Effects of Gum Disease Treatment on Host Defense Factors

NCT03146975 | Completed DMC

• 1 other identifier: Beta defensins in periodontics
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis; Diabetes Mellitus

Keywords

Beta-defensins; Chronic periodontitis; Diabetes mellitus; Non-surgical periodontal therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Changes in periodontal pocket depth

  Baseline and 60 days

• Changes in blood glycemic levels

  Baseline and 60 days

• Changes in percentage of diseased sites

  Baseline and 60 days

Study Arms (6)

Healthy

NO INTERVENTION

Periodontitis without diabetes

EXPERIMENTAL

Procedure: Non-surgical periodontal treatment

Periodontitis compensated diabetes

EXPERIMENTAL

Procedure: Non-surgical periodontal treatment

Periodontitis decompensated diabetes

EXPERIMENTAL

Procedure: Non-surgical periodontal treatment

Compensated diabetes non periodontitis

NO INTERVENTION

Decompensated diabetes non periodontitis

NO INTERVENTION

Interventions

Non-surgical periodontal treatment PROCEDURE

Quadrant-wise ultrasonic debridement followed by manual scaling and root planing under local anesthesia provided in weekly sections. Oral hygiene instructions.

Periodontitis compensated diabetes; Periodontitis decompensated diabetes; Periodontitis without diabetes

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%)

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of Minas Gerais: lead

Study Sites (1)

Federal university of minas gerais

Belo Horizonte, Minas Gerais, Brazil

Location

MeSH Terms

Conditions

Periodontitis; Diabetes Mellitus; Chronic Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Fernando O Costa, PhD

  Dean periodontics department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of periodontology

Study Record Dates

• First Submitted: May 8, 2017
• First Posted: May 10, 2017
• Study Start: March 2, 2014
• Primary Completion: June 20, 2017
• Study Completion: June 28, 2017
• Last Updated: July 2, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)