Enamel Matrix Derivatives on Systemic Inflammation After Periodontal Therapy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Periodontal Diseases

Intervention / Treatment
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* Procedure: Root Instrumentation
* Device: EMD Application


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Root Instrumentation + EMD Application<br>Periodontal treatment is delivered with ultrasonic instrumentation performed with fine tips. The approach chosen is the one-stage full-mouth ultrasonic debridement in which all the treatment of diseased sites is performed within one hour. In this group, at the end of the instrumentation enamel matrix derivatives is placed in all sites with a periodontal pocket depth deeper than 5mm. | Procedure: Root Instrumentation<br>* Instrumentation of the root surface in order to achieve debridement<br>Device: EMD Application<br>* Application of Enamel Matrix Derivatives on the root surface after debridement in sites with probing depth deeper than 5 mm<br>|
| Active Comparator: Root Instrumentation<br>Periodontal treatment is delivered with ultrasonic instrumentation performed with fine tips. The approach chosen is the one-stage full-mouth ultrasonic debridement in which all the treatment of diseased sites is performed within one hour. | Procedure: Root Instrumentation<br>* Instrumentation of the root surface in order to achieve debridement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of C Reactive Protein (CRP) at 24 hour | CRP analyzed though blood sampling. Unit of measure: mg/L | Collected at Baseline and 24 hours in order to calculate the changes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose | analyzed though blood sampling. Unit of measure: mg/dL | Baseline, 24 hours and 3 months after treatment | 
| Cholesterol | analyzed though blood sampling. Unit of measure: mg/dL | Collected at Baseline, 24 hours and 3 months after treatment | 
| LDL Cholesterol | analyzed though blood sampling. Unit of measure: mg/dL | Collected at Baseline, 24 hours and 3 months after treatment | 
| HDL Cholesterol | analyzed though blood sampling. Unit of measure: mg/dL | Collected at Baseline, 24 hours and 3 months after treatment | 
| Triglyceride | analyzed though blood sampling. Unit of measure: mg/dL | Collected at Baseline, 24 hours and 3 months after treatment | 
| Fibrinogen | analyzed though blood sampling. Unit of measure: mg/dL | Collected at Baseline, 24 hours and 3 months after treatment | 
| D-Dimer | analyzed though blood sampling. Unit of measure: mg/L | Collected at Baseline, 24 hours and 3 months after treatment | 
| Cystatin C | analyzed though blood sampling. Unit of measure: mg/L | 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. | Measured at Baseline and 3 months after treatment | 
| Full-mouth bleeding score (FMBS) | Changes of Full-mouth bleeding score, measuring the number of gingival areas that bleed after gingival probe passage. It is measured orally through clinical examination. Unit of measure %. The scale ranges from 0% ( minimum value, i.e. gingival inflammation is absent) to 100% ( maximum value: all gingival areas are inflamed). 0% would the ideal value. No sub-scales are included. | Measured at Baseline and 3 months after treatment | 
| Pocket probing depth (PPD) | Changes in PPD , measured orally through clinical examination. Unit of measure: mm | Measured at Baseline and 3 months after treatment | 
| Clinical attachment level (CAL) | Changes in CAL , measured orally through clinical examination. Unit of measure: mm | Measured at Baseline and 3 months after treatment | 
| Recession of the gingival margin (REC) | Changes in REC, measured orally through clinical examination. Unit of measure: mm | Measured at Baseline and 3 months after treatment | 
| Number of sites with Pocket probing depth deeper than 3mm | Changes, measured orally through clinical examination. Unit of measure: N | Measured at Baseline and 3 months after treatment | 
| Number of sites with Pocket probing depth deeper than 5mm | Changes, measured orally through clinical examination. Unit of measure: N | Measured at Baseline and 3 months after treatment | 
| Percentage of sites with Pocket probing depth deeper than 3mm | Changes, measured orally through clinical examination. Unit of measure: % | Measured at Baseline and 3 months after treatment | 
| Percentage of sites with Pocket probing depth deeper than 5mm | Changes, measured orally through clinical examination. Unit of measure: % | Measured at Baseline and 3 months after treatment | 
| Percentage of bleeding sites which measured Pocket probing depth deeper than 5mm at baseline | Changes , measured orally through clinical examination. Unit of measure: % | Measured at Baseline and 3 months after treatment | 
| Number of bleeding sites which measured Pocket probing depth deeper than 5mm at baseline | Changes , measured orally through clinical examination. Unit of measure: N | Measured at Baseline and 3 months after treatment | 
| C Reactive Protein (CRP) at 3 months | CRP analyzed though blood sampling. Unit of measure: mg/L | Collected 3 months after treatment |