NCT04065828

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2014

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 11, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2014

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 22, 2019

Completed
Last Updated

June 5, 2025

Status Verified

June 1, 2025

Enrollment Period

10 months

First QC Date

August 12, 2019

Last Update Submit

June 4, 2025

Conditions

Outcome Measures

Primary Outcomes (7)

  • State of the mouth and teeth

    Number of decayed, absent and closed teeth

    Inclusion visit

  • Masticatory ability

    Number of functional units

    Inclusion visit

  • 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.

    Inclusion visit

  • Hygiene index

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

    Inclusion visit

  • Oral pain

    Presence of oral pain yes/no

    Inclusion visit

  • 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

    Inclusion visit

  • Hyposalivation / xerostomia

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

    Inclusion visit

Eligibility Criteria

Age90 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

  • 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.

Study Officials

  • Elise ARRIVE, Dr

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2019

First Posted

August 22, 2019

Study Start

February 11, 2014

Primary Completion

December 5, 2014

Study Completion

December 5, 2014

Last Updated

June 5, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share