Oral Screening for Elderly in Aged Care HomesNCT05101681
Accuracy of Teledentistry Versus Direct Oral Examination for Elderly in Aged-Care Homes: A Pilot Cross-Sectional Study
An observational study of Oral Screening for Elderly in Aged Care Homes, run by Cairo University at 2 sites in Egypt.
Trial summary
The residents will receive oral health education, then three examiners ( licensed dentists ) will perform the direct oral examination of the participants. During the same visit, a dental student will take the intraoral photographs in the aged care home. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Oral Screening for Elderly in Aged Care Homes
- What is being tested?
- Teledentistry
- How many people
- 30 participants
- Where
- 2 sitesEgypt
- Study dates
- 31 Jan 2023to Dec 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The participants are elderly living in aged care homes in Egypt who must be able to communicate with the examiner and must be able to give consent to participate in the study.
Who may be able to join
- Elderly living in aged care homes in Egypt
- Have the ability to communicate with the examiner
- Have the ability to give consent to participate in the study.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 1 recruiting
- Completed
Dar El Sahwa Elderly Home
Giza
- Recruiting
Khadmat El Mogtamaa Elderly Home
Giza
Dalia
About this study
Official title: Diagnostic Accuracy of Teledentistry Versus Direct Oral Examination of Elderly in Aged-Care Homes: A Pilot Cross-Sectional Study
The residents will receive oral health education, then three examiners ( licensed dentists ) will perform the direct oral examination of the participants. During the same visit, a dental student will take the intraoral photographs in the aged care home.
Later, three different blinded examiners (licensed dentists) will assess the intraoral photographs of the same group of participants. The participant's dentition will be examined using the scores developed by the World Health Organization (WHO) for oral health surveys. Also, the examiners will perform a visual inspection of the oral mucosa for any signs of oral potentially malignant disorders (OPMD), as the mortality of high-risk populations is proven to be reduced by visual oral cancer screening.
Finally, the residents who require treatment will be referred to Kasr EL Ainy dental hospital to receive dental treatments.
Read the detailed description
The residents will receive oral health education, by three examiners ( licensed dentists ) with a t least 5 years experience. Then the same examiner will perform the direct oral examination of the participants. They will fill the dentition status, denture status, oral lesions and intervention urgency section of the World Health Organization (WHO) form 2013 version.
During the same visit, a dental student will take the intraoral photographs in the aged care home. The photographs will include 5 views (upper occlusal, lower occlusal , frontal, right lateral and left lateral).
The photographs will be uploaded on one drive and later, three different blinded examiners (licensed dentists) will assess the intraoral photographs of the same group of participants. The participant's dentition will be examined using the scores developed by the World Health Organization (WHO) for oral health surveys. Also, the examiners will perform a visual inspection of the oral mucosa for any signs of oral potentially malignant disorders (OPMD), as the mortality of high-risk populations is proven to be reduced by visual oral cancer screening.
Finally, the residents who require treatment will be referred to Kasr EL Ainy dental hospital to receive dental treatments.
- Being tested
- Teledentistry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeledentistryDiagnostic test
Teledentistry using mobile photographs
What is being measured
The primary outcome is the main question the study is designed to answer.
Dentition status
Feasibility of tele dentistry mobile photographic method to assess the dentition status of the elderly living in elderly homes will be measured by comparing the tele dentistry method with the direct oral examination .The scores of the World Health Organization (WHO) assessment forms of oral health will be used with the crowns.
Also, the dentures section will be used to record the presence or absence of partial or complete dentures in both jaws.
Measured: January- December 2023
Secondary outcomes (1)
Oral Mucosal lesions
Signs for Oral potentially malignant disorders OPMD visible in the photographic views and direct examination will be recorded in the section of the oral mucosal lesions in the assessment form .This will be performed by the direct examiners and the tele dentistry examiners to compare both methods of examination.
Measured: January- December 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2021
- Study start31 Jan 2023
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Screening for Elderly in Aged Care HomesStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mennatollah Nagy Sharkawy Ali Nada, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05101681
- Sponsor's protocol ID
- Teledentistry for Elderly
- Status last verified
- Sep 2023
- First submitted
- 29 Oct 2021
- Last updated
- 14 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Teledentistry Versus Direct Oral Examination of Elderly in Aged-Care Homes: A Pilot Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT05101681
- Acronym / sponsor ID
- Teledentistry for Elderly
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 31 Jan 2023 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 1 Nov 2021 (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.
The residents will receive oral health education, then three examiners ( licensed dentists ) will perform the direct oral examination of the participants. During the same visit, a dental student will take the intraoral photographs in the aged care home.
Later, three different blinded examiners (licensed dentists) will assess the intraoral photographs of the same group of participants. The participant's dentition will be examined using the scores developed by the World Health Organization (WHO) for oral health surveys. Also, the examiners will perform a visual inspection of the oral mucosa for any signs of oral potentially malignant disorders (OPMD), as the mortality of high-risk populations is proven to be reduced by visual oral cancer screening.
Finally, the residents who require treatment will be referred to Kasr EL Ainy dental hospital to receive dental treatments.
Detailed description
The residents will receive oral health education, by three examiners ( licensed dentists ) with a t least 5 years experience. Then the same examiner will perform the direct oral examination of the participants. They will fill the dentition status, denture status, oral lesions and intervention urgency section of the World Health Organization (WHO) form 2013 version.
During the same visit, a dental student will take the intraoral photographs in the aged care home. The photographs will include 5 views (upper occlusal, lower occlusal , frontal, right lateral and left lateral).
The photographs will be uploaded on one drive and later, three different blinded examiners (licensed dentists) will assess the intraoral photographs of the same group of participants. The participant's dentition will be examined using the scores developed by the World Health Organization (WHO) for oral health surveys. Also, the examiners will perform a visual inspection of the oral mucosa for any signs of oral potentially malignant disorders (OPMD), as the mortality of high-risk populations is proven to be reduced by visual oral cancer screening.
Finally, the residents who require treatment will be referred to Kasr EL Ainy dental hospital to receive dental treatments.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The participants are elderly living in aged care homes in Egypt who must be able to communicate with the examiner and must be able to give consent to participate in the study.
Key inclusion criteria (3 listed)
- Elderly living in aged care homes in Egypt
- Have the ability to communicate with the examiner
- Have the ability to give consent to participate in the study.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| TeledentistryTeledentistry using mobile photographs | Diagnostic test | – |
Primary outcome
Dentition status
Time frame: January- December 2023
Feasibility of tele dentistry mobile photographic method to assess the dentition status of the elderly living in elderly homes will be measured by comparing the tele dentistry method with the direct oral examination .The scores of the World Health Organization (WHO) assessment forms of oral health will be used with the crowns. Also, the dentures section will be used to record the presence or absence of partial or complete dentures in both jaws.
1 secondary outcome
Oral Mucosal lesions
Time frame: January- December 2023
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Screening for Elderly in Aged Care Homes, run by Cairo University at 2 sites 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 3 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mennatollah N. Sharkawy (+201278228778, MenaAllah.Nagy@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dentition status (time frame: January- December 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2023.