Amelogenins and Systemic Inflammation After Periodontal Surgical Therapy (PERIOEMD-1)

Enamel Matrix Derivatives on Systemic Inflammation After Periodontal Surgical Therapy

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 Overview

• Status: Completed
• Conditions: Periodontal Diseases
• Intervention / Treatment: Procedure: Periodontal surgery; Procedure: EMD application

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Pisa, Italy, 56126
    • University Hospital of Pisa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Periodontal Surgery with EMD; 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; 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.; Other Names: Open Flap Debridement; Procedure: EMD application; Application of Pref-Gel for 2 minutes and then the application on Enamel Matrix Derivatives on the surgically exposed root surface; Other Names: Amelogenins application
Active Comparator: Periodontal Surgery; 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; 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.; Other Names: Open Flap Debridement

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Pisa
• Collaborators: Institut Straumann AG

Publications and helpful links

General Publications

• Graziani F, Peric M, Marhl U, Petrini M, Bettini L, Tonetti M, Gennai S. Local application of enamel matrix derivative prevents acute systemic inflammation after periodontal regenerative surgery: A randomized controlled clinical trial. J Clin Periodontol. 2020 Jun;47(6):747-755. doi: 10.1111/jcpe.13270. Epub 2020 Mar 12.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2013
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: July 4, 2018
• First Submitted That Met QC Criteria: July 17, 2018
• First Posted (Actual): July 18, 2018

Study Record Updates

• Last Update Posted (Actual): July 18, 2018
• Last Update Submitted That Met QC Criteria: July 17, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Stomatognathic Diseases; Mouth Diseases; Inflammation; Periodontal Diseases
• Other Study ID Numbers: 3649/13A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No