Clinical trial NCT03146975: Effects of Gum Disease Treatment on Host Defense Factors
Official title: Effects of Non-surgical Periodontal Treatment on Gingival Beta Defensins in Different Clinical Conditions : a Short-term Clinica Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Diabetes Mellitus
Keywords: Beta-defensins
Chronic periodontitis
Diabetes mellitus
Non-surgical periodontal therapy
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
First posted: 2017-05-10
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in beta defensins 1, 2 and 3
timeFrame: Baseline and 60 days
Secondary outcomes:
measure: Changes in periodontal pocket depth
timeFrame: Baseline and 60 days
measure: Changes in blood glycemic levels
timeFrame: Baseline and 60 days
measure: Changes in percentage of diseased sites
timeFrame: Baseline and 60 days
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Federal university of minas gerais
state: Minas Gerais
Study officials:
affiliation: Dean periodontics department
name: Fernando O Costa, PhD
role: PRINCIPAL_INVESTIGATOR
References: