Enamel Matrix Derivatives on Systemic Inflammation After Periodontal Therapy (PERIOEMD-2)

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

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.

Study Overview

• Status: Completed
• Conditions: Periodontal Diseases
• Intervention / Treatment: Procedure: Root Instrumentation; Device: EMD Application

Detailed Description

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
• 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 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Root Instrumentation + EMD Application; 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; Instrumentation of the root surface in order to achieve debridement; Device: EMD Application; Application of Enamel Matrix Derivatives on the root surface after debridement in sites with probing depth deeper than 5 mm
Active Comparator: Root Instrumentation; 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; Instrumentation of the root surface in order to achieve 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
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 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 5mm	Changes, measured orally through clinical examination. Unit of measure: %	Measured at Baseline and 3 months after treatment
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
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
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 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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Graziani F, Gennai S, Petrini M, Bettini L, Tonetti M. Enamel matrix derivative stabilizes blood clot and improves clinical healing in deep pockets after flapless periodontal therapy: A Randomized Clinical Trial. J Clin Periodontol. 2019 Feb;46(2):231-240. doi: 10.1111/jcpe.13074.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: April 30, 2018
• First Submitted That Met QC Criteria: May 31, 2018
• First Posted (Actual): June 4, 2018

Study Record Updates

• Last Update Posted (Actual): July 6, 2018
• Last Update Submitted That Met QC Criteria: July 4, 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: 3649/15B

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