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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04065828
Other study ID # CHU BX 2013/04
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 11, 2014
Est. completion date December 5, 2014

Study information

Verified date August 2019
Source University Hospital, Bordeaux
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 180
Est. completion date December 5, 2014
Est. primary completion date December 5, 2014
Accepts healthy volunteers No
Gender All
Age group 90 Years and older
Eligibility Inclusion Criteria:

- Patients over 90 years old

- Follow-up in 2013-2014 as part of the PAQUID cohort

- Participation Agreement

Exclusion Criteria:

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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Bordeaux

Outcome

Type Measure Description Time frame Safety issue
Primary State of the mouth and teeth Number of decayed, absent and closed teeth Inclusion visit
Primary Masticatory ability Number of functional units Inclusion visit
Primary 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
Primary Hygiene index Hygiene index (OHI-S, Simplified Oral Hygiene Index ; from 0 to 3) Inclusion visit
Primary Oral pain Presence of oral pain yes/no Inclusion visit
Primary 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
Primary Hyposalivation / xerostomia Presence of hyposalivation / xerostomia (Xerostomia Inventory, XI, 11 items questionary) Inclusion visit
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