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

NCT05809817 | Unknown

• 1 other identifier: FONIS SAI0060
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 2

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.

Conditions

Type 2 Diabetes Mellitus; Periodontitis; Diabetic Complication; Dental Care

Keywords

Periodontics; Periodontal Medicine; Type 2 Diabetes Mellitus; Non-surgical Periodontal Therapy; Diabetic complication; Cost-Effectiveness Analysis

Outcome Measures

Primary Outcomes (1)

• Metabolic control

  Mean change from baseline HbA1c at 3 months after periodontal treatment

  Baseline and 3 months after periodontal treatment

Study Arms (2)

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

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).

Interventions

Periodontal treatment PROCEDURE

Scaling and root planing

Intervention (Periodontal treatment)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with T2DM under follow-up in the PSCV

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• University of Chile: lead

Study Sites (2)

CESFAM Puerto VARAS

Puerto Varas, De Los Rios, Chile

Location

CEMO Villa Sur

Santiago, 8480437, Chile

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Periodontitis; Diabetes Complications

Interventions

Periodontal Index

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Health Surveys; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Dentistry; Periodontics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Dentistry

Study Officials

• Mauricio Baeza, DDS,MSc,PhD

  Department of Conservative Dentistry, Faculty of Dentistry, University of Chile

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2023
• First Posted: April 12, 2023
• Study Start: March 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 7, 2024

Record last verified: 2023-03

Locations

CL (2)