Evaluation of Efficacy of Coconut Oil Mouth Care for Non-autonomous Hospitalised Elderly People.

N/ANot Yet RecruitingNCT07406425

University Hospital, Limoges94 enrolled

Overview

This is a prospective, longitudinal, randomised, open-label, multicentric, interventional, comparative superiority study. The main objective is to demonstrate the superiority of oral care with coconut oil on the oral status of elderly people hospitalised in geriatrics, versus oral care with glycerol sticks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Geriatrics Oral Health Care

Interventions

Coconut oil mouth carePROCEDURE

Daily oral care is done with coconut oil throughout the patient's hospitalization

Glycerin mouthwashesPROCEDURE

Daily oral care is performed with glycerin sticks as in current practice.

Eligibility

Sex: ALLMin age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients aged 75 and over * Patients hospitalised in geriatric medicine and geriatric SMR departments * Patients able to open their mouths for treatment * Patients not able to carry out their oral hygiene on their own * Patients who have given their written consent (consent of the patient or patient consent accompanied by the designated representative if the patient is unable to give written consent) Exclusion Criteria: * Patients with a known allergy to coconut * Patients requiring medicated mouth care as prescribed by a doctor * Patients under guardianship, tutorship or curatorship * Confused patients who have had medically diagnosed dehydration for less than 48 hours * Patients with swallowing difficulties * Patients in the terminal phase of end of life Secondary exclusion criteria: * Patients leaving the department between D1 and D8 (whatever the reason for discharge, and including in the event of death) * Patients whose condition progresses towards a terminal phase of the end of life between D1 and D8 * Patients experiencing an allergic reaction to Coconut Oil during the study * Patients who may present with dehydration during the study

Locations (2)

CH de Brive

Brive-la-Gaillarde, France

CHU Limoges

Limoges, France

Outcomes

Primary Outcomes

Revised Oral Assement Guide (ROAG) between Day 1 and Day 8

Change in total score between Day 1 (D1) and Day 8 (D8) on the Revised Oral Assessment Guide (ROAG), translated and validated in French. The scale assesses 8 indicators (voice, swallowing, lips, tongue,saliva, mucous membranes, gums and teeth) according to 3 levels. The result gives a total score out of 24 points

Time frame: From Day 1 to Day 8

Secondary Outcomes

Weekly ROAG scores (Revised Oral Assment Guide)

Weekly ROAG scores (overall score and score per indicator) for all participants included until discharge (an assessment will also be carried out at discharge).

Time frame: Every week from the date of inclusion until the date of discharge, on average over 37 days.

ROAG betwen Day 1 (D1) and Day 8 (D8) for patients with "palliative care" status

Changes in the ROAG overall score between D1 and D8, translated and validated in French. The degree of dependence is assessed using the KATZ scale (dependence group) at inclusion.

Time frame: from Day 1 to Day 8

Number of oral care stopped

Number of patients who stopped the oral care initially proposed and reasons for discontinuing oral care, evaluated at the end of the study

Time frame: At the end of the study, on average of 37 days.

Data from ClinicalTrials.gov

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