NCT07063927

Brief Summary

The objective of this study is to test a personalized oral hygiene instruction form (POHIF) elaborated after oral examination by a dentist and implemented by caregivers in nursing homes or similar medicalized homes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
1 country

2 active sites

Status
completed

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 Start

First participant enrolled

May 31, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 14, 2025

Completed
Last Updated

July 14, 2025

Status Verified

June 1, 2023

Enrollment Period

1.1 years

First QC Date

July 2, 2025

Last Update Submit

July 2, 2025

Conditions

Keywords

oral hygieneoral healthelderlydenture plaque scoredental plaque scoreTongue coatingmedicalized homesnursing homes

Outcome Measures

Primary Outcomes (1)

  • Plaque Index (PI) by O'Leary, Drake and Naylor

    It is a simple, non-invasive plaque index utilizing visualization of deposits to assess a person's oral hygiene effectiveness. Plaque index is then calculated using the following formula: (the number of surfaces with plaque) / the total number of available tooth surfaces) x 100. PI percentages range from a minimum of 0% (i.e. no plaque on any tooth surface) to maximum of 100% (i.e. all remaining surfaces are covered by plaque).

    3 weeks

Secondary Outcomes (2)

  • Denture cleanliness index modified (DCIM) by Ambjornsen

    3 weeks

  • Tongue coating index (TCI) by Shimizu

    3 weeks

Study Arms (2)

control group

NO INTERVENTION

In the control group, both independent and dependent residents will receive a hygiene kit and verbal instructions on how to conduct care by the hygienist. Independent residents will perform their oral care themselves. Caregivers will provide oral care to dependent residents.

intervention group

ACTIVE COMPARATOR

In the intervention group, the participants will receive and oral hygiene kit along with the verbal instruction and in addition to that, they will also receive the written personalized oral instruction form by the second investigator, it will be displayed in the personal bathroom of the residents. For dependent residents, the personalized oral instruction form will be handed to the caregivers along with the personalized oral hygiene kit.

Procedure: personalized oral instruction form

Interventions

The investigators will customize the POIF for participants. The POIF will be conceived to have a cover, and participants extraoral photos and intraoral photos will be covered when not conducting oral hygiene, the cover will ensure participants confidentiality. The personalized oral instruction form will be handed to the independent residents along with a hygiene kit comprising the necessary tools to conduct oral hygiene by the second investigator. For dependent residents, the personalized oral instruction form will be handed to the caregivers along with the personalized oral hygiene kit.

intervention group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Living in an institution for more than 6 weeks
  • Understand French
  • Give written informed consent or consent can be obtained from their next of kin or legal representative if necessary

You may not qualify if:

  • Non-cooperative participant
  • Having an infectious disease (according to a medical report)
  • Are undergoing currently dental treatment or need urgent treatment in next 3 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clinique universitaire de médecine dentaire

Geneva, Canton of Geneva, 1211, Switzerland

Location

Maison de Vessy

Vessy, Canton of Geneva, 1234, Switzerland

Location

Related Publications (4)

  • O'Leary TJ, Drake RB, Naylor JE. The plaque control record. J Periodontol. 1972 Jan;43(1):38. doi: 10.1902/jop.1972.43.1.38. No abstract available.

    PMID: 4500182BACKGROUND
  • Shimizu T, Ueda T, Sakurai K. New method for evaluation of tongue-coating status. J Oral Rehabil. 2007 Jun;34(6):442-7. doi: 10.1111/j.1365-2842.2007.01733.x.

    PMID: 17518979BACKGROUND
  • Ambjornsen E, Valderhaug J, Norheim PW, Floystrand F. Assessment of an additive index for plaque accumulation on complete maxillary dentures. Acta Odontol Scand. 1982;40(4):203-8. doi: 10.3109/00016358209019813.

    PMID: 6958165BACKGROUND
  • Chebib N, Rotzinger S, Maccarone-Ruetsche N, Sioufi R, Mojon P, Muller F. The impact of a personalized oral health instruction form on oral health indices in institutionalized older adults: a randomized, controlled, single-blinded clinical trial. BMC Oral Health. 2025 Nov 10;25(1):1769. doi: 10.1186/s12903-025-07102-y.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
The investigator conducting the oral examination was masked to the group allocation of the patient.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professeur

Study Record Dates

First Submitted

July 2, 2025

First Posted

July 14, 2025

Study Start

May 31, 2022

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

July 14, 2025

Record last verified: 2023-06

Locations