Mouth sores from dentures in older adults in the UAE: how common are they and what causes them
ISRCTN | ISRCTN76287118 |
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DOI | https://doi.org/10.1186/ISRCTN76287118 |
Secondary identifying numbers | MOHAP/DXB-REC/ J.J.J /No.78 / 2023 |
- Submission date
- 17/12/2024
- Registration date
- 28/12/2024
- Last edited
- 27/12/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Denture stomatitis refers to sores that form on the soft tissues of the mouth, often affecting people who wear removable dentures. These sores can appear as small, isolated sore spots, larger red patches, or even areas of soft tissue growth, commonly on the roof of the mouth. The goal of this study is to find out how common denture stomatitis is among older adults in the UAE who wear removable dentures. In addition, the study will look at which factors may lead to the development or worsening of these sores. By better understanding this condition, we hope to help health officials plan ways to prevent and manage it more effectively.
Who can participate?
Men and women who are 50 years of age or older, who have been wearing removable dentures for at least 1 year
What does the study involve?
If you choose to participate, you will have a standard dental examination of your mouth using a simple mouth mirror and a dental explorer. You will also be asked to complete a brief questionnaire about your general health, dental and denture history, and oral hygiene habits.
What are the possible benefits and risks of participating?
There are no known risks to participating in this study. Although you will not receive any direct personal benefit, the information we gather will be valuable to the community. It will help us understand how common these sores are and what causes them, and in turn, assist government health agencies in developing plans to manage and prevent this condition in the future.
Where is the study run from?
Ras Al Khaimah Specialized Dental Center (United Arab Emirates)
When is the study starting and how long is it expected to run for?
May 2023 to June 2025
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Nabeel Alsabeeha, nabeel.galeb@ehs.gov.ae
Contact information
Public, Scientific, Principal Investigator
RAK Specialized Dental Center
Ras Al Khaimah
PO Box 3071
United Arab Emirates
0000-0003-2003-3494 | |
Phone | +971 (0)504433772 |
nabeel.galeb@ehs.gov.ae |
Study information
Study design | Observational cross-sectional study |
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Primary study design | Observational |
Secondary study design | Cross sectional study |
Study setting(s) | Dental clinic |
Study type | Diagnostic, Screening |
Participant information sheet | Not available in web format, please use contact details to request a participants information sheet. |
Scientific title | Denture stomatitis in older adult population in the United Arab Emirates: a cross-sectional study on prevalence and associated risk factors |
Study objectives | What is the prevalence rate of denture stomatitis among older adult denture wearers in the UAE, and what are its associated risk factors? |
Ethics approval(s) |
Approved 21/06/2023, Ministry of Health and Prevention Research Ethics Committee (Muhaisna 2, SMBZ Road, Dubai, PO Box 3071, United Arab Emirates; +971 (0)8001111; info@mohap.gov.ae), ref: MOHAP/DXB-REC/ J.J.J /No.78 / 2023 |
Health condition(s) or problem(s) studied | Denture stomatitis |
Intervention | A sample of older adults (aged >50 years) will be clinically examined for the presence of denture stomatitis. Additionally, each participant will be required to fill up a structured questionnaire to collect relevant information including demographic data, medical and dental histories, habits, and denture history, usage and hygiene. The participant's existing denture will also be examined to evaluate its quality based on standard criteria. |
Intervention type | Other |
Primary outcome measure | The prevalence rate of denture stomatitis in the target population, determined by direct clinical examination to identify the affected individual and the type of condition. Measured at a single timepoint for each participant. |
Secondary outcome measures | Risk factors for denture stomatitis determined from medical history and structured questionnaires. Measured at a single timepoint for each participant. |
Overall study start date | 01/05/2023 |
Completion date | 30/06/2025 |
Eligibility
Participant type(s) | Patient, Service user |
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Age group | Senior |
Lower age limit | 50 Years |
Upper age limit | 90 Years |
Sex | Both |
Target number of participants | 500 |
Key inclusion criteria | 1. Male or female patients 50 years and above 2. Wearing removable partial and/or complete dentures for at least 1 year 3. Willing to comply with research visits and follow-up as needed 4. Able to provide informed consent |
Key exclusion criteria | 1. Patients with denture use of less than 1 year 2. Patients under radiotherapy or immunosuppressive medications 3. Patients with mental illness or drug abuse 4. Patients unable to provide informed consent |
Date of first enrolment | 23/12/2024 |
Date of final enrolment | 30/06/2025 |
Locations
Countries of recruitment
- United Arab Emirates
Study participating centre
Ras Al Khaimah
PO Box 3071
United Arab Emirates
Sponsor information
Government
Muhaisna 2, SMBZ Road
Dubai
PO Box 3071
United Arab Emirates
Phone | +971 (0)80011111 |
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info@mohap.gov.ae | |
Website | https://mohap.gov.ae/en |
Funders
Funder type
Other
No information available
Results and Publications
Intention to publish date | 01/12/2025 |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not expected to be made available |
Publication and dissemination plan | Planned publication in peer reviewed journal towards the end of 2025, once results collected, analyzed, and manuscript drafted and approved by auhtors. |
IPD sharing plan | The datasets generated and/or analyzed during the current study are not expected to be made available due to data protection regulations. |
Editorial Notes
18/12/2024: Study's existence confirmed by Ministry of Health and Prevention Research Ethics Committee.