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NCT Number: NCT07406425

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

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.

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Key information

Conditions

Geriatrics Oral Health Care

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH de Brive, Brive-la-Gaillarde, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coconut oil mouth care

Procedure

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

Glycerin mouthwashes

Procedure

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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).

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Official study title

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

Acronym: COCO-CARE

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 12, 2026
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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