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Evaluation of Efficacy of Coconut Oil Mouth Care for Non-autonomous Hospitalised Elderly People. (COCO-CARE)

U

University of Limoges (UL)

Status

Not yet enrolling

Conditions

Geriatrics
Oral Health Care

Treatments

Procedure: Coconut oil mouth care
Procedure: Glycerin mouthwashes

Study type

Interventional

Funder types

Other

Identifiers

NCT07406425
87RI24_0064 (COCO-CARE)

Details and patient eligibility

About

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.

Enrollment

94 estimated patients

Sex

All

Ages

75+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

94 participants in 2 patient groups

Coconut oil mouth care
Experimental group
Description:
Daily oral care is done with coconut oil throughout the patient's hospitalization
Treatment:
Procedure: Coconut oil mouth care
Glycerin mouthwashes
Active Comparator group
Description:
Daily oral care is performed with glycerin sticks as in current practice.
Treatment:
Procedure: Glycerin mouthwashes

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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