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

March 19, 2025 updated by: MELISA VERA, University of Chile

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Chile
    • Providencia
      • Santiago de Chile, Providencia, Chile

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c (The glycated hemoglobin)
Time Frame: 13 months

The glycated hemoglobin (HbA1c) is a blood test that measures the average blood glucose level over the past two to three months, expressed as a percentage. It is used to diagnose diabetes and prediabetes, and to monitor diabetes treatment.

A higher percentage indicates poorer glycemic control. The value will be measured at the beginning of periodontal treatment and during maintenance therapy at 3, 6, 9 and 12 months.
13 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient self-reported quality of life.
Time Frame: 13 months

Use of the OHIP-14 survey questionnaire that assesses people's quality of life in relation to their oral health.

It is administered through questions that quantify the impact of oral disorders. It is based on 7 dimensions: physical pain, functional limitation, psychological discomfort, physical disability, psychological disability, and social disability.

Scores range from 0 to 56 and are obtained by summing the ordinal values of the 14 items. Higher scores indicate a worse quality of life, and lower scores indicate a better quality of life.

The Spanish version has been validated in older adults in Chile. We will apply the survey at the beginning of study and 12 months later.
13 months
Probing deep in periodontal evaluation
Time Frame: 13 months

Probing depth is the distance between the gingival margin and the bottom of the periodontal pocket. It is measured in millimeters using a periodontal probe.

It is measured at six points on each tooth. The probe is inserted parallel to the root surface in the periodontal pocket. It is moved around the gingival margin. In healthy areas, probing depth should not exceed 3 mm. Depths greater than 3.9 mm may indicate periodontal disease. We will administer this assessment at entry into the study and at 3, 6, 9, and 12 months.
13 months
Clinical attachment loss in periodontal evaluation
Time Frame: 13 months

Clinical attachment loss is the difference between the position of the gum and the probing depth.

It is measured at six points on each tooth using a periodontal probe. It is measured in millimeters.

It is classified according to defined stages:

Stage 1: 1 to 2 millimeters Stage 2: 2 to 3 millimeters Stages 3 and 4: 5 millimeters or more The assessment is performed at admission, and at 3, 6, 9, and 12 months.
13 months
bleeding of probing in periodontal evaluation
Time Frame: 13 months

Bleeding on probing is a clinical parameter that indicates inflammation in the connective tissue of the gums.

It is performed with a standardized periodontal probe. It is measured at six sites per tooth. It is a dichotomous variable, considered positive if bleeding occurs, or negative if no bleeding occurs.

A value of less than 10% bleeding from all sites is considered periodontal stability.

It will be assessed at admission and at 3, 6, 9, and 12 months.
13 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chile

Investigators

  • Principal Investigator: Melisa Vera, Specialist in periodontics, University of Chile

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 22, 2023

Primary Completion (Estimated)

October 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

March 13, 2025

First Submitted That Met QC Criteria

March 19, 2025

First Posted (Estimated)

March 26, 2025

Study Record Updates

Last Update Posted (Estimated)

March 26, 2025

Last Update Submitted That Met QC Criteria

March 19, 2025

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023/12
  • Gianina Cánnepa SPCH (Other Identifier: Periodontics Society of Chile)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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