NCT04374682

Brief Summary

patients with chronic refractory temporomandibular dysfunction were prescribed home exercise and were followed for 6 months. Pain , mouth opening and Fonseca's were done at day 1 and after 6 months of the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

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

March 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 5, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

July 10, 2020

Status Verified

July 1, 2020

Enrollment Period

4 months

First QC Date

April 30, 2020

Last Update Submit

July 9, 2020

Conditions

Temporomandibular Disorder

Keywords

Temporomandibular dysfunctionExercisetreatmentpain

Outcome Measures

Primary Outcomes (3)

  • visual analogue scale for pain during rest and on moving the jaw

    visual analogue scale 0-100 with higher score indicating more pain.

    6 months

  • mouth opening

    Distance between the edges of central incisors was measured. Measures are compared pre and post exercises.

    6 months

  • Fonseca's scale.

    It is composed of 10 questions, which include checking for the presence of pain in temporomandibular joint, head, back, and while chewing, parafunctional habits, movement limitations, joint clicking, perception of malocclusion, and sensation of emotional stress. The volunteers were informed that the 10 questions should be answered with "yes", "no" and "sometimes" and that only one answer should be marked for each question. Scoring ranges between 0-50 with higher score indicating worse results.

    6 months

Interventions

exercisesOTHER

stretching exercises - physiotherapy modalities - self care instructions

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

patients with chronic Temporomandibular pain refractory to medical treatment

You may qualify if:

  • patients suffering painful temporomandibular joint

You may not qualify if:

  • Patients with history of face trauma
  • Patients with surgery at the temporomandibular joint
  • Dental procedure in the last 6 months period
  • Patients with rheumatic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, 71515, Egypt

Location

Related Publications (4)

  • Eweka OM, Ogundana OM, Agbelusi GA. TEMPOROMANDIBULAR PAIN DYSFUNCTION SYNDROME IN PATIENTS ATTENDING LAGOS UNIVERSITY TEACHING HOSPITAL, LAGOS, NIGERIA. J West Afr Coll Surg. 2016 Jan-Mar;6(1):70-87.

    PMID: 28344938BACKGROUND

  • Kato MT, Kogawa EM, Santos CN, Conti PC. TENS and low-level laser therapy in the management of temporomandibular disorders. J Appl Oral Sci. 2006 Apr;14(2):130-5. doi: 10.1590/s1678-77572006000200012.

    PMID: 19089044BACKGROUND

  • Cascos-Romero J, Vazquez-Delgado E, Vazquez-Rodriguez E, Gay-Escoda C. The use of tricyclic antidepressants in the treatment of temporomandibular joint disorders: systematic review of the literature of the last 20 years. Med Oral Patol Oral Cir Bucal. 2009 Jan 1;14(1):E3-7.

    PMID: 19114953BACKGROUND

  • Carvalho CM, de Lacerda JA, dos Santos Neto FP, Cangussu MC, Marques AM, Pinheiro AL. Wavelength effect in temporomandibular joint pain: a clinical experience. Lasers Med Sci. 2010 Mar;25(2):229-32. doi: 10.1007/s10103-009-0695-y. Epub 2009 Jun 30.

    PMID: 19565312BACKGROUND

MeSH Terms

Conditions

Temporomandibular Joint DisordersMotor ActivityPain

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Safaa A Mahran, MD

    Assiut University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Proffesor

Study Record Dates

First Submitted

April 30, 2020

First Posted

May 5, 2020

Study Start

March 1, 2020

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

July 10, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

studying the effectiveness of stretching exercises on chronic temporomandibular dysfunction syndrome refractory to medical treatment

Locations

EG(1)