Menu
Not yet recruiting NCT07406425

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

No phase Interventional Geriatrics Oral Health Care

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Coconut oil mouth care, Glycerin mouthwashes.
Who it may be relevant to
Registry conditions: Geriatrics, Oral Health Care. Basic parameters: from 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Interventions

  • Procedure Coconut oil mouth care
    Daily oral care is done with coconut oil throughout the patient's hospitalization
  • Procedure Glycerin mouthwashes
    Daily oral care is performed with glycerin sticks as in current practice.

Primary outcome measures

  • Revised Oral Assement Guide (ROAG) between Day 1 and Day 8 [Time frame: From Day 1 to Day 8]
Secondary outcome measures (3)
  • 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.]
  • ROAG betwen Day 1 (D1) and Day 8 (D8) for patients with "palliative care" status [Time frame: from Day 1 to Day 8]
  • Number of oral care stopped [Time frame: At the end of the study, on average of 37 days.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

France · 2 centers
  • CH de Brive — Brive-la-Gaillarde
  • CHU Limoges — Limoges

Identifiers

NCT: NCT07406425 · 87RI24_0064 (COCO-CARE)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗