Oral Health and Fundamental of Care Program (OHFCP2)

January 8, 2025 updated by: Alberto Dal Molin

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

  1. Baseline Evaluation (T0): Oral health assessment using OHAT and per standard protocol upon admission, intermediate days, and discharge.

  2. Training Program: Implementation of RNAO guidelines in two stages:

    Healthcare Staff Education Clinical workflow restructuring.

  3. 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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Novara, Italy, 28100
        • AOU Maggiore della Carità

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Pre-intervention group
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.
Active Comparator: OHFCP2
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.
Other: OHFCP2
The proposed intervention consists of a two-phase approach for implementing guidelines and evidence-based recommendations: educating healthcare professionals and enhancing clinical activity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
T0= ADMISSION; T5= DAY-5 (and every 5-days until discharge); T=100 (discharge)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alberto Dal Molin

Collaborators

Azienda Ospedaliero Universitaria Maggiore della Carita

Investigators

  • Principal Investigator: Chiara Gallione, PhD, MSN, RN, AOU Maggiore della Carità di Novara
  • Study Chair: Cristian Vairo, PhD st, MSN, RN, AOU Maggiore della Carità di Novara

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 16, 2023

Primary Completion (Actual)

December 11, 2023

Study Completion (Actual)

July 9, 2024

Study Registration Dates

First Submitted

December 24, 2024

First Submitted That Met QC Criteria

December 24, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 8, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CE078/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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