Effect of Periodontal Therapy in the Systemic Status of Individuals With Chronic Periodontitis and Diabetes Type 2

Effect of Mechanical Periodontal Therapy in the Microbiological, Immunocellular and Immunoglobulin Profiles and in the Dosage of Pro and Anti-inflammatory Cytokines From Peripheral Blood and Saliva of Subjects With Chronic Periodontitis and Diabetes Type 2

This study will evaluate if periodontal mechanical treatment is capable to alter immunological and genetical parameters related to systemic health in patients with chronic periodontitis ant diabetes type 2.

Study Overview

• Status: Terminated
• Conditions: Chronic Periodontitis; Diabetes Type 2
• Intervention / Treatment: Device: Mechanical periodontal therapy; Procedure: nonsurgical periodontal therapy

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• Brazil
  • Distrito Federal
    • Brasilia, Distrito Federal, Brazil, 70790-123
      • Priscilla Farias Naiff

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Periodontitis group:

• Minimum of 15 teeh;
• At least 30% of sites with periodontal probing depth ≥ 4 mm and at least two teeth with CAL ≥ 3 mm; Age ≥30 years;

Control group:

• Systemically healthy;
• 20 teeth;
• Probing depth ≤3 mm, clinical attachment level ≤3 mm , ≤10% of sites with bleeding on probing.

Exclusion Criteria:

• Periodontal treatment in the last six months;
• Continued use of medications such as antibiotics, immunomodulatory, anti-inflammatory drugs or corticosteroids in the last three months;
• Systemic diseases that interfere with periodontal condition, except for diabetes for the test group (HIV, cancer, immune disorders, acute infections, severe allergies, gastrointestinal or kidney disease, morbid obesity [BMI 40 kg / m2] or underweight [evil nourished BMI <18.5 kg / m2], etc.); Pregnant or lactating; smoking; Age <30 years; Indigenous groups.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
root planning	Device: Mechanical periodontal therapy; Other Names: periodontal debridment; Procedure: nonsurgical periodontal therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evidence of alteration in periodontal pathogens by PCR	Evaluate wich periodontal pathogens are detected before and after treatment	One year
Evidence of alteration of immunocellular response by flowcytometry	Fenotype Monocytes, PMN, NK cells, T cells, B cells before and after periodontal treatment	one year
Evidence of alteration on pro and anti-inflammatory cytokines by CBA	Dosage of cytokines before and after periodontal treatment	One year

Collaborators and Investigators

• Sponsor: University of Brasilia
• Collaborators: Brasilia University Hospital; Catholic University of Brasília

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2015
• Primary Completion (Actual): September 1, 2019
• Study Completion (Actual): August 1, 2020

Study Registration Dates

• First Submitted: October 26, 2015
• First Submitted That Met QC Criteria: October 26, 2015
• First Posted (Estimate): October 28, 2015

Study Record Updates

• Last Update Posted (Actual): August 24, 2020
• Last Update Submitted That Met QC Criteria: August 20, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Periodontitis; Chronic Periodontitis
• Other Study ID Numbers: CAAE 46609515.7.0000.0030