified
- Mar 2024
- First submitted
- 2 Nov 2023
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 37048735
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Forward Head Posture Correction Impact on Temporomandibular Dysfunction: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06123351
- Acronym / sponsor ID
- FHP-TMD
- Conditions
- Temporomandibular Disorder, Forward Head Posture
- Keywords
- Traction, Exercise, Pain, Temporomandibular dysfunction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Shima Abdollah Mohammad ZadehUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 8 Nov 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 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Permuted block randomization to ensure an equal number of allocations in each of the three groups (traditional, Denneroll cervical traction orthodontic and dental treatment). 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 |
|---|---|---|
| Denneroll protocol | Experimental | Device: Denneroll cervical traction orthodonticorthotic 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. |
| Traditional protocol | Active comparator | Other: stretching and strengthening exercisesconsists of one strengthening exercise for 10 repetitions in 3 sets each, and two stretching exercises with a hold for 20-30 seconds. |
| Dental management | Active comparator | Device: Vacuum-formed soft occlusal splintformed soft occlusal splint will be individually designed for the upper arch of each participant. |
Who may qualify
- Ages
- 18 to 50 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 |
|---|---|---|
| Denneroll cervical traction orthodontictraction for 3 to 15 minutes once daily | Device | Denneroll protocol |
| stretching and strengthening exercisesstrengthening exercises with 10 repetitions twice per day 3 times per week stretching exercises with hold for 20 to 30 seconds 3 repetitions daily | Other | Traditional protocol |
| Vacuum-formed soft occlusal splint2 mm thick elastic rubber sheets | Device | Dental management |
Primary outcome
Anamnestic questionnaire by Fonseca
Time frame: Baseline (pre-treatment) and week 7 (post-treatment)
To evaluate TMD by 10 questions with their corresponding scores from 0 to 1
Craniocervical angle - CVA
Time frame: Baseline (pre-treatment) 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) and week 7 (post-treatment)
Numerical Rating Scale (NRS)
Time frame: Baseline (pre-treatment) and week 7 (post-treatment)
Mandibular Opening
Time frame: Baseline (pre-treatment) and week 7 (post-treatment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 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.
- Individual participant dataSharing planned: No. No plan to make individual participant data (IPD) available to other researchers.
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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.
Tamer Shousha contact
Shima Mohammad zadeh study director
University of Sharjah
Tamer Shousha principal investigator
University of Sharjah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Denneroll cervical traction orthodontic, stretching and strengthening exercises and Vacuum-formed soft occlusal splint in people with Temporomandibular Disorder and Forward Head Posture, run by Shima Abdollah Mohammad Zadeh at 1 site 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: opening soon, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shima Mohammad Zadeh (+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) 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 NCT06123351, which also lists 7 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 15 Mar 2024.