CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
OHFCP2other
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06755411
NCT06755411N/ACompleted

Oral Health Promotion and Fundamental of Care: an Evidence-based Practice Educational Program

Alberto Dal Molin·interventional·Posted Jan 1, 2025·Updated Jan 10, 2025

In Brief

A clinical study evaluating OHFCP2 for Oral Hygiene, Oral Health and 3 related conditions. Completed, enrolled 60 participants across 1 site.

Detailed 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 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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly

Timeline

N/ACompletedFinished
202420252026
First PostedJan 1, 2025
Enrollment StartMay 16, 2023
Primary CompletionDec 11, 2023
Study CompletionJul 9, 2024
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 1.5 years ago

Interventions

OHFCP2other

The proposed intervention consists of a two-phase approach for implementing guidelines and evidence-based recommendations: educating healthcare professionals and enhancing clinical activity.