Studying jaw joint problems in completely edentulous Syrian patients before and after receiving new full dentures
| ISRCTN | ISRCTN11645832 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11645832 |
- Submission date
- 09/06/2025
- Registration date
- 10/06/2025
- Last edited
- 10/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
This study aims to examine problems in the jaw joint (called the temporomandibular joint, or TMJ) in patients who have lost all their teeth (edentulous). Many completely edentulous patients wear old or poorly fitting dentures, which may lead to pain, joint sounds, or difficulty moving the jaw. The study aims to assess whether providing a new complete denture improves these symptoms.
Who can participate?
Completely edentulous patients aged 30 to 90 years who were already wearing old complete dentures and had symptoms related to the TMJ.
What does the study involve?
Participants underwent a clinical examination to assess pain, joint sounds, and jaw movement before and 6 months after receiving a new complete denture. The dentures were made according to proper dental standards. No medications or surgical treatments were involved.
What are the possible benefits and risks of participating?
Participants may experience relief from jaw pain, improved chewing function, and better denture comfort. There are no known medical risks, as the intervention is non-invasive and follows standard dental procedures.
Where is the study run from?
The study was conducted at the Faculty of Dentistry, Damascus University, Syria.
When is the study starting and how long is it expected to run for?
January 2021 to May 2024
Who is funding the study?
The study is self-funded as part of a postgraduate academic project and is supported by Damascus University, Syria.
Who is the main contact?
Dr. Yusra Abdulaziz Al-Kurdi, Faculty of Dentistry, Damascus University, yusraalkurdy9@gmail.com
Contact information
Public, Scientific, Principal Investigator
Faculty of Dentistry, Damascus University
Damascus
00000
Syria
 ORCID ID |
0009-0001-1874-1670 |
|---|---|
| Phone | +963 0969014495 |
| yusraalkurdy9@gmail.com |
Study information
| Study design | Single-centre non-randomized unblinded uncontrolled interventional pre–post study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital, 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 | Evaluation of the prevalence of temporomandibular disorders in completely edentulous Syrian patients before and after the delivery of new complete dentures: a clinical study |
| Study objectives | The study hypothesizes that the insertion of a new, properly constructed complete denture will significantly reduce temporomandibular joint (TMJ) symptoms, including joint pain, joint sounds, and restricted mandibular movement, in completely edentulous Syrian patients. |
| Ethics approval(s) | Ethics approval not required |
| Ethics approval additional information | This is a retrospectively registered, observational study. No clinical intervention was performed. Accordingly, no formal ethics committee approval was required by the institution. However, all participants signed written informed consent forms before being included in the study. |
| Health condition(s) or problem(s) studied | Temporomandibular disorders (TMD) in completely edentulous patients requiring new complete dentures |
| Intervention | This is a retrospectively registered, single-centre interventional pre–post clinical study conducted to assess the impact of new complete denture insertion on temporomandibular joint (TMJ) symptoms in completely edentulous Syrian patients. The intervention involves delivering a new, complete, and removable denture to completely edentulous Syrian patients. The dentures are fabricated according to prosthodontic standards to ensure proper fit, retention, occlusion, vertical dimension, and centric relation. There is no control group, no randomization, and no blinding. All participants will be examined before and after the intervention. The follow-up period is six months, during which TMJ symptoms will be clinically evaluated. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Complete removable denture |
| Primary outcome measure | Temporomandibular joint symptoms (pain, joint sounds, movement limitation) measured using clinical examination based on RDC/TMD Axis I at baseline and after 6 months of new denture use |
| Secondary outcome measures | The following Secondary outcome measures are assessed at baseline and after 6 months: 1. Pain severity measured using the Visual Analog Scale (VAS) 2. Range of mandibular movement measured using a millimeter ruler 3. Muscle tenderness measured using digital palpation, according to RDC/TMD Axis I criteria |
| Overall study start date | 01/01/2021 |
| Completion date | 30/11/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 30 Years |
| Upper age limit | 90 Years |
| Sex | Both |
| Target number of participants | 103 |
| Total final enrolment | 103 |
| Key inclusion criteria | 1. Completely edentulous patients (both maxilla and mandible) 2. Aged between 30 and 90 years 3. Wearing old, removable complete dentures 4. Complaining of temporomandibular joint symptoms (pain, sounds, movement limitation) 5. Willing and able to participate in clinical examination and follow-up |
| Key exclusion criteria | 1. Patients with a history of TMJ trauma or surgery 2. Patients with systemic joint diseases 3. Patients with incomplete records or who missed follow-up visits 4. Patients with psychological or neuromuscular disorders affecting TMJ assessment |
| Date of first enrolment | 10/09/2021 |
| Date of final enrolment | 30/05/2024 |
Locations
Countries of recruitment
- Syria
Study participating centre
Damascus
-
Syria
Sponsor information
University/education
Mazzah
Damascus
...
Syria
| Website | https://www.damascusuniversity.edu.sy/ |
|---|---|
"ROR" |
https://ror.org/03m098d13 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Damascus, جَامِعَةُ دِمَشْقَ, DU
- Location
- Syria
Results and Publications
| Intention to publish date | 12/12/2024 |
|---|---|
| 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 and possible presentation in scientific conferences. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Dr. Yusra Abdulaziz Al-Kurdi (yusraalkurdy9@gmail.com). Data will be anonymised and shared with qualified researchers upon reasonable request for academic purposes only. Participant consent was obtained, and ethical approval was granted for data use in this context. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 10/06/2025 | No | No |
Additional files
Editorial Notes
10/06/2025: Study's existence confirmed by the Department of Removable Prosthodontics, Faculty of Dental Medicine, Damascus University.
