NCT06302855

Brief Summary

Objective(s) The primary objective is to evaluate the adherence of diabetic patients to periodontal care, accomplished either through oral communication (group A, control) or through a photograph of their smile, and focusing on their gum health evaluated by a periodontist (group B, test). Secondary objectives include assessing the prevalence of periodontal disease (PD) in this diabetic sample population and evaluating the presence of specific biomarkers related to it. The final objective is to assess the agreement between the diagnosis of periodontitis based on the photographs and the diagnosis given after the dental visit, based on the clinical examination. The aim is to determine if the photos could potentially serve as a reliable indicator for periodontal risk assessment.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
3mo left

Started Mar 2024

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Mar 2024Sep 2026

First Submitted

Initial submission to the registry

February 28, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

2 years

First QC Date

February 28, 2024

Last Update Submit

March 6, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • adherence of diabetic patients to periodontal

    The primary endpoint is to evaluate the adherence of diabetic patients to periodontal care either by informing them orally or after evaluation of their gum health by a periodontist based on a simple photo of their smile. .

    1 month

Secondary Outcomes (1)

  • calculate the prevalence of periodontitis

    1 month

Study Arms (2)

dental visit invited

ACTIVE COMPARATOR

Patients will only be invited or asked to schedule a complimentary periodontal check-up visit without any previous assessment.

Diagnostic Test: dental expertise

dental visit recommended based on dental expertise

EXPERIMENTAL

Patients' oral cavities will be photographed. Based on the remote assessment of periodontitis risk conducted by the same periodontist from the Division of Regenerative Dental Medicine and Periodontology at the University Clinic of Dental Medicine, patients will be invited or asked to schedule a complimentary periodontal check-up visit at the CUMD. The appointment will be arranged directly at the diabetologist's office.

Diagnostic Test: dental expertise

Interventions

dental expertiseDIAGNOSTIC_TEST

dental visit based on dental expertise

dental visit inviteddental visit recommended based on dental expertise

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 1 or type 2 diabetes

You may not qualify if:

  • last dental visit\<1 year
  • patient unable to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD/PhD Head of Diabetes Unit Geneva University Hospital Switzerland

Study Record Dates

First Submitted

February 28, 2024

First Posted

March 12, 2024

Study Start

March 1, 2024

Primary Completion

March 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

March 12, 2024

Record last verified: 2024-03