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

Chronic Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02589314
• Other study ID #: CAAE 46609515.7.0000.0030
• Status: Terminated
• Start date: November 2015
• Est. completion date: August 2020

Study information

• Verified date: August 2020
• Source: University of Brasilia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 90
• Est. completion date: August 2020
• Est. primary completion date: September 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Periodontitis
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes Type 2
• Periodontitis

Intervention

Device:
• Mechanical periodontal therapy

Procedure:
• nonsurgical periodontal therapy

Locations

Country	Name	City	State
Brazil	Priscilla Farias Naiff	Brasilia	Distrito Federal

Sponsors (3)

Lead Sponsor	Collaborator
University of Brasilia	Brasilia University Hospital, Catholic University of Brasília

Country where clinical trial is conducted

Brazil, 

Outcome

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