Oral Hygiene, Oral HealthPOHIFNCT07063927
Personalized Oral Hygiene Instruction Form
A study testing personalized oral instruction form in people with Oral Hygiene, Oral Health and Plaque Score, run by University of Geneva, Switzerland at 2 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral Hygiene, Oral Health, Plaque Score, Dental Plaque Index
- What is being tested?
- personalized oral instruction form
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 31 May 2022to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Clinique universitaire de médecine dentaire
Geneva, Canton of Geneva, 1211
Maison de Vessy
Vessy, Canton of Geneva, 1234
About this study
Official title: The Impact of a Personalized Oral Health Instruction Form Health Indices in Institutionalized Older Adults: A Randomized, Controlled, Single-Blinded Clinical Trial.
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.
Read the detailed description
The study aims to test whether a newly developed tool can help caregivers improve the oral health indices of institutionalized residents.
Caregivers of the institution will be identified by the medicalized home and will be asked to answer a questionnaire pertaining to various aspects of oral health care. The questionnaire is divided into 5 themes, the first section will collect general information on the caregiver and will comprise 3 questions about age range, years of professional experience and current position. The investigators will not be able to identify the caregivers out of the 3 questions. The second theme will request information on the knowledge and clinical practices related to the oral care of dependent and independent in-residents. Caregivers will also rate the perceived importance of oral care in relation to general health on a Visual Analogue Scale (VAS) from 0 to 100. Other questions will inquire about tooth brushing, intraoral inspection, cleaning of prosthetic appliances and storage habits. The third theme consists of a closed check-list of instruments, asking if they were known to the caregivers and if they used it in their institutional setting. The fourth theme covers the caregivers' perception of oral care and potential barriers to its provision. The fifth and last theme related to the perceived barriers concerning institution logistics and resident-related factors. At the end of the fifth section, an open question will be added for a qualitative description of any additional barriers to oral care that were not covered by the previous questions.
The questionnaire will be filled in a focus group should the sanitary situation related to the pandemic permits; if necessary, the questionnaire can be administered online as well. The questionnaire will comprise 20 questions and one open ended question, and takes an average of 6-8 minutes to be completed. All caregivers in a unit will receive a theoretical oral health provision training, followed by a hands-on session. After the training, the caregivers will be asked to fill the same questionnaire and the answers/ scores will be compared before and after the training.
Resident living in an institution will be screened and included if fitting the inclusion and exclusion criteria. 46 participants will be recruited. After recruitment, all participants will receive an oral examination and an oral hygiene kit. The oral examination will record plaque index (PI) by O'Leary, denture cleanliness index (DCI) by Ambjornsen and tongue coating index (TCI) by Shimizu.
The participants will also be asked to fill a questionnaire about their own perception of their oral health related Quality of Life (General oral health assessment index, GOHAI). The oral examination will be conducted in the resident's room.
The investigators will then customize the POHIF for all participants. After the completion of all the examination in all recruited participants, participants then will be randomized into two groups. The randomization will be done in clusters according to the geographic location of the resident room so that bundles of rooms will be in one group and another bundle of rooms will be in another group. Investigators will ensure that the residents in the different units are not all dependent on care or independent and that they are representative of the institution population.
This bloc randomization will insure that participants that are in the same room belong to the same group. Randomization sequences will be obtained from www.randomizer.org. The sequences will be kept in sealed opaque envelopes.
The investigator that will conduct the first examination and elaborates the POIF will be blinded to the participant group allocation.
For participants in the intervention group, 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 (N.M). For dependent residents, the personalized oral instruction form will be handed to the caregivers along with the personalized oral hygiene kit.
In the control group, independent and dependent residents will receive a hygiene kit, independent resident will continue to conduct their own oral care as usual, and for dependent residents, caregivers will provide the oral care as usual.
The duration of the study will be 3 weeks from the day of provision of the oral hygiene kit and the start of the intervention for every cluster of participants.
After 3 weeks, all included residents will get a second oral examination by the same investigator who conducted the first one.
Oral health indices will be again recorded.
- Conditions
- Oral Hygiene, Oral Health, Plaque Score, Dental Plaque Index, Denture Hygiene, Tongue Coating Thickness
- Being tested
- personalized oral instruction form
- Keywords
- oral hygiene, oral health, elderly, denture plaque score, dental plaque score, Tongue coating, medicalized homes, nursing homes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
personalized oral instruction formProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: personalized oral instruction form |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 weeks
Secondary outcomes (2)
Denture cleanliness index modified (DCIM) by Ambjornsen
The present index was introduced to assess the location and amount of plaque in some areas of the fitting surfaces of complete maxillary dentures. Scores were recorded in five defined areas on the denture base. Four ranked scores were used:
0: No visible plaque or plaque visible only by scraping on the denture base with a blunt instrument
1: Moderate accumulation of visible plaque and abundance of plaque
Measured: 3 weeks
Tongue coating index (TCI) by Shimizu
It is a visual method to assess the tongue-coating status based on observation of the coated thickness according 3 scores:
Score 0: Tongue coating not visible Score 1: Tongue coating thin, papillae of tongue visible Score 2: Tongue coating very thick, papillae of tongue not visible
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start31 May 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Oral Hygiene, Oral HealthStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Geneva, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frauke Müller, University of Geneva, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07063927
- Sponsor's protocol ID
- 2022-00086
- Acronym
- POHIF
- Status last verified
- Jun 2023
- First submitted
- 2 Jul 2025
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be made available upon reasonable request
Publications
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.
PubMed 4500182Shimizu 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.
PubMed 17518979Ambjornsen 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.
PubMed 6958165Chebib 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.
PubMed 41214684
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Personalized Oral Health Instruction Form Health Indices in Institutionalized Older Adults: A Randomized, Controlled, Single-Blinded Clinical Trial.
- ClinicalTrials.gov ID
- NCT07063927
- Acronym / sponsor ID
- POHIF / 2022-00086
- Conditions
- Oral Hygiene, Oral Health, Plaque Score, Dental Plaque Index, Denture Hygiene, Tongue Coating Thickness
- Keywords
- oral hygiene, oral health, elderly, denture plaque score, dental plaque score, Tongue coating, medicalized homes, nursing homes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of Geneva, SwitzerlandUniversity, hospital or other
- Study start
- 31 May 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 14 Jul 2025 (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.
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.
Detailed description
The study aims to test whether a newly developed tool can help caregivers improve the oral health indices of institutionalized residents.
Caregivers of the institution will be identified by the medicalized home and will be asked to answer a questionnaire pertaining to various aspects of oral health care. The questionnaire is divided into 5 themes, the first section will collect general information on the caregiver and will comprise 3 questions about age range, years of professional experience and current position. The investigators will not be able to identify the caregivers out of the 3 questions. The second theme will request information on the knowledge and clinical practices related to the oral care of dependent and independent in-residents. Caregivers will also rate the perceived importance of oral care in relation to general health on a Visual Analogue Scale (VAS) from 0 to 100. Other questions will inquire about tooth brushing, intraoral inspection, cleaning of prosthetic appliances and storage habits. The third theme consists of a closed check-list of instruments, asking if they were known to the caregivers and if they used it in their institutional setting. The fourth theme covers the caregivers' perception of oral care and potential barriers to its provision. The fifth and last theme related to the perceived barriers concerning institution logistics and resident-related factors. At the end of the fifth section, an open question will be added for a qualitative description of any additional barriers to oral care that were not covered by the previous questions.
The questionnaire will be filled in a focus group should the sanitary situation related to the pandemic permits; if necessary, the questionnaire can be administered online as well. The questionnaire will comprise 20 questions and one open ended question, and takes an average of 6-8 minutes to be completed. All caregivers in a unit will receive a theoretical oral health provision training, followed by a hands-on session. After the training, the caregivers will be asked to fill the same questionnaire and the answers/ scores will be compared before and after the training.
Resident living in an institution will be screened and included if fitting the inclusion and exclusion criteria. 46 participants will be recruited. After recruitment, all participants will receive an oral examination and an oral hygiene kit. The oral examination will record plaque index (PI) by O'Leary, denture cleanliness index (DCI) by Ambjornsen and tongue coating index (TCI) by Shimizu.
The participants will also be asked to fill a questionnaire about their own perception of their oral health related Quality of Life (General oral health assessment index, GOHAI). The oral examination will be conducted in the resident's room.
The investigators will then customize the POHIF for all participants. After the completion of all the examination in all recruited participants, participants then will be randomized into two groups. The randomization will be done in clusters according to the geographic location of the resident room so that bundles of rooms will be in one group and another bundle of rooms will be in another group. Investigators will ensure that the residents in the different units are not all dependent on care or independent and that they are representative of the institution population.
This bloc randomization will insure that participants that are in the same room belong to the same group. Randomization sequences will be obtained from www.randomizer.org. The sequences will be kept in sealed opaque envelopes.
The investigator that will conduct the first examination and elaborates the POIF will be blinded to the participant group allocation.
For participants in the intervention group, 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 (N.M). For dependent residents, the personalized oral instruction form will be handed to the caregivers along with the personalized oral hygiene kit.
In the control group, independent and dependent residents will receive a hygiene kit, independent resident will continue to conduct their own oral care as usual, and for dependent residents, caregivers will provide the oral care as usual.
The duration of the study will be 3 weeks from the day of provision of the oral hygiene kit and the start of the intervention for every cluster of participants.
After 3 weeks, all included residents will get a second oral examination by the same investigator who conducted the first one.
Oral health indices will be again recorded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Procedure: personalized oral instruction formIn 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| personalized oral instruction formThe 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. | Procedure or surgery | intervention group |
Primary outcome
Plaque Index (PI) by O'Leary, Drake and Naylor
Time frame: 3 weeks
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).
2 secondary outcomes
Denture cleanliness index modified (DCIM) by Ambjornsen
Time frame: 3 weeks
Tongue coating index (TCI) by Shimizu
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Background: PubMed 4500182O'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.
- Background: PubMed 17518979Shimizu 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.
- Background: PubMed 6958165Ambjornsen 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.
- Derived from this study: PubMed 41214684Chebib 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.
- Individual participant dataSharing planned: Undecided. Data will be made available upon reasonable request
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing personalized oral instruction form in people with Oral Hygiene, Oral Health and Plaque Score, run by University of Geneva, Switzerland at 2 sites in Switzerland.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 14 Jul 2025. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque Index (PI) by O'Leary, Drake and Naylor (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07063927, which also lists 4 linked publications.
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 14 Jul 2025.