NCT06123351

Brief 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 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
19mo left

Started Oct 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress28%
Oct 2025Dec 2027

First Submitted

Initial submission to the registry

November 2, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 8, 2023

Completed
1.9 years until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

2.2 years

First QC Date

November 2, 2023

Last Update Submit

March 14, 2024

Conditions

Keywords

TractionExercisePainTemporomandibular dysfunction

Outcome Measures

Primary Outcomes (2)

  • Anamnestic questionnaire by Fonseca

    To evaluate TMD by 10 questions with their corresponding scores from 0 to 1

    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

    Baseline (pre-treatment) and week 7 (post-treatment)

Secondary Outcomes (3)

  • Boley Gauge

    Baseline (pre-treatment) and week 7 (post-treatment)

  • Numerical Rating Scale (NRS)

    Baseline (pre-treatment) and week 7 (post-treatment)

  • Mandibular Opening

    Baseline (pre-treatment) and week 7 (post-treatment)

Study Arms (3)

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.

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.

Other: stretching and strengthening exercises

Dental management

ACTIVE COMPARATOR

formed soft occlusal splint will be individually designed for the upper arch of each participant.

Device: Vacuum-formed soft occlusal splint

Interventions

traction for 3 to 15 minutes once daily

Denneroll protocol

strengthening exercises with 10 repetitions twice per day 3 times per week stretching exercises with hold for 20 to 30 seconds 3 repetitions daily

Traditional protocol

2 mm thick elastic rubber sheets

Dental management

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Previous head, neck or TMJ traumas.
  • History of temporomandibular joint surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sharjah

Sharjah city, 0000, United Arab Emirates

Location

Related Publications (7)

  • Lee WY, Okeson JP, Lindroth J. The relationship between forward head posture and temporomandibular disorders. J Orofac Pain. 1995 Spring;9(2):161-7.

    PMID: 7488986BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 26436048BACKGROUND
  • El-Hamalawy FA. Forward head correction exercises for management of myogenic tempromandibular joint dysfunction. 2011;7(8)

    BACKGROUND
  • 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.

    PMID: 34109357BACKGROUND
  • 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.

    PMID: 36776487BACKGROUND
  • 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.

    PMID: 37048735BACKGROUND

MeSH Terms

Conditions

Temporomandibular Joint DisordersMotor ActivityPain

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic DiseasesBehaviorNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Shima Mohammad zadeh

    University of Sharjah

    STUDY DIRECTOR
  • Tamer Shousha

    University of Sharjah

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shima Mohammad Zadeh

CONTACT

Tamer Shousha

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single blinded study where the participants will be blinded to the study different groups and the study hypothesis.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 2, 2023

First Posted

November 8, 2023

Study Start

October 1, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

March 15, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

No plan to make individual participant data (IPD) available to other researchers.

Locations