Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03146975
Other study ID # Beta defensins in periodontics
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT03743779 - Mastering Diabetes Pilot Study
Completed NCT03786978 - Pharmaceutical Care in the Reduction of Readmission Rates in Diabetes Melitus N/A
Completed NCT01804803 - DIgital Assisted MONitoring for DiabeteS - I N/A
Completed NCT05039970 - A Real-World Study of a Mobile Device-based Serious Health Game on Session Attendance in the National Diabetes Prevention Program N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Completed NCT04068272 - Safety of Bosentan in Type II Diabetic Patients Phase 1
Completed NCT03243383 - Readmission Prevention Pilot Trial in Diabetes Patients N/A
Completed NCT03730480 - User Performance of the CONTOUR NEXT and CONTOUR TV3 Blood Glucose Monitoring System (BGMS) N/A
Recruiting NCT02690467 - Efficacy, Safety and Acceptability of the New Pen Needle 34gx3,5mm. N/A
Completed NCT02229383 - Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus Phase 3
Completed NCT06181721 - Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Patients With Type 1 and Type 2 Diabetes N/A
Completed NCT05799976 - Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure N/A
Recruiting NCT04489043 - Exercise, Prediabetes and Diabetes After Renal Transplantation. N/A
Withdrawn NCT03319784 - Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients Phase 4
Completed NCT03542084 - Endocrinology Auto-Triggered e-Consults N/A
Completed NCT02229396 - Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo Phase 3
Recruiting NCT05544266 - Rare and Atypical Diabetes Network
Completed NCT01892319 - An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry
Completed NCT05031000 - Blood Glucose Monitoring Systems: Discounter Versus Brand N/A
Recruiting NCT04039763 - RT-CGM in Young Adults at Risk of DKA N/A