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Sponsored by: |
Assistance Publique - Hôpitaux de Paris |
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Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00873717 |
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 stratégies aimed to restore a good nutritional status, among patients with slight denutrition.
Condition | Intervention |
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Nutrition Disorders |
Other: Dentary Other: Nutrition Other: Dentary + Nutrition |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study |
Official Title: | Improvement of Nutritional Status in Elderly Residents of Long-Term Facilities: Impact of Two Strategies (Oral Care and Dietary Control) |
Estimated Enrollment: | 160 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Dentaire: 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.
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Other: Dentary
cleaning-up of oral cavity, with trimestrial dental and oral check-up with counseling for appropriate care (if needed).
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Nutrition: Experimental
control of the administration of dietary prescriptions, incitement to eat.
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Other: Nutrition
control of the administration of dietary prescriptions, incitement to eat.
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Both: 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.
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Other: Dentary + Nutrition
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.
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Control: No Intervention
usual care
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Two interventions are evaluated during a 1 year study period, with a 4 arms factorial design.
The "Dentary" intervention implies a 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.
The "Nutrition" intervention consists in 1) comparing the meals and oral supplements administered with the dietary prescriptions and 2) Incite patients to eat.
Ages Eligible for Study: | 70 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Laurence SALOMON, MD, PhD | 0033147606727 | laurence.salomon@lmr.aphp.fr |
Contact: Lucia Lopes | 0033140676529 | lucia.lopes@lmr.aphp.fr |
France, Ile de France | |
AP-HP, Louis Mourier Hospital | Recruiting |
Colombes, Ile de France, France, 92700 | |
Contact: Philippe Charru philippe.charru@lmr.aphp.fr | |
Sub-Investigator: Agnès Bodineau, DDS | |
Hôpital de Puteaux | Recruiting |
Puteaux, Ile de France, France, 92 | |
Contact: Arash MAJDLESSI, MD amadjlessi@ch-puteaux.fr | |
Sub-Investigator: Agnès Bodineau, DDS | |
Institut ROGUET | Not yet recruiting |
Clichy, Ile de France, France, 92 | |
Contact: Philippe EISCHEN philippe.eischen@fondation-roguet.fr | |
Sub-Investigator: Agnès Bodineau, DDS | |
AP-HP, Hôpital René Muret-Bigottini | Not yet recruiting |
Sevran, Ile de France, France, 93 | |
Contact: Henri-Pierre Cornu, MD hp.cornu@rmb.aphp.fr | |
Sub-Investigator: Rafik Allal, DDS |
Principal Investigator: | Philippe CHARRU, MD | Assistance Publique - Hôpitaux de Paris |
Study Chair: | Marysette FOLLIGUET, DDS | Assistance Publique - Hôpitaux de Paris |
Responsible Party: | Department Clinical Research of Developpement ( Aurélie Guimfack ) |
Study ID Numbers: | AOM07055, K070103, 2008-A00039-46 |
Study First Received: | April 1, 2009 |
Last Updated: | April 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00873717 History of Changes |
Health Authority: | France: Ministry of Health |
elderly long-term facilities nutritional status |
Nutrition Disorders |
Nutrition Disorders |