Amelogenins and Systemic Inflammation After Periodontal Surgical Therapy

Study Overview
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Brief Summary
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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.

Official Title
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Enamel Matrix Derivatives on Systemic Inflammation After Periodontal Surgical Therapy

Conditions
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Periodontal Diseases

Intervention / Treatment
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* Procedure: Periodontal surgery
* Procedure: EMD application


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Periodontal Surgery with EMD<br>A surgical periodontal flap was elevated, degranulation of inflammatory tissues and dental debridement was performed. After carefully cleaning root dental surfaces, EMD was placed inside the infrabony periodontal defect. Suture were placed to maintain wound stability. | Procedure: Periodontal surgery<br>* 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.<br>* Other names: Open Flap Debridement;Procedure: EMD application<br>* Application of Pref-Gel for 2 minutes and then the application on Enamel Matrix Derivatives on the surgically exposed root surface<br>* Other names: Amelogenins application;|
| Active Comparator: Periodontal Surgery<br>A surgical periodontal flap was elevated, degranulation of inflammatory tissues and dental debridement was performed. Suture were placed to maintain wound stability. | Procedure: Periodontal surgery<br>* 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.<br>* Other names: Open Flap Debridement;|

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 | Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment | 
| Cholesterol | analyzed though blood sampling. Unit of measure: mg/dL | Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment | 
| Triglycerides | analyzed though blood sampling. Unit of measure: mg/dL | Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment | 
| HDL Cholesterol | analyzed though blood sampling. Unit of measure: mg/dL | Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment | 
| LDL Cholesterol | analyzed though blood sampling. Unit of measure: mg/dL | Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment | 
| Fibrinogen | analyzed though blood sampling. Unit of measure: mg/dL | Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment | 
| D-Dimer | analyzed though blood sampling. Unit of measure: mg/L | Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment | 
| Cystatin C | analyzed though blood sampling. Unit of measure: mg/L | Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment | 
| C Reactive Protein (CRP) | CRP analyzed though blood sampling. Unit of measure: mg/L | Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment | 
| Clinical attachment level (CAL) at deepest site | Changes in CAL , measured orally through clinical examination. Unit of measure: mm | Measured at Baseline and 6 months after treatment | 
| Pocket probing depth (PPD) at deepest site | Changes in PPD , measured orally through clinical examination. Unit of measure: mm | Measured at Baseline and 6 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 6 months after treatment |