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Recruiting NCT06895980

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

No phase Interventional Periodontitis Chronic Generalized Moderate Periodontitis Periodontal Disease Diabetes Mellitus Type 2

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Non-surgical periodontal treatment, glycated hemoglobin measurement and application of OHIP-14SP survey..
Who it may be relevant to
Registry conditions: Periodontitis Chronic Generalized Moderate, Periodontitis, Periodontal Disease, Diabetes Mellitus Type 2. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Chile
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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.

Interventions

  • 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.

Primary outcome measures

  • HbA1c (The glycated hemoglobin) [Time frame: 13 months]
Secondary outcome measures (4)
  • Patient self-reported quality of life. [Time frame: 13 months]
  • Probing deep in periodontal evaluation [Time frame: 13 months]
  • Clinical attachment loss in periodontal evaluation [Time frame: 13 months]
  • bleeding of probing in periodontal evaluation [Time frame: 13 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Chile · 1 center
  • Universidad de Chile — Santiago

Publications

  • Baeza M, Morales A, Cisterna C, Cavalla F, Jara G, Isamitt Y, Pino P, Gamonal J. Effect of periodontal treatment in patients with periodontitis and diabetes: systematic review and meta-analysis. J Appl Oral Sci. 2020 Jan 10;28:e20190248. doi: 10.1590/1678-7757-2019-0248. eCollection 2020. PMID 31939522
  • Cobb CM. Clinical significance of non-surgical periodontal therapy: an evidence-based perspective of scaling and root planing. J Clin Periodontol. 2002 May;29 Suppl 2:6-16. PMID 12010523

Identifiers

NCT: NCT06895980 · 2023/12 · Gianina Cánnepa SPCH

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗