NCT07406425

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
Mar 2026Oct 2026

First Submitted

Initial submission to the registry

January 20, 2026

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 12, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

March 15, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2026

Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

7 months

First QC Date

January 20, 2026

Last Update Submit

February 5, 2026

Conditions

GeriatricsOral Health Care

Keywords

geriatricsoral health careelderlycoconut oilpalliative care

Outcome Measures

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 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 Outcomes (3)

  • Weekly ROAG scores (Revised Oral Assment Guide)

    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

    from Day 1 to Day 8

  • Number of oral care stopped

    At the end of the study, on average of 37 days.

Study Arms (2)

Coconut oil mouth care

EXPERIMENTAL

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

Procedure: Coconut oil mouth care

Glycerin mouthwashes

ACTIVE COMPARATOR

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

Procedure: Glycerin mouthwashes

Interventions

Coconut oil mouth carePROCEDURE

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

Coconut oil mouth care
Glycerin mouthwashesPROCEDURE

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

Glycerin mouthwashes

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CH de Brive

Brive-la-Gaillarde, 19100, France

Location

CHU Limoges

Limoges, 87042, France

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2026

First Posted

February 12, 2026

Study Start

March 15, 2026

Primary Completion (Estimated)

October 15, 2026

Study Completion (Estimated)

October 15, 2026

Last Updated

February 12, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)