Amelogenins and Systemic Inflammation After Periodontal Surgical Therapy

Not Applicable

Completed

• Conditions: Periodontal Diseases
• Interventions: Procedure: Periodontal surgery; Procedure: EMD application

• Registration Number: NCT03590093
• Lead Sponsor: University of Pisa

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-01
• Primary Completion: 2017-12-01
• Study Completion: 2018-06-01
• Status Verified: 2018-07
• Study First Submitted: 2018-07-04
• Study First Submitted QC: 2018-07-17
• Last Update Submitted: 2018-07-17
• Study First Posted: 2018-07-18
• Last Update Posted: 2018-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Periodontal Surgery	Periodontal surgery	A surgical periodontal flap was elevated, degranulation of inflammatory tissues and dental debridement was performed. Suture were placed to maintain wound stability.
Periodontal Surgery with EMD	Periodontal surgery	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.
Periodontal Surgery with EMD	EMD application	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital of Pisa; 🇮🇹 Pisa, Italy