Type 2 Diabetes MellitusNCT05809817
Oral Health Policy for Patients With Type 2 Diabetes Mellitus in Chile: A Microsimulation Model Based on Real-world Data
An observational study of Type 2 Diabetes Mellitus and Periodontitis, run by University of Chile at 2 sites in Chile.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus, Periodontitis, Diabetic Complication
- What is being tested?
- Periodontal treatment
- Type of treatment
- Surgery or procedure
- How many people
- 135 participants
- Where
- 2 sitesChile
- Study dates
- 1 Mar 2023to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with T2DM under follow-up in the PSCV
Who may be able to join
- 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).
Who cannot join
- Patients with a history of periodontal treatment.
- Pregnant or breastfeeding.
- Time spent in PSCV<1year.
Trial locations and contacts
2 sites in 1 country.
Chile2 sites
CESFAM Puerto VARAS
Puerto Varas, De Los Rios
CEMO Villa Sur
Santiago, 8480437
About this study
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
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.
Read the 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.
- Being tested
- Periodontal treatment
- Keywords
- Periodontics, Periodontal Medicine, Type 2 Diabetes Mellitus, Non-surgical Periodontal Therapy, Diabetic complication, Cost-Effectiveness Analysis
- Medical subject headings
- Diabetes Mellitus, Type 2, Periodontitis, Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal treatmentProcedure or surgery
Scaling and root planing
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic control
Mean change from baseline HbA1c at 3 months after periodontal treatment
Measured: Baseline and 3 months after periodontal treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start1 Mar 2023
- Primary completionMay 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mauricio Baeza, DDS,MSc,PhD, Study chair, Department of Conservative Dentistry, Faculty of Dentistry, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05809817
- Sponsor's protocol ID
- FONIS SAI0060
- Status last verified
- Mar 2023
- First submitted
- 10 Mar 2023
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The datasets generated during and/or analysed during the study will be available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05809817
- Acronym / sponsor ID
- FONIS SAI0060
- Keywords
- Periodontics, Periodontal Medicine, Type 2 Diabetes Mellitus, Non-surgical Periodontal Therapy, Diabetic complication, Cost-Effectiveness Analysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 135 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 12 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention (Periodontal treatment) | – | Procedure: Periodontal treatmentPatients 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. |
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with T2DM under follow-up in the PSCV
Key inclusion criteria (2 listed)
Key exclusion criteria (3 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Periodontal treatmentScaling and root planing | Procedure or surgery | Intervention (Periodontal treatment) |
Primary outcome
Metabolic control
Time frame: Baseline and 3 months after periodontal treatment
Mean change from baseline HbA1c at 3 months after periodontal treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- Individual participant dataSharing planned: Undecided. The datasets generated during and/or analysed during the study will be available from the corresponding author on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mauricio Baeza, DDS,MSc,PhD study chair
Department of Conservative Dentistry, Faculty of Dentistry, University of Chile
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus and Periodontitis, run by University of Chile at 2 sites in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic control (time frame: Baseline and 3 months after periodontal treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2024.