Oral Hygiene, Oral HealthOHFCP2NCT06755411
Oral Health and Fundamental of Care Program
A study testing OHFCP2 in people with Oral Hygiene, Oral Health and Oral Cavity, run by Alberto Dal Molin at 1 site in Italy.
Trial summary
Introduction: Oral health significantly impacts daily life, affecting communication, nutrition, emotional expression, self-esteem, and overall quality of life. Poor oral health is associated with conditions ranging from caries and periodontal disease to systemic issues such as diabetes, cardiovascular disorders, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Hygiene, Oral Health, Oral Cavity, Nursing Care
- What is being tested?
- OHFCP2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 16 May 2023to 9 Jul 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who met the requirements for the study should have been at least 18 years old, be admitted on a regular schedule, and be able to understand and give informed consent for the study. Patients assigned, even temporarily, to other inpatient wards were not eligible
- Only patients admitted to Internal General Medicine Ward at Maggiore della Carità Hospital, Novara, a 640-bed university hospital in northern Italy.
Who cannot join
- Patients unable to understand and consent, with critical conditions preventing oral cavity assessment (e.g., presence of non-removable non-invasive ventilatory support devices, transient disorientation, unwillingness to participate) were excluded. Patients had the right to withdraw their participation agreement at any point during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Health Promotion and Fundamental of Care: an Evidence-based Practice Educational Program
Introduction:
Oral health significantly impacts daily life, affecting communication, nutrition, emotional expression, self-esteem, and overall quality of life. Poor oral health is associated with conditions ranging from caries and periodontal disease to systemic issues such as diabetes, cardiovascular disorders, and increased mortality.
Read more
Background and Rationale:
Oral frailty, a concept originating in Japan in 2013, highlights the deterioration of oral function due to aging, potentially leading to malnutrition and systemic health impacts. The 2017 Global Burden of Disease Study emphasized oral health as an ongoing global challenge, identifying caries, severe periodontitis, and edentulism as prevalent issues. Preventable oral diseases contribute significantly to health disparities and systemic illnesses.
Aims:
Primary: To evaluate the impact of an educational intervention to implement evidence-based guidelines for oral health care in adult inpatients.
Secondary: To assess the concordance between different assessment tools and the improvement in knowledge of healthcare workers following training.
Methods:
Study Design: A before-and-after interventional study comparing pre- and post-educational intervention implementation cohorts.
Setting: Medical Department, Maggiore della Carità Hospital, Novara, Italy. Eligibility: Adults aged ≥18 years admitted for inpatient care who consent to participate.
Outcomes: Improvements in oral health outcomes as assessed by the OHAT tool and secondary metrics such as knowledge improvement in healthcare staff.
Intervention:
Training Sessions: Healthcare workers receive education on oral health guidelines, including practical and simulation-based activities.
Implementation: Adoption of evidence-based practices for oral health care.
Evaluation Phases:
Phase 1 (Baseline): Assessment of oral health in patients using OHAT and a structured evaluation protocol.
Phase 2 (Intervention): Educational sessions for healthcare workers. Phase 3 (Post-Implementation): Follow-up assessments using the same tools and methods as Phase 1.
Data Analysis:
Statistical methods include descriptive analysis, repeated measures models, and pre-post intervention comparisons. A significance level of 0.05 will be applied.
Sample Size:
A minimum of 48 participants (24 per cohort) is required, based on a hypothesised effect size of 0.5 with 80% power and a significance level of 0.05.
Ethical Considerations:
The protocol will be submitted for ethical approval. Data will be anonymised and handled per EU Regulation 2016/679 (GDPR).
Dissemination of Results:
Findings will be published in peer-reviewed journals and presented at conferences, maintaining participant confidentiality.
Read the detailed description
Background Oral health care encompasses all practices of education, motivation, prevention, assessment, and care delivery aimed at preventing and/or eliminating soft and hard tissue pathologies within the oral cavity or slowing their progression.
The literature highlights that oral hygiene needs are often not addressed at the same level as other health needs, and certain populations are at a higher risk of poor oral health compared to others.
Providing effective oral hygiene is essential to ensuring both local and systemic well-being. Oral health education aims to enhance knowledge and skills while promoting good practices to reduce morbidity associated with the oral cavity. Conversely, a lack of education and training strategies, as well as failure to implement preventive measures, inevitably leads to a progressive increase in oral health issues.
In the context of person-centered care, the standards derived from the delivery of fundamental care represent the baseline below which care quality should not fall. These standards are supported by robust evidence and defined through Clinical Practice Guidelines (CPGs).
Based on these considerations, a before-and-after study was designed to evaluate the effectiveness of an evidence-based guideline implementation program for oral health care and management, targeting nursing staff and healthcare assistants in the Internal Medicine Ward of the AOU Maggiore della Carità, Novara.
Global and Local Context The Global Burden of Disease Study 2017 provided a global perspective on the prevalence, incidence, and disability-adjusted life expectancy associated with oral health conditions, stratified by age, gender, and country from 1990 to 2017. The results demonstrate that oral health conditions and their management remain a significant global challenge.
Worldwide, oral health pathologies affect 3.5 billion individuals, including:
2.4 billion with untreated caries in permanent teeth (35% of the global population).
796 million with severe periodontitis. 532 million with untreated caries in primary teeth. 267 million with total edentulism. 139 million with other pathological conditions.
Oral cancer is among the top three cancers in the Pacific region of Asia. Most oral health conditions are preventable, can be intercepted early, and treated effectively. Notably, there is a well-established correlation between proper oral care and systemic conditions such as cardiovascular disorders, hypertension, stroke, diabetes, dementia, respiratory diseases, and increased mortality.
Assessment Tools for Oral Health Various tools are available to assess oral health status or estimate risks. The Registered Nurses' Association of Ontario (RNAO) recommends standardized approaches or validated tools for comprehensive assessment of oral and peri-oral structures, including evaluation of breath, hygiene, and pain.
The Oral Health Assessment Tool (OHAT), tested in various settings for adults, is practical, reliable, and quick for use by non-specialized healthcare staff. A validated Italian version is also available.
Study Objective This before-and-after study aims to assess the impact of implementing evidence-based guidelines for oral health care among adult patients admitted to a medical ward, focusing on changes in oral health-related outcomes.
Secondary Objectives:
Estimate concordance between adopted assessment tools. Evaluate changes in healthcare staff's knowledge of guidelines and best practices for oral health care.
Methodology Data collection will follow specific time points: upon admission, every five days, and at discharge. Assessments will include the OHAT scale and a protocol tailored for specialized oral health evaluations.
Primary Outcome: oral health improvement assessed using OHAT. Secondary Outcomes: Concordance between OHAT and standard protocol tailored for specialized oral health evaluations.
Knowledge improvement among staff pre- and post-training.
Intervention Phases
- Baseline Evaluation (T0): Oral health assessment using OHAT and per standard protocol upon admission, intermediate days, and discharge.
- Training Program: Implementation of RNAO guidelines in two stages: Healthcare Staff Education Clinical workflow restructuring.
- Post-Implementation Evaluation (T1): Reassessment using the same tools.
Sample Size and Statistical Analysis A minimum of 24 patients per group is required to detect an effect size of 0.5 with 80% power at a 0.05 significance level. Statistical analysis will compare changes in OHAT scores between groups using repeated measures models, chi-square tests, or non-parametric equivalents as appropriate.
Ethical Considerations The protocol will be submitted to the Institutional Ethics Committee for approval. Participants will provide informed consent, and data will be handled anonymously in compliance with GDPR regulations. Any protocol amendments will be reported promptly.
Conclusion This study seeks to provide evidence for the effectiveness of training programs and guideline implementation in improving oral health care practices, ultimately benefiting patient outcomes both locally and systemically.
- Being tested
- OHFCP2
- Keywords
- oral hygiene, oral health, fundamental of care, nursing care, nursing education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OHFCP2Other
The proposed intervention consists of a two-phase approach for implementing guidelines and evidence-based recommendations: educating healthcare professionals and enhancing clinical activity.
| Study group | Role | What they receive |
|---|---|---|
| Pre-intervention group | No intervention | The pre-intervention group was recruited between May and June 2023. At admission, every 5 days, and at discharge, an expert (dentists and/or dental hygienists) inspected the patient's oral cavity. The specialist personnel of the Department of Dentistry recorded data and observations on the proper documentation approved by the local ethics committee, combining the collection of socio-demographic data with the completion of the OHAT scale through its Italian validated version and the Internal Protocol of the Surgical Department of Dentistry (standard protocol). The expert panel assessed the selected patients during the following time frame: T0a (at admission); T0d (at discharge); T0i 1, 2, 3,… (intermediate) at five-day intervals until discharge, always at the same ideal time (about 9.00 am). Data collection required approximately 15 minutes per patient each time. |
| OHFCP2 | Active comparator | The intervention consists of a two-phase approach for implementing guidelines and evidence-based recommendations: educating healthcare professionals and enhancing clinical activity. A training course was developed for nurses and social health professionals. Lecture sessions on the most recent literature were held, as well as practical learning training sessions in high fidelity simulation, which included the assessment, preservation, and care of the oral and dental health.The intervention was administered to small groups consisting of 5-6 participants. An in-patient room situation with three possible scenarios and corresponding simulation manikins was set up: a person with a healthy oral cavity, a person with prosthesis, and an edentulous old person. After implementing the educational intervention, a new data collection phase began in the same hospital department during December replicating the same patient recruitment and evaluation process. Receives: Other: OHFCP2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of OHAT score related to educational intervention and timing T0, T5 and T100 (discharge)
The Oral Health Assessment Tool (OHAT) uses a Likert scale ranging from 0 (very healthy) to 2 (very unhealthy) for each item, with a total of 8 items assessed. The maximum score is 16, and higher scores indicate worse oral health conditions.
The OHAT average score differences in the pre-post-intervention phases, assessing if the educational intervention produces an effect of reducing the progression of oral cavity deterioration. Regarding the analysis of mouth conditions, any changes between admission and discharge were assessed with the OHAT tool. Because the data are correlated (evaluated at separate times) and classified into three groups (good, sufficient, and inadequate) Bhapkar's test was applied. The same assessment was done assuming that just the difference between T5 and T100 is reported, excluding the first evaluation upon admission, because it is influenced by oral hygiene practices carried out at home or in other setting.
Measured: T0= ADMISSION; T5= DAY-5 (and every 5-days until discharge); T=100 (discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start16 May 2023
- Primary completion11 Dec 2023
- Study completion9 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (45)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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Study design: the effectiveness of an evidence-based practice educational program to improve the quality of oral care has been evaluated in a before-and-after quasi-experimental study. The study adhered to The TREND statement guidelines, which provide a 22-item checklist designed to ensure consistent reporting of nonrandomized controlled trials. This statement, which is complementary to the widely recognized CONSORT statement for randomized controlled trials, was utilized to guide the study's methodology (Des Jarlais, Lyles, Crepaz, \& TREND Group, 2004).
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alberto Dal Molin
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliero Universitaria Maggiore della Carita
- Responsible party
- Sponsor-investigator, Alberto Dal Molin, Università degli Studi del Piemonte Orientale Amedeo Avogadro
- Investigators
- Chiara Gallione, PhD, MSN, RN, Principal investigator, AOU Maggiore della Carità di NovaraCristian Vairo, PhD st, MSN, RN, Study chair, AOU Maggiore della Carità di Novara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06755411
- Sponsor's protocol ID
- CE078/2023
- Acronym
- OHFCP2
- Status last verified
- Jan 2025
- First submitted
- 24 Dec 2024
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu, J.-H., Liu, M., Ho, M.-H., & Chang, C.-C. (2017). Oral Health of Older Adults in Long-Term Care Facilities: Effects of an Oral Care Program. J Oral Health Dent Care, 1(2), 1:008.
Wong FMF, Shie HWH, Kao E, Tsoi HM, Leung WK. Educational Programme on Knowledge, Attitudes, and Practice of Oral Care/Hygiene Provision by Healthcare Providers to Older Residents in Long-Term Care Institutions: A Case-Control Study. Geriatrics (Basel). 2024 Jan 29;9(1):16. doi: 10.3390/geriatrics9010016.
PubMed 38392103WHO. (2020). World Health Organization. Retrieved Nov. 2020, from Home/Health topics/Oral health: https://www.who.int/health-topics/oral-health/#tab=tab_1
Spoon D, Rietbergen T, Huis A, Heinen M, van Dijk M, van Bodegom-Vos L, Ista E. Implementation strategies used to implement nursing guidelines in daily practice: A systematic review. Int J Nurs Stud. 2020 Nov;111:103748. doi: 10.1016/j.ijnurstu.2020.103748. Epub 2020 Aug 18.
PubMed 32961463Sist L, Contini C, Bandini A, Bandini S, Massa L, Zanin R, Maricchio R, Gianesini G, Bassi E, Tartaglini D, Palese A, Ferraresi A. [MISSCARE Survey - Italian Version: findings from an Italian validation study]. Ig Sanita Pubbl. 2017 Jan-Feb;73(1):29-45. Italian.
PubMed 28428643Sasso L, Bagnasco A, Zanini M, Catania G, Aleo G, Santullo A, Spandonaro F, Icardi G, Watson R, Sermeus W. The general results of the RN4CAST survey in Italy. J Adv Nurs. 2017 Sep;73(9):2028-2030. doi: 10.1111/jan.13066. Epub 2016 Jul 26. No abstract available.
PubMed 27399267Sabbah W, Folayan MO, El Tantawi M. The Link between Oral and General Health. Int J Dent. 2019 May 29;2019:7862923. doi: 10.1155/2019/7862923. eCollection 2019. No abstract available.
PubMed 31275387Rootman I, Goodstadt M, Potvin L, Springett J. A framework for health promotion evaluation. WHO Reg Publ Eur Ser. 2001;(92):7-38. No abstract available.
PubMed 11729789RNAO. (2020, May). Registered Nurses Association of Ontario (RNAO). Retrieved 2023 Mar, from Best practice guidelines: https://rnao.ca/bpg/guidelines/oral-health-supporting-adults-who-require-assistance-second-edition
RNAO. (2020). Oral Health: Supporting Adults Who Require Assistance, Second Edition. In R. N. l'Ontario (Ed.), Best Practice Guideline. International Affairs and Best Practice Guideline (BPG) Oral Health .
RNAO. (2008). Oral Health: Nursing Assessment and Interventions. Nursing Best Practice Guideline. Toronto: Registered Nurses' Association of Ontario.
Razak PA, Richard KM, Thankachan RP, Hafiz KA, Kumar KN, Sameer KM. Geriatric oral health: a review article. J Int Oral Health. 2014 Nov-Dec;6(6):110-6.
PubMed 25628498Prendergast V, Kleiman C, King M. The Bedside Oral Exam and the Barrow Oral Care Protocol: translating evidence-based oral care into practice. Intensive Crit Care Nurs. 2013 Oct;29(5):282-90. doi: 10.1016/j.iccn.2013.04.001. Epub 2013 May 20.
PubMed 23702324Petersen PE, Baez RJ, Ogawa H. Global application of oral disease prevention and health promotion as measured 10 years after the 2007 World Health Assembly statement on oral health. Community Dent Oral Epidemiol. 2020 Aug;48(4):338-348. doi: 10.1111/cdoe.12538. Epub 2020 May 8.
PubMed 32383537Peres MA, Macpherson LMD, Weyant RJ, Daly B, Venturelli R, Mathur MR, Listl S, Celeste RK, Guarnizo-Herreno CC, Kearns C, Benzian H, Allison P, Watt RG. Oral diseases: a global public health challenge. Lancet. 2019 Jul 20;394(10194):249-260. doi: 10.1016/S0140-6736(19)31146-8.
PubMed 31327369
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Health Promotion and Fundamental of Care: an Evidence-based Practice Educational Program
- ClinicalTrials.gov ID
- NCT06755411
- Acronym / sponsor ID
- OHFCP2 / CE078/2023
- Keywords
- oral hygiene, oral health, fundamental of care, nursing care, nursing education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Alberto Dal MolinUniversity, hospital or other
- Collaborators
- Azienda Ospedaliero Universitaria Maggiore della Carita
- Study start
- 16 May 2023 (actual)
- Primary completion
- 11 Dec 2023 (actual)
- Study completion
- 9 Jul 2024 (actual)
- First posted
- 1 Jan 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.
Introduction:
Oral health significantly impacts daily life, affecting communication, nutrition, emotional expression, self-esteem, and overall quality of life. Poor oral health is associated with conditions ranging from caries and periodontal disease to systemic issues such as diabetes, cardiovascular disorders, and increased mortality.
Background and Rationale:
Oral frailty, a concept originating in Japan in 2013, highlights the deterioration of oral function due to aging, potentially leading to malnutrition and systemic health impacts. The 2017 Global Burden of Disease Study emphasized oral health as an ongoing global challenge, identifying caries, severe periodontitis, and edentulism as prevalent issues. Preventable oral diseases contribute significantly to health disparities and systemic illnesses.
Aims:
Primary: To evaluate the impact of an educational intervention to implement evidence-based guidelines for oral health care in adult inpatients.
Secondary: To assess the concordance between different assessment tools and the improvement in knowledge of healthcare workers following training.
Methods:
Study Design: A before-and-after interventional study comparing pre- and post-educational intervention implementation cohorts.
Setting: Medical Department, Maggiore della Carità Hospital, Novara, Italy. Eligibility: Adults aged ≥18 years admitted for inpatient care who consent to participate.
Outcomes: Improvements in oral health outcomes as assessed by the OHAT tool and secondary metrics such as knowledge improvement in healthcare staff.
Intervention:
Training Sessions: Healthcare workers receive education on oral health guidelines, including practical and simulation-based activities.
Implementation: Adoption of evidence-based practices for oral health care.
Evaluation Phases:
Phase 1 (Baseline): Assessment of oral health in patients using OHAT and a structured evaluation protocol.
Phase 2 (Intervention): Educational sessions for healthcare workers. Phase 3 (Post-Implementation): Follow-up assessments using the same tools and methods as Phase 1.
Data Analysis:
Statistical methods include descriptive analysis, repeated measures models, and pre-post intervention comparisons. A significance level of 0.05 will be applied.
Sample Size:
A minimum of 48 participants (24 per cohort) is required, based on a hypothesised effect size of 0.5 with 80% power and a significance level of 0.05.
Ethical Considerations:
The protocol will be submitted for ethical approval. Data will be anonymised and handled per EU Regulation 2016/679 (GDPR).
Dissemination of Results:
Findings will be published in peer-reviewed journals and presented at conferences, maintaining participant confidentiality.
Detailed description
Background Oral health care encompasses all practices of education, motivation, prevention, assessment, and care delivery aimed at preventing and/or eliminating soft and hard tissue pathologies within the oral cavity or slowing their progression.
The literature highlights that oral hygiene needs are often not addressed at the same level as other health needs, and certain populations are at a higher risk of poor oral health compared to others.
Providing effective oral hygiene is essential to ensuring both local and systemic well-being. Oral health education aims to enhance knowledge and skills while promoting good practices to reduce morbidity associated with the oral cavity. Conversely, a lack of education and training strategies, as well as failure to implement preventive measures, inevitably leads to a progressive increase in oral health issues.
In the context of person-centered care, the standards derived from the delivery of fundamental care represent the baseline below which care quality should not fall. These standards are supported by robust evidence and defined through Clinical Practice Guidelines (CPGs).
Based on these considerations, a before-and-after study was designed to evaluate the effectiveness of an evidence-based guideline implementation program for oral health care and management, targeting nursing staff and healthcare assistants in the Internal Medicine Ward of the AOU Maggiore della Carità, Novara.
Global and Local Context The Global Burden of Disease Study 2017 provided a global perspective on the prevalence, incidence, and disability-adjusted life expectancy associated with oral health conditions, stratified by age, gender, and country from 1990 to 2017. The results demonstrate that oral health conditions and their management remain a significant global challenge.
Worldwide, oral health pathologies affect 3.5 billion individuals, including:
2.4 billion with untreated caries in permanent teeth (35% of the global population).
796 million with severe periodontitis. 532 million with untreated caries in primary teeth. 267 million with total edentulism. 139 million with other pathological conditions.
Oral cancer is among the top three cancers in the Pacific region of Asia. Most oral health conditions are preventable, can be intercepted early, and treated effectively. Notably, there is a well-established correlation between proper oral care and systemic conditions such as cardiovascular disorders, hypertension, stroke, diabetes, dementia, respiratory diseases, and increased mortality.
Assessment Tools for Oral Health Various tools are available to assess oral health status or estimate risks. The Registered Nurses' Association of Ontario (RNAO) recommends standardized approaches or validated tools for comprehensive assessment of oral and peri-oral structures, including evaluation of breath, hygiene, and pain.
The Oral Health Assessment Tool (OHAT), tested in various settings for adults, is practical, reliable, and quick for use by non-specialized healthcare staff. A validated Italian version is also available.
Study Objective This before-and-after study aims to assess the impact of implementing evidence-based guidelines for oral health care among adult patients admitted to a medical ward, focusing on changes in oral health-related outcomes.
Secondary Objectives:
Estimate concordance between adopted assessment tools. Evaluate changes in healthcare staff's knowledge of guidelines and best practices for oral health care.
Methodology Data collection will follow specific time points: upon admission, every five days, and at discharge. Assessments will include the OHAT scale and a protocol tailored for specialized oral health evaluations.
Primary Outcome: oral health improvement assessed using OHAT. Secondary Outcomes: Concordance between OHAT and standard protocol tailored for specialized oral health evaluations.
Knowledge improvement among staff pre- and post-training.
Intervention Phases
- Baseline Evaluation (T0): Oral health assessment using OHAT and per standard protocol upon admission, intermediate days, and discharge.
- Training Program: Implementation of RNAO guidelines in two stages: Healthcare Staff Education Clinical workflow restructuring.
- Post-Implementation Evaluation (T1): Reassessment using the same tools.
Sample Size and Statistical Analysis A minimum of 24 patients per group is required to detect an effect size of 0.5 with 80% power at a 0.05 significance level. Statistical analysis will compare changes in OHAT scores between groups using repeated measures models, chi-square tests, or non-parametric equivalents as appropriate.
Ethical Considerations The protocol will be submitted to the Institutional Ethics Committee for approval. Participants will provide informed consent, and data will be handled anonymously in compliance with GDPR regulations. Any protocol amendments will be reported promptly.
Conclusion This study seeks to provide evidence for the effectiveness of training programs and guideline implementation in improving oral health care practices, ultimately benefiting patient outcomes both locally and systemically.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Study design: the effectiveness of an evidence-based practice educational program to improve the quality of oral care has been evaluated in a before-and-after quasi-experimental study. The study adhered to The TREND statement guidelines, which provide a 22-item checklist designed to ensure consistent reporting of nonrandomized controlled trials. This statement, which is complementary to the widely recognized CONSORT statement for randomized controlled trials, was utilized to guide the study's methodology (Des Jarlais, Lyles, Crepaz, \& TREND Group, 2004).
| Arm | Type | Receives |
|---|---|---|
| Pre-intervention group | No intervention | –The pre-intervention group was recruited between May and June 2023. At admission, every 5 days, and at discharge, an expert (dentists and/or dental hygienists) inspected the patient's oral cavity. The specialist personnel of the Department of Dentistry recorded data and observations on the proper documentation approved by the local ethics committee, combining the collection of socio-demographic data with the completion of the OHAT scale through its Italian validated version and the Internal Protocol of the Surgical Department of Dentistry (standard protocol). The expert panel assessed the selected patients during the following time frame: T0a (at admission); T0d (at discharge); T0i 1, 2, 3,… (intermediate) at five-day intervals until discharge, always at the same ideal time (about 9.00 am). Data collection required approximately 15 minutes per patient each time. |
| OHFCP2 | Active comparator | Other: OHFCP2The intervention consists of a two-phase approach for implementing guidelines and evidence-based recommendations: educating healthcare professionals and enhancing clinical activity. A training course was developed for nurses and social health professionals. Lecture sessions on the most recent literature were held, as well as practical learning training sessions in high fidelity simulation, which included the assessment, preservation, and care of the oral and dental health.The intervention was administered to small groups consisting of 5-6 participants. An in-patient room situation with three possible scenarios and corresponding simulation manikins was set up: a person with a healthy oral cavity, a person with prosthesis, and an edentulous old person. After implementing the educational intervention, a new data collection phase began in the same hospital department during December replicating the same patient recruitment and evaluation process. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who met the requirements for the study should have been at least 18 years old, be admitted on a regular schedule, and be able to understand and give informed consent for the study. Patients assigned, even temporarily, to other inpatient wards were not eligible
- Only patients admitted to Internal General Medicine Ward at Maggiore della Carità Hospital, Novara, a 640-bed university hospital in northern Italy.
Key exclusion criteria (1 listed)
- Patients unable to understand and consent, with critical conditions preventing oral cavity assessment (e.g., presence of non-removable non-invasive ventilatory support devices, transient disorientation, unwillingness to participate) were excluded. Patients had the right to withdraw their participation agreement at any point during the study.
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 |
|---|---|---|
| OHFCP2The proposed intervention consists of a two-phase approach for implementing guidelines and evidence-based recommendations: educating healthcare professionals and enhancing clinical activity. | Other | OHFCP2 |
Primary outcome
Variation of OHAT score related to educational intervention and timing T0, T5 and T100 (discharge)
Time frame: T0= ADMISSION; T5= DAY-5 (and every 5-days until discharge); T=100 (discharge)
The Oral Health Assessment Tool (OHAT) uses a Likert scale ranging from 0 (very healthy) to 2 (very unhealthy) for each item, with a total of 8 items assessed. The maximum score is 16, and higher scores indicate worse oral health conditions. The OHAT average score differences in the pre-post-intervention phases, assessing if the educational intervention produces an effect of reducing the progression of oral cavity deterioration. Regarding the analysis of mouth conditions, any changes between admission and discharge were assessed with the OHAT tool. Because the data are correlated (evaluated at separate times) and classified into three groups (good, sufficient, and inadequate) Bhapkar's test was applied. The same assessment was done assuming that just the difference between T5 and T100 is reported, excluding the first evaluation upon admission, because it is influenced by oral hygiene practices carried out at home or in other setting.
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 10 Jan 2025.
- BackgroundWu, J.-H., Liu, M., Ho, M.-H., & Chang, C.-C. (2017). Oral Health of Older Adults in Long-Term Care Facilities: Effects of an Oral Care Program. J Oral Health Dent Care, 1(2), 1:008.
- Background: PubMed 38392103Wong FMF, Shie HWH, Kao E, Tsoi HM, Leung WK. Educational Programme on Knowledge, Attitudes, and Practice of Oral Care/Hygiene Provision by Healthcare Providers to Older Residents in Long-Term Care Institutions: A Case-Control Study. Geriatrics (Basel). 2024 Jan 29;9(1):16. doi: 10.3390/geriatrics9010016.
- BackgroundWHO. (2020). World Health Organization. Retrieved Nov. 2020, from Home/Health topics/Oral health: https://www.who.int/health-topics/oral-health/#tab=tab_1
- Background: PubMed 32961463Spoon D, Rietbergen T, Huis A, Heinen M, van Dijk M, van Bodegom-Vos L, Ista E. Implementation strategies used to implement nursing guidelines in daily practice: A systematic review. Int J Nurs Stud. 2020 Nov;111:103748. doi: 10.1016/j.ijnurstu.2020.103748. Epub 2020 Aug 18.
- Background: PubMed 28428643Sist L, Contini C, Bandini A, Bandini S, Massa L, Zanin R, Maricchio R, Gianesini G, Bassi E, Tartaglini D, Palese A, Ferraresi A. [MISSCARE Survey - Italian Version: findings from an Italian validation study]. Ig Sanita Pubbl. 2017 Jan-Feb;73(1):29-45. Italian.
- Background: PubMed 27399267Sasso L, Bagnasco A, Zanini M, Catania G, Aleo G, Santullo A, Spandonaro F, Icardi G, Watson R, Sermeus W. The general results of the RN4CAST survey in Italy. J Adv Nurs. 2017 Sep;73(9):2028-2030. doi: 10.1111/jan.13066. Epub 2016 Jul 26. No abstract available.
- Background: PubMed 31275387Sabbah W, Folayan MO, El Tantawi M. The Link between Oral and General Health. Int J Dent. 2019 May 29;2019:7862923. doi: 10.1155/2019/7862923. eCollection 2019. No abstract available.
- Background: PubMed 11729789Rootman I, Goodstadt M, Potvin L, Springett J. A framework for health promotion evaluation. WHO Reg Publ Eur Ser. 2001;(92):7-38. No abstract available.
- BackgroundRNAO. (2020, May). Registered Nurses Association of Ontario (RNAO). Retrieved 2023 Mar, from Best practice guidelines: https://rnao.ca/bpg/guidelines/oral-health-supporting-adults-who-require-assistance-second-edition
- BackgroundRNAO. (2020). Oral Health: Supporting Adults Who Require Assistance, Second Edition. In R. N. l'Ontario (Ed.), Best Practice Guideline. International Affairs and Best Practice Guideline (BPG) Oral Health .
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- Oral health for adults in care homesLink provided by the sponsor.
- Oral health: local authorities and partnersLink provided by the sponsor.
- Oral health promotion in the communityLink provided by the sponsor.
- RNAO. Best practice guidelines: oral health supporting adultsLink provided by the sponsor.
- World Health Organization. Health topics/Oral healthLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Chiara Gallione, PhD, MSN, RN principal investigator
AOU Maggiore della Carità di Novara
Cristian Vairo, PhD st, MSN, RN study chair
AOU Maggiore della Carità di Novara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OHFCP2 in people with Oral Hygiene, Oral Health and Oral Cavity, run by Alberto Dal Molin at 1 site in Italy.
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 2 inclusion and 1 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 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
Variation of OHAT score related to educational intervention and timing T0, T5 and T100 (discharge) (time frame: T0= ADMISSION; T5= DAY-5 (and every 5-days until discharge); T=100 (discharge)). 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 NCT06755411, which also lists 45 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 10 Jan 2025.