Effects of Gum Disease Treatment on Host Defense Factors

Diabetes Mellitus Clinical Trial

— PETREBED  

Official title:

Effects of Non-surgical Periodontal Treatment on Gingival Beta Defensins in Different Clinical Conditions : a Short-term Clinica Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03146975
• Other study ID #: Beta defensins in periodontics
• Status: Completed
• Phase: N/A
• First received: May 8, 2017
• Last updated: June 28, 2017
• Start date: March 2, 2014
• Est. completion date: June 28, 2017

Study information

• Verified date: June 2017
• Source: Federal University of Minas Gerais
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Human immune system produces many different factors, which will influence health-disease statuses. This partially explains why under similar conditions only some people become sick. Therefore, specific analyses of such factors in healthy and diseased patients are crucial for a better knowledge about diseases development and successful treatments. Human beta defensins (hBD) may have a key role in patient's susceptibility to gum diseases. In the lab, high levels of sugar (glucose) could inhibit their expression and contribute to the occurrence of infections associated with diabetic wounds. This study will evaluate if treatment of the most common gum disease in adults influences production of beta defensins by gingiva. Also, clinical improvements and treatment effects on blood glycemic levels will be monitored throughout a 2-month period. Patients with or without gum diseases and with or without diabetes mellitus will be able to participate. After a complete oral examination to determine periodontal status, gingival fluid samples will be collected using paper strips. These samples will be collected before and also two-months after oral treatment and will be analyzed by an immune-enzymatic test named ELISA (Enzyme-Linked Immunosorbent Assay). In weekly sections, one trained specialist will performed treatment of gum diseases under local anesthesia using hand-instruments. Researchers hypothesized that a) levels of defensins would be lower in the presence of periodontal disease when compared to a healthy periodontal condition; b) diabetes would influence production of these immune protective factors; and c) treatment would provide a greater beneficial amount of defensins.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 28, 2017
• Est. primary completion date: June 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Periodontally healthy individuals: at least 15 natural teeth, periodontal pocket depth (PPD) = 3mm e absence of bleeding on probing.

• Periodontitis individuals: at least 15 natural teeth and at least 4 teeth with one or more periodontal sites showing combined PPD = 4mm and clinical attachment level (CAL) = 3mm.

• Compensated diabetic individuals: compensated type 2 diabetes mellitus

• Decompensated diabetic individuals: decompensated type 2 diabetes mellitus (glycated hemoglobin HbA1c >7%)

Exclusion Criteria:

• Past or actual systemic diseases other than diabetes type 2 in the diabetic groups

• Gingivitis

• Gingival overgrowth

• Necrotizing periodontal diseases

• Pregnant or lactating

• smokers or former-smokers

• medication that can influence periodontal status or host response to periodontal therapy

• periodontal therapy in the past 6 months from baseline

• use of systemic or local antibiotics or anti-inflammatory drugs within 3 months prior baseline

Related Conditions & MeSH terms

• Diabetes Mellitus
• Periodontitis

Intervention

Procedure:
• Non-surgical periodontal treatment
Quadrant-wise ultrasonic debridement followed by manual scaling and root planing under local anesthesia provided in weekly sections. Oral hygiene instructions.

Locations

Country	Name	City	State
Brazil	Federal university of minas gerais	Belo Horizonte	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Minas Gerais

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in beta defensins 1, 2 and 3	Increase in the expression of beta defensins 1, 2 and 3 in gingival crevicular fluid samples	Baseline and 60 days
Secondary	Changes in periodontal pocket depth	Reduction in mean periodontal pocket depth	Baseline and 60 days
Secondary	Changes in blood glycemic levels	Reduction in blood glucose levels and levels of glycated hemoglobin	Baseline and 60 days
Secondary	Changes in percentage of diseased sites	Reduction in the percentage of sites showing PPD>4mm and/or bleeding on probing	Baseline and 60 days