GeriatricsCOCO-CARENCT07406425
Evaluation of Efficacy of Coconut Oil Mouth Care for Non-autonomous Hospitalised Elderly People.
A study testing Coconut oil mouth care and Glycerin mouthwashes in people with Geriatrics and Oral Health Care, run by University Hospital, Limoges at 2 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Geriatrics, Oral Health Care
- What is being tested?
- Coconut oil mouth care and Glycerin mouthwashes
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Oct 2026to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites
CH de Brive
Brive-la-Gaillarde, 19100
Michelle DELPY, 05 55 92 61 57 ext. +33, michelle.delpy@ch-brive.fr
Nathalie JAUBERT-SEGONG, 05 55 18 84 38 ext. +33, nathalie.jaubert-segond@ch-brive.fr
CHU Limoges
Limoges, 87042
Safirah AKOWANOU, 0555058755 ext. +33, safirah.akowanou@chu-limoges.fr
Anne-Sophie Queriaud, 05 55 05 67 46 ext. +33, annesophie.queriaud@chu-limoges.fr
About this study
Official title: 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.
- Conditions
- Geriatrics, Oral Health Care
- Being tested
- Coconut oil mouth care, Glycerin mouthwashes
- Keywords
- geriatrics, oral health care, elderly, coconut oil, palliative care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coconut oil mouth careProcedure or surgery
Daily oral care is done with coconut oil throughout the patient's hospitalization
Glycerin mouthwashesProcedure or surgery
Daily oral care is performed with glycerin sticks as in current practice.
| Study group | Role | What they receive |
|---|---|---|
| Coconut oil mouth care | Experimental | Daily oral care is done with coconut oil throughout the patient's hospitalization Receives: Procedure: Coconut oil mouth care |
| Glycerin mouthwashes | Active comparator | Daily oral care is performed with glycerin sticks as in current practice. Receives: Procedure: Glycerin mouthwashes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From Day 1 to Day 8
Secondary outcomes (3)
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).
Measured: 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 in French. The degree of dependence is assessed using the KATZ scale (dependence group) at inclusion.
Measured: 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
Measured: At the end of the study, on average of 37 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start1 Oct 2026 (estimated)
- Primary completion15 Apr 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GeriatricsStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07406425
- Sponsor's protocol ID
- 87RI24_0064 (COCO-CARE)
- Acronym
- COCO-CARE
- Status last verified
- Sep 2026
- First submitted
- 20 Jan 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy of Coconut Oil Mouth Care for Non-autonomous Hospitalised Elderly People: a Multicentric Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07406425
- Acronym / sponsor ID
- COCO-CARE / 87RI24_0064 (COCO-CARE)
- Conditions
- Geriatrics, Oral Health Care
- Keywords
- geriatrics, oral health care, elderly, coconut oil, palliative care
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 15 Apr 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coconut oil mouth care | Experimental | Procedure: Coconut oil mouth careDaily oral care is done with coconut oil throughout the patient's hospitalization |
| Glycerin mouthwashes | Active comparator | Procedure: Glycerin mouthwashesDaily oral care is performed with glycerin sticks as in current practice. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coconut oil mouth careDaily oral care is done with coconut oil throughout the patient's hospitalization | Procedure or surgery | Coconut oil mouth care |
| Glycerin mouthwashesDaily oral care is performed with glycerin sticks as in current practice. | Procedure or surgery | Glycerin mouthwashes |
Primary outcome
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 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
3 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coconut oil mouth care and Glycerin mouthwashes in people with Geriatrics and Oral Health Care, run by University Hospital, Limoges at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Revised Oral Assement Guide (ROAG) between Day 1 and Day 8 (time frame: From Day 1 to Day 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.