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

Terminated

• Conditions: Chronic Periodontitis; Diabetes Type 2
• Interventions: Device: Mechanical periodontal therapy; Procedure: nonsurgical periodontal therapy

• Registration Number: NCT02589314
• Lead Sponsor: University of Brasilia

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-26
• Study First Submitted QC: 2015-10-26
• Study First Posted: 2015-10-28
• Study Start: 2015-11
• Primary Completion: 2019-09
• Status Verified: 2020-08
• Study Completion: 2020-08
• Last Update Submitted: 2020-08-20
• Last Update Posted: 2020-08-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
root planning	Mechanical periodontal therapy	-
root planning	nonsurgical periodontal therapy	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Priscilla Farias Naiff; 🇧🇷 Brasilia, Distrito Federal, Brazil