The Impact of Enamel Matrix Derivatives on Markers of Systemic Inflammation After Flapless Periodontal Therapy

University of Pisa1 site in 1 country38 target enrollmentDecember 1, 2015

ConditionsPeriodontal Diseases

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Periodontal Diseases
Sponsor: University of Pisa
Enrollment: 38
Locations: 1
Primary Endpoint: Change of C Reactive Protein (CRP) at 24 hour
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of this study is to compare periodontal treatment with or without the adjunct of an enamel matrix derivative in terms of acute-phase responses in healthy patients.

Detailed Description

Patients with periodontitis will be randomly allocated to two groups. In both groups, periodontal root instrumentation will be performed. In the test group, an additional flapless application of enamel matrix derivatives will be granted for sites with pockets deeper than 5 mm. Systemic inflammation as measured through blood testing and local parameters of periodontal health will be measured at baseline and three months after treatment completion.

Registry

clinicaltrials.gov

Start Date

December 1, 2015

End Date

June 1, 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Pisa

Responsible Party

Principal Investigator

Filippo Graziani, DDS MClinDent PhD

Professor

University of Pisa

Eligibility Criteria

Inclusion Criteria

•Good health
•No previous periodontal treatment
•Presence of Periodontitis (Clinical attachment loss of at least 3 mm in 2 or more non-adjacent teeth)
•Ability to understand the study procedures and comply with them through the length of the study

Exclusion Criteria

•Pregnancy and breast feeding
•Need for antibiotic treatment during periodontal therapy
•Chronic infections
•Systemic diseases
•Patients who report current smoking over 20 cigarettes per day

Outcomes

Primary Outcomes

Change of C Reactive Protein (CRP) at 24 hour

Time Frame: Collected at Baseline and 24 hours in order to calculate the changes

CRP analyzed though blood sampling. Unit of measure: mg/L

Secondary Outcomes

Fibrinogen(Collected at Baseline, 24 hours and 3 months after treatment)
LDL Cholesterol(Collected at Baseline, 24 hours and 3 months after treatment)
HDL Cholesterol(Collected at Baseline, 24 hours and 3 months after treatment)
D-Dimer(Collected at Baseline, 24 hours and 3 months after treatment)
Clinical attachment level (CAL)(Measured at Baseline and 3 months after treatment)
Percentage of sites with Pocket probing depth deeper than 3mm(Measured at Baseline and 3 months after treatment)
Cystatin C(Collected at Baseline, 24 hours and 3 months after treatment)
Number of sites with Pocket probing depth deeper than 3mm(Measured at Baseline and 3 months after treatment)
Triglyceride(Collected at Baseline, 24 hours and 3 months after treatment)
Cholesterol(Collected at Baseline, 24 hours and 3 months after treatment)
Full-mouth plaque score (FMPS)(Measured at Baseline and 3 months after treatment)
Recession of the gingival margin (REC)(Measured at Baseline and 3 months after treatment)
Glucose(Baseline, 24 hours and 3 months after treatment)
Full-mouth bleeding score (FMBS)(Measured at Baseline and 3 months after treatment)
Number of sites with Pocket probing depth deeper than 5mm(Measured at Baseline and 3 months after treatment)
Number of bleeding sites which measured Pocket probing depth deeper than 5mm at baseline(Measured at Baseline and 3 months after treatment)
Pocket probing depth (PPD)(Measured at Baseline and 3 months after treatment)
Percentage of bleeding sites which measured Pocket probing depth deeper than 5mm at baseline(Measured at Baseline and 3 months after treatment)
C Reactive Protein (CRP) at 3 months(Collected 3 months after treatment)
Percentage of sites with Pocket probing depth deeper than 5mm(Measured at Baseline and 3 months after treatment)