How ear symptoms affect recovery from jaw disorders using non-drug non-surgical treatment

ISRCTN	ISRCTN49976724
DOI	https://doi.org/10.1186/ISRCTN49976724
Secondary identifying numbers	REC002

Submission date: 21/09/2024
Registration date: 24/09/2024
Last edited: 21/02/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Temporomandibular disorder (TMD) affects the jaw joint and can cause a variety of symptoms, including jaw pain, difficulty chewing, and limited movement of the jaw. Sometimes, TMD also causes ear-related symptoms like ear pain and ringing in the ears (tinnitus). This study aims to evaluate how ear symptoms can affect recovery from TMD when treated with physiotherapy and occlusal splints.

Who can participate?
Males and females of any age can participate if they have a temporomandibular disorder (TMD). In case of ear-related symptoms, a medical report will be needed from an ENT specialist to exclude that the ear is the origin of the symptoms.

What does the study involve?
After diagnosis, a treatment plan will be established which will include physiotherapy and an occlusal splint.
All participants receive the same type of treatment. The treatment will be individual according to the needs listed in the treatment plan.
The doctor will measure the pain and other symptoms before and after 3 months of the beginning of the treatment.

What are the possible benefits and risks of participating?
The benefits are the partial/complete healing of the symptoms. The treatment is very safe. Some people may experience mild discomfort or pain when starting physiotherapy exercises or wearing an occlusal splint. Also, the jaw muscles may feel sore as they adjust to new movements or the use of a splint. Finally, wearing a splint can sometimes cause a temporary change in how teeth fit together when biting.

Where is the study run from?
Al-Sham private university ASPU, faculty of Dentistry (Syria)

When is the study starting and how long is it expected to run for?
September 2024 to February 2025

Who is funding the study?
This study publication is financially supported by the doctor leading it. The patient will pay for the treatment.

Who is the main contact?
Dr. Samer Al Akkad, DDS, MSc, Ph.D.
Dr.samerakkad@gmail.com

Contact information

Dr Samer Al Akkad
Public, Principal Investigator

Al-Sham private university ASPU, Faculty of Dentistry
Damascus
0100
Syria

ORCID ID	0009-0009-3578-9770
Phone	+963 11 215 3360
Email	Dr.samerakkad@gmail.com

Dr Marwan AL AKKAD
Scientific

Faculty of Medicine and Dentistry, Palacký University Olomouc
Hněvotínská 3
Olomouc
775 15
Czech Republic

ORCID ID	0000-0001-8164-5940
Phone	+420 720358653
Email	Akkadian@web.de

Study information

Study design	Single-center interventional non-randomized clinical trial
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	University/medical school/dental school
Study type	Treatment
Participant information sheet	Not available in web format. Please use contact details to request a participant information sheet
Scientific title	Comparison between the prognosis of TMD with and without accompanying otologic symptoms after non-invasive non-pharmacological treatment
Study acronym	TMD-POS
Study objectives	Null hypothesis: there is no significant relation between the prognosis of TMD and the accompanying otologic symptoms.
Ethics approval(s)	Approved 09/09/2024, The Research Ethics Committee (RLC) at Al-Sham private university (Al-Baramkeh, Musab Bin Omair Street - next to Tishreen Stadium, Damascus, 0100, Syria; +963 11 215 3360; info@aspu.edu.sy), ref: REC002
Health condition(s) or problem(s) studied	Temporomandibular disorder (TMD)
Intervention	Both groups of patients will get the same type of intervention. Patients having TMD with accompanying otologic symptoms are allocated to one group, while patients having TMD without accompanying otologic symptoms are allocated to another group. The intervention is non-invasive in the form of physiotherapy and occlusal splints. 1- Physiotherapy includes: a- massage b- hot compress d- infrared radiation c- stretching exercises for the joint capsule and ligament in cases of joint compression. 2-Occlusal splints: They will be fabricated using a conventional technique based on initial diagnostic impressions of the maxillary and mandibular arches with alginate material and on a wax bite to record the desired jaw position for the splint. The study itself will finish after three months but the intervention will last up to 6 months, depending on the improvement in the condition of the TMD of each patient individually. This means that some patients might finish earlier.
Intervention type	Mixed
Primary outcome measure	1. The initial symptoms of a TMD and the accompanying otologic symptoms (if present) are recorded during the diagnosis 2. Improvement in symptoms of a TMD and in symptoms of the accompanying otologic symptoms are then recorded after a 3-month follow-up 3. In case one of the symptoms is pain, the Visual Analogue Scale (VAS) will be used to determine the amount of pain that a patient feels 4. The diagnosis, treatment, and follow-up phases will be done by the same experienced TMJ specialist Dr. Samer Al Akkad
Secondary outcome measures	There are no secondary outcome measures
Overall study start date	09/09/2024
Completion date	01/02/2025

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	40
Total final enrolment	40
Key inclusion criteria	1. Having TMD only or having TMD with accompanying otologic symptoms. 2. If otologic symptoms are present, the patient should be referred by an ENT specialist who confirms a non-otologic origin of the symptoms.
Key exclusion criteria	1. Having TMD with otologic symptoms of otologic origins
Date of first enrolment	01/10/2024
Date of final enrolment	01/11/2024

Locations

Countries of recruitment

Syria

Study participating centre

Al-Sham private university ASPU, Faculty of Dentistry

Al Mazraa - next to Al Iman Mosque.
Damascus
0100
Syria

Sponsor information

Al-Sham private university ASPU
University/education

AlBaramkeh, Musab Bin Omair Street - next to Tishreen Stadium.
Damascus
0100
Syria

Phone	+963 11 215 3360
Email	info@aspu.edu.sy
Website	https://aspu.edu.sy

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date	01/04/2025
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication in a peer-reviewed journal
IPD sharing plan	The datasets genersated during and/or analysed during the current study will be available upon request from Dr. Samer Al Akkad. Email: Dr.samerakkad@gmail.com

Editorial Notes

21/02/2025: Total final enrolment added.
28/10/2024: Ethics approval details added.
23/09/2024: Trial's existence confirmed by the Research Ethics Committee (RLC) at Al-Sham private university.