Exploring Adherence and Knowledge Among Diabetic Individuals in Periodontal Care

March 6, 2024 updated by: Karim Gariani

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Not Applicable

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:

  • Type 1 or type 2 diabetes

Exclusion Criteria:

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

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: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: dental visit invited
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 based on dental expertise
Experimental: dental visit recommended based on dental expertise
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
dental visit based on dental expertise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adherence of diabetic patients to periodontal
Time Frame: 1 month

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
calculate the prevalence of periodontitis
Time Frame: 1 month
Secondary endpoints are to calculate the prevalence of periodontitis and the accordance in diagnosis between the photo and the clinical examination of the patient.
1 month

Collaborators and Investigators

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

Sponsor

Karim Gariani

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 (Estimated)

March 1, 2024

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

February 28, 2024

First Submitted That Met QC Criteria

March 6, 2024

First Posted (Actual)

March 12, 2024

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-00124

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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