Clinical trial NCT06895980: Effect of Periodontal Treatment on Metabolic Control in Patients with Type-2 Diabetes Mellitus Treated in the Cardiovascular Healt Program
Official title: Effect of Periodontal Treatment on Metabolic Control in Patients with Type-2 Diabetes Mellitus Treated in the Cardiovascular Healt Program
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Periodontitis Chronic Generalized Moderate
Periodontitis
Periodontal Disease
Diabetes Mellitus Type 2
Keywords: HbA1c
Periodontitis
Cardiovascular diseases
Diabetes mellitus
type 2 diabetes mellitus
scaling and root planing
Lead sponsor: University of Chile
Sponsor class: OTHER
First posted: 2025-03-26
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Longitudinal study of difference-in-difference
Primary purpose: TREATMENT

Brief summary: 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.

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.

Primary outcomes:
measure: HbA1c (The glycated hemoglobin)
timeFrame: 13 months
Secondary outcomes:
measure: Patient self-reported quality of life.
timeFrame: 13 months
measure: Probing deep in periodontal evaluation
timeFrame: 13 months
measure: Clinical attachment loss in periodontal evaluation
timeFrame: 13 months
measure: bleeding of probing in periodontal evaluation
timeFrame: 13 months
Other outcomes:
Locations:
city: Santiago de Chile
country: Chile
facility: Universidad de Chile
state: Providencia
Study officials:
affiliation: University of Chile
name: Melisa Vera, Specialist in periodontics
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.