Evaluation of Efficacy of Coconut Oil Mouth Care for Non-autonomous Hospitalised Elderly People.
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age75+
SponsorUniversity Hospital, Limoges
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Coconut oil mouth care
Procedure/SurgeryDaily oral care is done with coconut oil throughout the patient's hospitalization
Glycerin mouthwashes
Procedure/SurgeryDaily oral care is performed with glycerin sticks as in current practice.
Treatment groups
94 Participants
are divided into 2 treatment groupsGroup A: Coconut oil mouth careExperimental treatment 1 intervention
Group B: Glycerin mouthwashesActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 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 8Secondary outcomes
1
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.2
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 in French. The degree of dependence is assessed using the KATZ scale (dependence group) at inclusion.
Time frame
from Day 1 to Day 83
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.Sponsors and contacts
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Source ClinicalTrials.gov
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