NCT06707467

Brief Summary

Fifty-seven patients diagnosed with internal temporomandibular derangement will be included in the study and divided into three groups. All patients will be treated with a proven-effective occlusal splint. The first group will receive only occlusal splint therapy and will serve as the control group. The second group will receive occlusal splint therapy combined with Rocabado exercises, while the third group will receive occlusal splint therapy combined with postural exercises. Before the treatment process, all patients will complete the Temporomandibular Disorders Diagnostic Criteria (TMD-DC) form. Pain intensity will be measured using the Visual Analog Scale (VAS), pain thresholds will be assessed using an algometer, and the following evaluations will be performed: Cervical Posture Assessment (Craniovertebral Angle with Goniometer)-Cervical Range of Motion Assessment (C-ROM)-Cervical Deep Flexor Muscle Endurance Test-Neck Disability Assessment (NDI - Neck Disability Index)-Psychiatric Assessment (HADS - Hospital Anxiety and Depression Scale). After two months, patients will be recalled, and all tests will be repeated. The effectiveness of the three treatment protocols will then be evaluated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2024

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2024

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 27, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

10 months

First QC Date

November 21, 2024

Last Update Submit

January 18, 2026

Conditions

Keywords

temporomandibular disordersrocabadoocclusal splintsposture excercise

Outcome Measures

Primary Outcomes (2)

  • Investigation of the Effect of Postural Exercises and Rocabado Exercises on Pain Reduction

    Three different treatment protocols will be applied to patients with internal temporomandibular derangement, and the results obtained after a 2-month treatment period will be compared to determine which method is the most effective. To evaluate treatment outcomes, the patients' pre- and post-treatment Visual Analog Scale (VAS) scores will be assessed, with a decrease in the mean VAS score indicating a reduction in pain. Additionally, the pain threshold in various facial regions will be measured with an algometer before and after treatment to identify which treatment protocol is more effective in reducing pain. By combining both outcomes, the most effective method for pain reduction will be determined.

    2 months

  • Investigation of the Effect of Postural Exercises and Rocabado Exercises on Physiological Movements

    Changes in cervical range of motion (C-ROM) and the craniovertebral angle will also be evaluated to determine the impact of the treatment methods on these parameters. In this way, the method that is more effective in improving physiological movements will be identified.

    2 months

Secondary Outcomes (2)

  • Investigation of the Secondary Effects of Postural Exercises and Rocabado Exercises on Patient's Psychology

    2 months

  • Investigation of the Effect of Postural Exercises and Rocabado Exercises on the Mobility of the Neck and Jaw

    2 month

Study Arms (3)

nineteen patients with internal temporomandibular disarrangement-group 1

EXPERIMENTAL

Nineteen randomly selected patients with internal temporomandibular disarrangement

Other: occlusal splints combined with rocabado exercise

nineteen patients with internal temporomandibular disarrangement-group 2

ACTIVE COMPARATOR

nineteen randomly selected patients with internal temporomanidbular disarrangement

Other: occlusal splint

nineteen patients with internal temporomandibular disarrangement-group 3

EXPERIMENTAL

nineteen selected patients with internal temporomandibular disarrangements

Other: occlusal splint combined with posture exercise

Interventions

Nineteen patients diagnosed with internal temporomandibular derangement will be provided with posture exercises in addition to the proven-effective treatment method of occlusal splint therapy. This approach aims to evaluate whether posture exercises have a positive effect on the treatment process.

nineteen patients with internal temporomandibular disarrangement-group 3

nineteen patients diagnosed with internal temporomandibular derangement will receive occlusal splint therapy, a treatment method with proven effectiveness.

nineteen patients with internal temporomandibular disarrangement-group 2

Nineteen patients diagnosed with internal temporomandibular derangement will be provided with Rocabado exercises in addition to the proven-effective treatment method of occlusal splint therapy. This approach aims to evaluate whether Rocabado exercises have a positive effect on the treatment process.

nineteen patients with internal temporomandibular disarrangement-group 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being diagnosed with internal temporomandibular disarrangement
  • aged 18 years or older
  • Willingness to participate in the study
  • Ability to speak and understand Turkish, with no communication difficulties severe enough to impede understanding of the exercises

You may not qualify if:

  • History of acute trauma in the TMJ or surrounding area
  • TMJ dysfunction caused by a neurological condition
  • History of surgical/invasive procedures or treatments on the TMJ
  • Presence of infection or tumoral structures within intraoral structures
  • History of tooth loss or use of dental prostheses
  • History of surgical procedures in the cervical region

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Occlusal Splints

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Orthotic DevicesOrthopedic EquipmentSurgical EquipmentEquipment and Supplies

Study Officials

  • Ebru K Mutlu, Clinical Prof.

    Bandırma Onyedi Eylül University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients with internal temporomandibular derangement are divided into three groups. The first group receives only occlusal splint therapy. The second group undergoes occlusal splint therapy combined with Rocabado exercises, while the third group is treated with occlusal splint therapy combined with postural exercises. The effectiveness of the treatment protocols is evaluated.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD DDS Research Assistant

Study Record Dates

First Submitted

November 21, 2024

First Posted

November 27, 2024

Study Start

November 1, 2024

Primary Completion

September 1, 2025

Study Completion

September 1, 2025

Last Updated

January 21, 2026

Record last verified: 2026-01

Locations