Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05809817 |
| Other study ID # |
FONIS SAI0060 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2023 |
| Est. completion date |
December 2024 |
Study information
| Verified date |
March 2023 |
| Source |
University of Chile |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
