Mouth sores from dentures in older adults in the UAE: how common are they and what causes them

ISRCTN ISRCTN76287118
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

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

Dr Nabeel Alsabeeha
Public, Scientific, Principal Investigator

RAK Specialized Dental Center
Ras Al Khaimah
PO Box 3071
United Arab Emirates

ORCiD logoORCID ID 0000-0003-2003-3494
Phone +971 (0)504433772
Email nabeel.galeb@ehs.gov.ae

Study information

Study designObservational cross-sectional study
Primary study designObservational
Secondary study designCross sectional study
Study setting(s)Dental clinic
Study typeDiagnostic, Screening
Participant information sheet Not available in web format, please use contact details to request a participants information sheet.
Scientific titleDenture stomatitis in older adult population in the United Arab Emirates: a cross-sectional study on prevalence and associated risk factors
Study objectivesWhat 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) studiedDenture stomatitis
InterventionA 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 typeOther
Primary outcome measureThe 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 measuresRisk factors for denture stomatitis determined from medical history and structured questionnaires. Measured at a single timepoint for each participant.
Overall study start date01/05/2023
Completion date30/06/2025

Eligibility

Participant type(s)Patient, Service user
Age groupSenior
Lower age limit50 Years
Upper age limit90 Years
SexBoth
Target number of participants500
Key inclusion criteria1. 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 criteria1. 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 enrolment23/12/2024
Date of final enrolment30/06/2025

Locations

Countries of recruitment

  • United Arab Emirates

Study participating centre

RAK Specialized Dental Center
18 Al Mashfa Street, Al Juwais
Ras Al Khaimah
PO Box 3071
United Arab Emirates

Sponsor information

Ministry of Health and Prevention
Government

Muhaisna 2, SMBZ Road
Dubai
PO Box 3071
United Arab Emirates

Phone +971 (0)80011111
Email info@mohap.gov.ae
Website https://mohap.gov.ae/en

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date01/12/2025
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planPlanned publication in peer reviewed journal towards the end of 2025, once results collected, analyzed, and manuscript drafted and approved by auhtors.
IPD sharing planThe 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.