Enamel Matrix Derivatives on Systemic Inflammation After Periodontal Therapy

University of Pisa38 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Periodontal Diseases

Interventions

Root InstrumentationPROCEDURE

Instrumentation of the root surface in order to achieve debridement

EMD ApplicationDEVICE

Application of Enamel Matrix Derivatives on the root surface after debridement in sites with probing depth deeper than 5 mm

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

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

Secondary Outcomes

Glucose

analyzed though blood sampling. Unit of measure: mg/dL

Time frame: Baseline, 24 hours and 3 months after treatment

Cholesterol

analyzed though blood sampling. Unit of measure: mg/dL

Time frame: Collected at Baseline, 24 hours and 3 months after treatment

LDL Cholesterol

analyzed though blood sampling. Unit of measure: mg/dL

Time frame: Collected at Baseline, 24 hours and 3 months after treatment

HDL Cholesterol

analyzed though blood sampling. Unit of measure: mg/dL

Time frame: Collected at Baseline, 24 hours and 3 months after treatment

Triglyceride

analyzed though blood sampling. Unit of measure: mg/dL

Time frame: Collected at Baseline, 24 hours and 3 months after treatment

Fibrinogen

analyzed though blood sampling. Unit of measure: mg/dL

Time frame: Collected at Baseline, 24 hours and 3 months after treatment

D-Dimer

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

Time frame: Collected at Baseline, 24 hours and 3 months after treatment

Data from ClinicalTrials.gov

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Cystatin C

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

Time frame: Collected at Baseline, 24 hours and 3 months after treatment

Full-mouth plaque score (FMPS)

Changes in Full-mouth plaque score, measuring the amount of dental plaque on the teeth orally through clinical examination. Unit of measure %. The scale ranges from 0% ( minimum value, i.e. plaque absent) to 100% ( maximum value: all areas are occupied by plaque). 0% would the ideal value. No sub-scales are included.