NCT06755411: OHFCP2

Oral Health and Fundamental of Care Program

Completed NA Last updated 10 January 2025

What this trial tests

NA trial testing OHFCP2 in Oral Hygiene, Oral Health in 60 participants. Completed in 9 July 2024.

Timeline

16 May 2023

Primary endpoint
11 December 2023

9 July 2024

Quick facts

Lead sponsor	Alberto Dal Molin
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	screening
Enrollment	60
Start date	16 May 2023
Primary completion	11 December 2023
Estimated completion	9 July 2024
Sites	1 location across Italy

Drugs / interventions tested

• OHFCP2

Conditions studied

• Oral Hygiene, Oral Health — all drugs for Oral Hygiene, Oral Health →
• Oral Cavity — all drugs for Oral Cavity →
• Nursing Care — all drugs for Nursing Care →
• Nursing Education — all drugs for Nursing Education →

Sponsor

Alberto Dal Molin

Who can join

18 and older, any sex, with Oral Hygiene, Oral Health or Oral Cavity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.