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Oral HealthPAQUIDENT25NCT04065828

Oral Status and Care Needs of People Aged 90 and Over

An observational study of Oral Health and Morbidity, run by University Hospital, Bordeaux.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will help describe the state of oral health of very old people (over 90). Read more about this study

Who is it for?
Ages 90 to 100 years
Conditions the study is for
Oral Health, Morbidity
How many people
180 participants
Where
No sites listed yet
Study dates
11 Feb 2014to 5 Dec 2014
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 90 to 100 years
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: This is an ancillary study of the PAQUID cohort, of a cross-sectional nature, descriptive in a representative sample of very elderly people (≥90 years) in the Gironde and Dordogne, monocentric, with home collection.

Who may be able to join

  • Patients over 90 years old
  • Follow-up in 2013-2014 as part of the PAQUID cohort
  • Participation Agreement

Who cannot join

  • Inability to give informed consent and refusal of legal guardian.

About this study

Official title: Oral Status and Care Needs of People Aged 90 and Over in Gironde and Dordogne

This study will help describe the state of oral health of very old people (over 90).

Read the detailed description

In 2011, according to the French National Institute for Statistics and Economic Research, people aged 85 and over accounted for about 3% of the total population. This proportion will increase sharply due to longer life expectancy on the baby boom generation and is expected to reach 7.5% of the total population in 2050.

This very old population has specific health, related to the presence of co-morbidities and co-medications, but also to a frequent state of dependence.

These general health problems and their treatment can create or accentuate oral problems or complicate their management. Thus, very old people are more likely to have some oral diseases although there is no epidemiological data in France. Conversely, oral problems can have repercussions in terms of quality of life, social relations and nutrition, and are factors of risk or aggravating actual or potential systemic disorders.

This very elderly population is therefore likely to present new challenges of dental care that it is important to document.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. State of the mouth and teeth

    Number of decayed, absent and closed teeth

    Measured: Inclusion visit

  2. Masticatory ability

    Number of functional units

    Measured: Inclusion visit

  3. Root caries index

    Root caries index (RCI) - RCI is based on the requirement that gingival recession must occur before root caries surface lesion begin, therefore only teeth with gum recession are examined.

    • 4 surfaces of root are examined (mesial, distal, lingual, and buccal or labial)
    • A judgment of no gum recession is made if CEJ (cement enamel junction) cannot be visualized.

    The root caries index is calculated for an individual using the formula

    • RCI= (R-D) +(R-F) x 100 (R-D) +(R-F) +(R-N) R-N =Recession present surface normal or sound R-D =Recession present with decay root surface R-F= Recession present with a filled root surface.

    Measured: Inclusion visit

  4. Hygiene index

    Hygiene index (OHI-S, Simplified Oral Hygiene Index ; from 0 to 3)

    Measured: Inclusion visit

  5. Oral pain

    Presence of oral pain yes/no

    Measured: Inclusion visit

  6. Oral lesions

    Presence and nature of oral lesions according to the International Classification of Diseases applied to odontology and stomatology of the World Health Organization

    Measured: Inclusion visit

  7. Hyposalivation / xerostomia

    Presence of hyposalivation / xerostomia (Xerostomia Inventory, XI, 11 items questionary)

    Measured: Inclusion visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2019
  2. Study start11 Feb 2014
  3. Primary completion5 Dec 2014
  4. Study completion5 Dec 2014

Resources

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
Cohort
Time perspective
Prospective
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04065828
Sponsor's protocol ID
CHU BX 2013/04
Acronym
PAQUIDENT25
Status last verified
Jun 2025
First submitted
12 Aug 2019
Last updated
5 Jun 2025
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Khoury C, Samot J, Helmer C, Rosa RW, Georget A, Dartigues JF, Arrive E. The association between oral health and nutritional status in older adults: a cross-sectional study. BMC Geriatr. 2022 Jun 10;22(1):499. doi: 10.1186/s12877-022-03133-0.

    PubMed 35689206

  • Rosa RW, Samot J, Helmer C, Pourtau G, Dupuis V, Fricain JC, Georget A, Dartigues JF, Arrive E. Important oral care needs of older French people: A cross-sectional study. Rev Epidemiol Sante Publique. 2020 Apr;68(2):83-90. doi: 10.1016/j.respe.2020.01.135. Epub 2020 Feb 25.

    PubMed 32111348

Questions about this trial

What is this clinical trial studying?

An observational study of Oral Health and Morbidity, run by University Hospital, Bordeaux.

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 1 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: finished, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

State of the mouth and teeth (time frame: Inclusion visit). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04065828, which also lists 2 linked publications.

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 5 Jun 2025.

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