NCT00873717

Brief Summary

Elderly persons in long-term facilities often have denutrition, associated with a bad oral and dental status. Yet, many elderly persons don't attend dentist care and when they have dental prothesis, do not often use them during meals. The impact of a rehabilitation of dental function on their nutritional status has not been proven. The objective of this study is to assess the impact of 2 strategies aimed to restore a good nutritional status, among patients with slight denutrition.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

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

January 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2009

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

July 26, 2012

Status Verified

April 1, 2009

Enrollment Period

3.5 years

First QC Date

April 1, 2009

Last Update Submit

July 25, 2012

Conditions

Nutrition Disorders

Keywords

elderlylong-term facilitiesnutritional status

Outcome Measures

Primary Outcomes (1)

  • comparison of GNRI mean-score between arms

    1 year

Study Arms (4)

Dentary

EXPERIMENTAL

Intervention: trimestrial follow-up of patients and counseling for appropriate care (if needed), in order to restore a minimum masticatory function, associated with particular focus on the realization of daily oral wash.

Other: Dentary

Nutrition

EXPERIMENTAL

control of the administration of dietary prescriptions, incitement to eat.

Other: Nutrition

Dentary + nutrition

EXPERIMENTAL

cleaning-up of oral cavity, with trimestrial dental and oral check-up with counseling for appropriate care (if needed) associated with control of the administration of dietary prescriptions, incitement to eat.

Other: Dentary + Nutrition

Control

NO INTERVENTION

usual care

Interventions

DentaryOTHER

cleaning-up of oral cavity, with trimestrial dental and oral check-up with counseling for appropriate care (if needed).

Dentary
NutritionOTHER

control of the administration of dietary prescriptions, incitement to eat.

Nutrition
Dentary + NutritionOTHER

trimestrial follow-up of patients and counseling for appropriate care (if needed), in order to restore a minimum masticatory function, associated with particular focus on the realization of daily oral wash. associated with control of the administration of dietary prescriptions, incitement to eat.

Also known as: Dentary and Nutrition
Dentary + nutrition

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Geriatric Nutritional Risk Index = 83.5 to 97.5; minimum age of 70 years old; living in long-term facilities; more than 6 months of anticipated length of stay

You may not qualify if:

  • refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Centre gérontologie Les Abondances

Boulogne-Billancourt, Île-de-France Region, 92100, France

Location

Institut ROGUET

Clichy, Île-de-France Region, 92, France

Location

AP-HP, Louis Mourier Hospital

Colombes, Île-de-France Region, 92700, France

Location

Hôpital Bretonneau

Paris, Île-de-France Region, 75018, France

Location

Hôpital de Puteaux

Puteaux, Île-de-France Region, 92, France

Location

AP-HP, Hôpital René Muret-Bigottini

Sevran, Île-de-France Region, 93, France

Location

MeSH Terms

Conditions

Nutrition Disorders

Interventions

Nutritional Status

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation Characteristics

Study Officials

  • Philippe CHARRU, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

  • Marysette FOLLIGUET, DDS

    Assistance Publique - Hôpitaux de Paris

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2009

First Posted

April 2, 2009

Study Start

January 1, 2009

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

July 26, 2012

Record last verified: 2009-04

Locations

FR(6)