Temporomandibular DisorderNCT04374682
Effectiveness of a Home Based Exercise Program on Temporomandibular Dysfunction Syndrome
An observational study of Temporomandibular Disorder, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Temporomandibular Disorder
- What is being tested?
- exercises
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2020to 30 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: patients with chronic Temporomandibular pain refractory to medical treatment
Who may be able to join
- patients suffering painful temporomandibular joint
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Home Based Exercise Program on Temporomandibular Dysfunction Syndrome: A Pilot Study in a Tertiary Care Hospital.
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.
Read the detailed description
Each patient was seen by the rheumatologist who did the following; Full history taking including special habits like chewing gums or biting nails, Pain level measured by visual analogue scale 100 (both at rest and during temporomandibular joint movement) Clinical Examination of the temporomandibular joint including localized tenderness and amount of mouth opening After that the patients were prescribed the rehabilitation program in the form of heat modalities and Transcutaneous electric nerve stimulation on the on the temporomandibular joint, given an individual demonstration of the home based exercises and were given a reminding handout.
The rehabilitation program consisted of the following exercises: lateral deviation, protrusion/retraction and mandibular opening.
Isometric cervical muscle strengthening exercises were also prescribed for the patients.
Assessment of the severity of temporomandibular joint affection using the Fonseca's questionnaire were done twice; the first at the entry point to the study and once again after 6 months.
- Conditions
- Temporomandibular Disorder
- Being tested
- exercises
- Keywords
- Temporomandibular dysfunction, Exercise, treatment, pain
- 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.
exercisesOther
stretching exercises - physiotherapy modalities - self care instructions
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue scale for pain during rest and on moving the jaw
visual analogue scale 0-100 with higher score indicating more pain.
Measured: 6 months
mouth opening
Distance between the edges of central incisors was measured. Measures are compared pre and post exercises.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start1 Mar 2020
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular DisorderStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, safaa Mahran, Assiut University
- Investigators
- Safaa A Mahran, MD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04374682
- Sponsor's protocol ID
- 17300389
- Status last verified
- Jul 2020
- First submitted
- 30 Apr 2020
- Last updated
- 10 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: studying the effectiveness of stretching exercises on chronic temporomandibular dysfunction syndrome refractory to medical treatment
Publications
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.
PubMed 28344938Kato 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.
PubMed 19089044Cascos-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.
PubMed 19114953Carvalho 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.
PubMed 19565312
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Home Based Exercise Program on Temporomandibular Dysfunction Syndrome: A Pilot Study in a Tertiary Care Hospital.
- ClinicalTrials.gov ID
- NCT04374682
- Acronym / sponsor ID
- 17300389
- Conditions
- Temporomandibular Disorder
- Keywords
- Temporomandibular dysfunction, Exercise, treatment, pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 5 May 2020 (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.
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.
Detailed description
Each patient was seen by the rheumatologist who did the following; Full history taking including special habits like chewing gums or biting nails, Pain level measured by visual analogue scale 100 (both at rest and during temporomandibular joint movement) Clinical Examination of the temporomandibular joint including localized tenderness and amount of mouth opening After that the patients were prescribed the rehabilitation program in the form of heat modalities and Transcutaneous electric nerve stimulation on the on the temporomandibular joint, given an individual demonstration of the home based exercises and were given a reminding handout.
The rehabilitation program consisted of the following exercises: lateral deviation, protrusion/retraction and mandibular opening.
Isometric cervical muscle strengthening exercises were also prescribed for the patients.
Assessment of the severity of temporomandibular joint affection using the Fonseca's questionnaire were done twice; the first at the entry point to the study and once again after 6 months.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- patients with chronic Temporomandibular pain refractory to medical treatment
Key inclusion criteria (1 listed)
- patients suffering painful temporomandibular joint
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| exercisesstretching exercises - physiotherapy modalities - self care instructions | Other | – |
Primary outcome
visual analogue scale for pain during rest and on moving the jaw
Time frame: 6 months
visual analogue scale 0-100 with higher score indicating more pain.
mouth opening
Time frame: 6 months
Distance between the edges of central incisors was measured. Measures are compared pre and post exercises.
Fonseca's scale.
Time frame: 6 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2020.
- Background: PubMed 28344938Eweka 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.
- Background: PubMed 19089044Kato 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.
- Background: PubMed 19114953Cascos-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.
- Background: PubMed 19565312Carvalho 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.
- Individual participant dataSharing planned: No. studying the effectiveness of stretching exercises on chronic temporomandibular dysfunction syndrome refractory to medical treatment
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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. This study is not recruiting at the moment.
Safaa A Mahran, MD principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Temporomandibular Disorder, run by Assiut University at 1 site in Egypt.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 10 Jul 2020. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analogue scale for pain during rest and on moving the jaw (time frame: 6 months). The study lists 3 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 NCT04374682, which also lists 4 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 10 Jul 2020.