Effect of Periodontal Treatment on Metabolic Control in Patients with Type-2 Diabetes Mellitus Treated in the Cardiovascular Healt Program (T2D)

University of Chile

Status: Enrolling

Conditions: Periodontitis; Periodontitis Chronic Generalized Moderate; Diabetes Mellitus Type 2; Periodontal Disease

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06895980

2023/12

Gianina Cánnepa SPCH (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Patients with periodontitis and Diabetes Mellitus type 2

Experimental group

Description:

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

Treatment:

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