Evaluation of Efficacy of Coconut Oil Mouth Care for Non-autonomous Hospitalised Elderly People. (COCO-CARE)

February 5, 2026 updated by: University Hospital, Limoges

Evaluation of Efficacy of Coconut Oil Mouth Care for Non-autonomous Hospitalised Elderly People: a Multicentric Randomised Controlled Trial

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

94

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Coconut oil mouth care
Daily oral care is done with coconut oil throughout the patient's hospitalization
Procedure: Coconut oil mouth care
Daily oral care is done with coconut oil throughout the patient's hospitalization
Active Comparator: Glycerin mouthwashes
Daily oral care is performed with glycerin sticks as in current practice.
Procedure: Glycerin mouthwashes
Daily oral care is performed with glycerin sticks as in current practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Revised Oral Assement Guide (ROAG) between Day 1 and Day 8
Time Frame: From Day 1 to 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
From Day 1 to Day 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weekly ROAG scores (Revised Oral Assment Guide)
Time Frame: Every week from the date of inclusion until the date of discharge, on average over 37 days.
Weekly ROAG scores (overall score and score per indicator) for all participants included until discharge (an assessment will also be carried out at discharge).
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
Time Frame: from Day 1 to Day 8
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.
from Day 1 to Day 8
Number of oral care stopped
Time Frame: At the end of the study, on average of 37 days.
Number of patients who stopped the oral care initially proposed and reasons for discontinuing oral care, evaluated at the end of the study
At the end of the study, on average of 37 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Limoges

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 15, 2026

Primary Completion (Estimated)

October 15, 2026

Study Completion (Estimated)

October 15, 2026

Study Registration Dates

First Submitted

January 20, 2026

First Submitted That Met QC Criteria

February 5, 2026

First Posted (Actual)

February 12, 2026

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 87RI24_0064 (COCO-CARE)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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