Enamel Matrix Derivatives on Systemic Inflammation After Periodontal Surgical Therapy

University of Pisa1 site in 1 country38 target enrollmentNovember 1, 2013

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 surgical treatment of periodontal infrabony defects with and without the adjunct of an enemal matrix derivative (EMD) in terms of acute-phase responses, in systemic healthy patients.

Registry

clinicaltrials.gov

Start Date

November 1, 2013

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

Clinical Professor

University of Pisa

Eligibility Criteria

Inclusion Criteria

•Good health
•No previous periodontal surgical treatment
•Indication for periodontal surgery (intrabony defects to be at least 4 mm deep)
•Ability to understand the study procedures and comply with them through the length of the study

Exclusion Criteria

•Pregnancy, breast feeding or taking oral contraceptive (all non-drug contraceptives will be allowed)
•The need for antibiotic therapy to undergo periodontal therapy
•Chronic infections
•Systemic diseases
•Patients who report current smoking over 20 cigarettes per day or pipe or cigar

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

Glucose(Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment)
Triglycerides(Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment)
HDL Cholesterol(Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment)
LDL Cholesterol(Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment)
Fibrinogen(Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment)
D-Dimer(Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment)
Cystatin C(Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment)
C Reactive Protein (CRP)(Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment)
Pocket probing depth (PPD) at deepest site(Measured at Baseline and 6 months after treatment)
Cholesterol(Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment)
Clinical attachment level (CAL) at deepest site(Measured at Baseline and 6 months after treatment)
Recession of the gingival margin (REC)(Measured at Baseline and 6 months after treatment)