Oral Health Policy for Patients With Type 2 Diabetes Mellitus in Chile: A Microsimulation Model Based on Real-world Data

March 6, 2024 updated by: University of Chile

Economic Evaluation of the Current Proposal and Different Decision-making Scenarios of Coverage Increases of an Oral Health Policy for Patients With Type 2 Diabetes Mellitus in Chile: A Microsimulation Model Based on Real-world Data

The goal of this study is to evaluate the cost-effectiveness of the current proposal and different decision-making scenarios of periodontal care coverage increases for patients with T2DM in Chile. The main objective of the clinical section of this study (effectiveness) aims to determine the effectiveness of periodontal care in patients with T2DM under follow-up in the Cardiovascular Health Program (Programa de Salud Cardiovascular, PSCV) of the in the CEMO Villa Sur of Pedro Aguirre Cerda and the CESFAM Antonio Varas of Puerto Montt.

A highly matched control group is proposed using Propensity Score Matching of PSCV patients with T2DM who have not received periodontal care. This would allow a better comparison of the individuals who will actually be treated against a counterfactual against of those with similar characteristics who did not receive periodontal intervention during the follow-up period of this first stage.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Introduction: Oral diseases and type 2 Diabetes Mellitus (T2DM) constitute an important public health problem in Chile, due to their high prevalence and economic and social impact. T2DM increases the risk of oral diseases such as periodontitis, and the latter worsens the metabolic control of T2DM, increasing the risk of macrovascular and microvascular complications. More than 10% of total health spending in Chile is allocated to the treatment of T2DM, especially for the management of its complications. The main T2DM control program in Chile is the Cardiovascular Health Program (PSCV) that treats more than 900,000 people with T2DM, however, its results are still insufficient. Although periodontal treatment improves the metabolic control of T2DM, the proposed goal of periodontal care coverage for patients with T2DM in the context of the PSCV is only 2%. Therefore, the decision to expand periodontal care coverage to efficiently improve the health status of these patients is crucial.

Objective: To evaluate the cost-effectiveness of the current proposal and different decision-making scenarios for increasing periodontal care coverage for patients with T2DM from the perspective of the public health system in Chile.

Methods: In the first stage, a prospective observational cohort study will be conducted at the CEMO Villa Sur in Pedro Aguirre Cerda and at the CESFAM Puerto Varas in the commune of Puerto Montt to estimate treatment costs and the effectiveness of periodontal care on glycated hemoglobin (HbA1c) levels in the context of PSCV (real-world data). The intervention cohort will consist of those patients with T2DM receiving periodontal care during 2023, while the comparison cohort will consist of those on the waiting list during the same period, matched 1:1 through Propensity Score Matching. In a second stage the costs and effects of each coverage alternative (2%, 20%, 40%, 60%, 80% and 100%) will be modeled using microsimulation techniques to estimate the projected impact over a lifetime horizon of HbA1c changes on the risk of complications, death and decreased quality of life. Costs for each clinical stage will be obtained from national GES (Explicit Health Guarantees) cost estimates, supplemented by other sources, and quality-adjusted life years will be used as a summary measure of effects. Costs and effects will be combined to estimate the incremental cost-effectiveness ratio (ICER). From the probabilistic sensitivity analysis, acceptability curves and frontiers and expected loss curves for the proposed courses of action will be estimated.

Study Type

Observational

Enrollment (Actual)

135

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

  • Chile
      • Santiago, Chile, 8480437
        • CEMO Villa Sur
    • De Los Rios
      • Puerto Varas, De Los Rios, Chile
        • CESFAM Puerto VARAS

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

Sampling Method

Non-Probability Sample

Study Population

Patients with T2DM under follow-up in the PSCV

Description

  • Inclusion criteria:

    1. Intervention: Patients with T2DM under follow-up in the PSCV who present records of HbA1c levels for the last three months prior to care and who receive complete periodontal treatment at the CEMO Villa Sur in the commune of Pedro Aguirre Cerda and at the CESFAM Puerto Varas in Puerto Montt under the PSCV will be selected.
    2. Control: A control cohort of patients with T2DM under follow-up in the PSCV will be determined, matching 1:1 through Propensity Score Matching according to baseline HbA1c levels and demographic baseline data (age and sex).

  • Exclusion criteria:

    1. Patients with a history of periodontal treatment.
    2. Pregnant or breastfeeding.
    3. Time spent in PSCV<1year.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Intervention (Periodontal treatment)
Patients with T2DM under follow-up in the PSCV will receive the usual periodontal therapy performed at the CEMO Villa Sur in the commune of Pedro Aguirre Cerda and at the CESFAM Puerto Varas in the context of PSCV. The care protocols and national evidence establish that the standard treatment of periodontitis consists of 4 or more sessions of scaling and root planing per sextant, depending on the severity of the disease.
Procedure: Periodontal treatment
Scaling and root planing
Control (Matched, non-active intervention)
Patients with T2DM under follow-up in the PSCV, with non-active control (withouth periodontal treatment) that will be matched in a ratio of 1:1 through Propensity Score Matching according to baseline HbA1c levels and demographic baseline data (age, sex).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metabolic control
Time Frame: Baseline and 3 months after periodontal treatment
Mean change from baseline HbA1c at 3 months after periodontal treatment
Baseline and 3 months after periodontal treatment

Collaborators and Investigators

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

Sponsor

University of Chile

Investigators

  • Study Chair: Mauricio Baeza, DDS,MSc,PhD, Department of Conservative Dentistry, Faculty of Dentistry, University of Chile

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)

March 1, 2023

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

March 10, 2023

First Submitted That Met QC Criteria

April 11, 2023

First Posted (Actual)

April 12, 2023

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FONIS SAI0060

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The datasets generated during and/or analysed during the study will be available from the corresponding author on reasonable request.

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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