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

NCT06895980 | Recruiting DMC

• 2 other identifiers: 2023/12Gianina Cánnepa SPCH
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• HbA1c (The glycated hemoglobin)

  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 Outcomes (4)

• Patient self-reported quality of life.

  13 months

• Probing deep in periodontal evaluation

  13 months

• Clinical attachment loss in periodontal evaluation

  13 months

• bleeding of probing in periodontal evaluation

  13 months

Study Arms (1)

Patients with periodontitis and Diabetes Mellitus type 2

EXPERIMENTAL

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.

Interventions

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

Patients with periodontitis and Diabetes Mellitus type 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a. 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).
• b. 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)).

You may not qualify if:

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

Sponsors & Collaborators

• University of Chile: lead

Study Sites (1)

Universidad de Chile

Santiago, Providencia, Chile

RECRUITING

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Periodontitis; Periodontal Diseases; Diabetes Mellitus, Type 2; Cardiovascular Diseases; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Melisa Vera, Specialist in periodontics

  University of Chile

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melisa Vera, Specialist in periodontics

CONTACT

+56976442451; mvera@odontologia.uchile.cl

Jorge Gamonal, Specialist in periodontics

CONTACT

jgamonal@odontologia.uchile.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Periodontist, Universidad de Chile

Model Details: Longitudinal study of difference-in-difference

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: March 26, 2025
• Study Start: August 22, 2023
• Primary Completion: October 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 26, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)