Effect of Periodontal Treatment on Metabolic Control in Patients with Type-2 Diabetes Mellitus Treated in the Cardiovascular Healt Program

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-22

Study Completion Date

2025-12-31

Brief Summary

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The objective of this clinical trial is to evaluate the effect of periodontal treatment on the reduction of glycated hemoglobin levels in adult patients with concurrent type 2 diabetes mellitus and periodontitis.

Non-surgical periodontal treatment and the application of a quality of life survey will be performed and then controls will be carried out for 1 year.

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Detailed Description

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The aim of this clinical trial is to evaluate the effect of periodontal treatment on the reduction of HbA1c levels in adult patients with type 2 diabetes mellitus who are users of the Cardiovascular Health Program and also to measure their quality of life by means of a survey OHIP-14sp.

Non-surgical periodontal treatment and subsequent follow-up of periodontal clinical parameters and HbA1c values at 3, 6, 9 and 12 months will be performed.

Conditions

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Periodontitis Chronic Generalized Moderate Periodontitis Periodontal Disease Diabetes Mellitus Type 2

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Longitudinal study of difference-in-difference

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients with periodontitis and Diabetes Mellitus type 2

There will be a group of patients to intervene, who present periodontitis and Diabetes Mellitus type 2.

Group Type EXPERIMENTAL

Non-surgical periodontal treatment, glycated hemoglobin measurement and application of OHIP-14SP survey.

Intervention Type PROCEDURE

Non-surgical periodontal treatment will be performed, with periodontal maintenance therapy at 3, 6, 9 and 12 months, with measurement of glycated hemoglobin at each time and application of the OHIP-14SP oral health-related quality of life survey.

Interventions

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Non-surgical periodontal treatment, glycated hemoglobin measurement and application of OHIP-14SP survey.

Non-surgical periodontal treatment will be performed, with periodontal maintenance therapy at 3, 6, 9 and 12 months, with measurement of glycated hemoglobin at each time and application of the OHIP-14SP oral health-related quality of life survey.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 1a. Patients enrolled in the PSCV with a diagnosis of type 2 diabetes mellitus and who, in turn, have a glycated hemoglobin ≥ 7% (during the last 6 months).
* 1b. Patients with a diagnosis of periodontitis (≥ 2 non-adjacent teeth with detectable clinical interproximal attachment loss or, attachment loss ≥ 3mm with depth to probing ≥ 3mm on free faces of ≥ 2 teeth, where the attachment loss was not attributed to non-periodontal causes (Papapanou et al., 2018)).

Exclusion Criteria

* 2a. Patients who have received periodontal treatment during the last year.
* 2b. Pregnancy/lactation, because they are under treatment under the Explicit Health Guarantee "Oral and Integral Health of Pregnant Women".
* 2c. Therapy with antibiotics and/or non-steroidal anti-inflammatory drugs (NSAIDs) in the last 6 months prior to the study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No