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

Sponsor

University of Chile (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05809817

Collaborator

(none)

Enrollment

Locations

21.1

Anticipated Duration (Months)

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus Periodontitis Diabetic Complication Dental Care	Procedure: Periodontal 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 Design

Study Type:

Observational

Anticipated Enrollment :

36 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	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).

Arm

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).

Outcome Measures

Primary Outcome Measures

Metabolic control [Baseline and 3 months after periodontal treatment]
Mean change from baseline HbA1c at 3 months after periodontal treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

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.
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).