Amelogenins and Systemic Inflammation After Periodontal Surgical Therapy

University of Pisa38 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Periodontal Diseases

Interventions

Periodontal surgeryPROCEDURE

After local anesthesia injection an intrasulcular flap is designed according to minimally invasive techniques. After flap elevation, careful removal of granulation tissues from the periodontal defects is performed. Scaling and root planing of the involved dental roots is ensured and finally suture is placed.

EMD applicationPROCEDURE

Application of Pref-Gel for 2 minutes and then the application on Enamel Matrix Derivatives on the surgically exposed root surface

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital of Pisa

Pisa, Italy

Outcomes

Primary Outcomes

Change of C Reactive Protein (CRP) at 24 hour

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

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