NCT07403357

Brief Summary

The study was conducted to determine the effects of stomatognathic alignment exercise program in craniomandibular dysfunction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

June 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 11, 2026

Completed
Last Updated

February 11, 2026

Status Verified

February 1, 2026

Enrollment Period

6 months

First QC Date

February 4, 2026

Last Update Submit

February 4, 2026

Conditions

Keywords

functional disabilityTemporomandibular jointForward head postureMyofascial releaseStomatognathic Alignment ExerciseStomatognathic diseaseCraniomandibular Dysfunction

Outcome Measures

Primary Outcomes (2)

  • Numeric Pain Rating Scale

    Numeric Pain Rating Scale is utilized to evaluate pain. It consists of 11 points, having an overall score ranging from 0 to 10, where; 0 represents no pain, 1 to 3 represents mild pain, 4 to 6 represents moderate pain and 7 to 10 represents the most severe pain.

    From enrollment until the end of treatment at the fourth week.

  • Mandibular function impairment questionnaire

    MFIQ is used to evaluate the degree of jaw function impairment in TMJD patients. Two dimensions and 17 questions make up this questionnaire, which assigns a score ranging from 0 (no problem) to 4 (extreme difficulty or impossible without support) for a certain jaw function. The "functional capacity" dimension is made up of the first eleven components, whereas the "nutrition" dimension is made up of the next six. A high degree of jaw function impairment is indicated by a high overall score on the questionnaire.

    From enrollment until the end of treatment at the fourth week.

Secondary Outcomes (11)

  • ROM Cervical Spine (Felxion)

    From enrollment until the end of treatment at the fourth week

  • ROM Cervical Spine (Extension)

    From enrollment until the end of treatment at the fourth week.

  • ROM Cervical Spine (Lateral Flexion) Left Side

    From enrollment until the end of treatment at the fourth week.

  • ROM Cervical Spine (Lateral Flexion) Right Side

    From enrollment until the end of treatment at the fourth week.

  • ROM Cervical Spine (Rotation) Left Side

    From enrollment until the end of treatment at the fourth week.

  • +6 more secondary outcomes

Study Arms (2)

Stomatognathic alignment exercise program along with standard physical therapy

EXPERIMENTAL

Stomatognathic alignment exercise program along with standard treatment.

Other: Stomatognathic Alignment Exercise ProgramOther: Standard Physical therapy treatment

Traditional physical therapy

ACTIVE COMPARATOR

Myofascial release of masticatory muscles and heating pad at cervical.

Other: Standard Physical therapy treatment

Interventions

Chin Tuck Exercise: Starting position: Supine and standing against a wall. Tuck chin backward over the sternal notch to place the patient's ears in line with the tips of the shoulders. Repetitions: Supine: Ten repetitions of a 10-second hold. Standing against a wall: Two repetitions of a 5-minute hold. Anterior Chest Stretching Exercise: Starting position: Standing against a wall with a flattened back; arms at 45° shoulder abduction with elbow in full extension. Active ROM exercises of neck and TMJ: Starting position: Sitting in a back-supported chair. Neck motions: flexion, extension, lateral flexion, and rotation. TMJ: Mouth opening, lateral excursion, and protrusion. Repetitions: A 10-second hold at the end range of each motion. Two series of ten repetitions for each motion. Standard physiotherapy including hot pack and myofascial release of masticatory muscles. A total of 12 sessions were conducted for 4 weeks with 3 sessions scheduled each week.

Stomatognathic alignment exercise program along with standard physical therapy

Control Group received only standard physiotherapy including hot pack and myofascial release of masticatory muscles. A total of 12 sessions were conducted for 4 weeks with 3 sessions scheduled each week.

Stomatognathic alignment exercise program along with standard physical therapyTraditional physical therapy

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female with age group of 20-65 years.
  • Patients diagnosed with temporomandibular dysfunction
  • Individuals with the sedentary life style
  • Craniovertebral angle \<50 degrees
  • Patients who presented with at least one symptom of temporomandibular dysfunction, able to communicate effectively, cooperative with imaging examinations, and able to complete the prescribed treatment and patients with no contraindications for the required examinations or treatments.

You may not qualify if:

  • Serious musculoskeletal problems of cervical and thoracic spine
  • Neurological disease affecting balance and postural control
  • Dental prosthesis
  • Disc prolapsed
  • Previous surgery in TMJ area
  • Vertebral artery compromise test
  • Cerebrovascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fatima Memorial Hospital (Oral & Maxillofacial Surgery Department)

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (10)

  • Oh DW, Kang TW, Kim SJ. Effect of stomatognathic alignment exercise on temporomandibular joint function and swallowing function of stroke patients with limited mouth opening. J Phys Ther Sci. 2013;25(10):1325-9

    BACKGROUND
  • Pundkar S, Patil D, Naqvi W. A Comparative Study on Effectiveness of Rocabado Approach and Conventional Physiotherapy on Pain, ROM and QOL in Patients with TMJ Dysfunction. Journal of Pharmaceutical Research International. 2021;33(58B):201-9

    BACKGROUND
  • Byra J, Kulesa-Mrowiecka M, Pihut M. Physiotherapy in hypomobility of temporomandibular joints. Folia Med Cracov. 2020;60(2):123-34

    BACKGROUND
  • Oleksy Ł, Kielnar R, Mika A, Jankowicz-Szymańska A, Bylina D, Sołtan J, et al. Impact of Cervical Spine Rehabilitation on Temporomandibular Joint Functioning in Patients with Idiopathic Neck Pain. Biomed Res Int. 2021;2021:6886373

    BACKGROUND
  • Yılmaz V, Aras B, Umay E. Temporomandibular Joint Dysfunction and Impaired Stomatognathic Alignment: A Problem Beyond Swallowing in Patients With Stroke. Indian J Otolaryngol Head Neck Surg. 2020;72(3):329-34

    BACKGROUND
  • Militi A, Bonanno M, Calabrò RS. It Is Time for a Multidisciplinary Rehabilitation Approach: A Scoping Review on Stomatognathic Diseases in Neurological Disorders. J Clin Med. 2023;12(10)

    BACKGROUND
  • de Oliveira-Souza AIS, do Valle Sales LR, de Fontes Coutinho AD, de Oliveira DA, Armijo-Olivo S. Effectiveness of an 8-week neck exercise training on pain, jaw function, and oral health-related quality of life in women with chronic temporomandibular disorders: a randomized controlled trial. J Oral Facial Pain Headache. 2024;38(1):40-51

    BACKGROUND
  • Ilhanlı M, Ilhanlı I, Aksakallı S. Effectiveness of Rocabado exercises in patients with rheumatoid arthritis in remission with temporomandibular joint involvement: A randomized-controlled study. Turk J Phys Med Rehabil. 2024;70(3):319-26

    BACKGROUND
  • O. W. Conservative Management of Temporomandibular Joint Dysfunction: A Case Report. Journal of Health Directories. 2024;1(1):16-23

    BACKGROUND
  • Yu LJ, Yan X, Kim TH. Effects of combined jaw and cervicoscapular exercises on mouth opening and muscle properties in cervical extension type. Sci Rep. 2025;15(1):19049.

    BACKGROUND

MeSH Terms

Conditions

Stomatognathic Diseases

Study Officials

  • Saba Rafique, MS.OMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2026

First Posted

February 11, 2026

Study Start

June 1, 2025

Primary Completion

November 30, 2025

Study Completion

November 30, 2025

Last Updated

February 11, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations