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

Primary Purpose

Periodontal Diseases

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Root Instrumentation
EMD Application
Sponsored by
University of Pisa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Diseases

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital of Pisa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Root Instrumentation + EMD Application

Root Instrumentation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change of C Reactive Protein (CRP) at 24 hour
CRP analyzed though blood sampling. Unit of measure: mg/L

Secondary Outcome Measures

Glucose
analyzed though blood sampling. Unit of measure: mg/dL
Cholesterol
analyzed though blood sampling. Unit of measure: mg/dL
LDL Cholesterol
analyzed though blood sampling. Unit of measure: mg/dL
HDL Cholesterol
analyzed though blood sampling. Unit of measure: mg/dL
Triglyceride
analyzed though blood sampling. Unit of measure: mg/dL
Fibrinogen
analyzed though blood sampling. Unit of measure: mg/dL
D-Dimer
analyzed though blood sampling. Unit of measure: mg/L
Cystatin C
analyzed though blood sampling. Unit of measure: mg/L
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.
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.
Pocket probing depth (PPD)
Changes in PPD , measured orally through clinical examination. Unit of measure: mm
Clinical attachment level (CAL)
Changes in CAL , measured orally through clinical examination. Unit of measure: mm
Recession of the gingival margin (REC)
Changes in REC, measured orally through clinical examination. Unit of measure: mm
Number of sites with Pocket probing depth deeper than 3mm
Changes, measured orally through clinical examination. Unit of measure: N
Number of sites with Pocket probing depth deeper than 5mm
Changes, measured orally through clinical examination. Unit of measure: N
Percentage of sites with Pocket probing depth deeper than 3mm
Changes, measured orally through clinical examination. Unit of measure: %
Percentage of sites with Pocket probing depth deeper than 5mm
Changes, measured orally through clinical examination. Unit of measure: %
Percentage of bleeding sites which measured Pocket probing depth deeper than 5mm at baseline
Changes , measured orally through clinical examination. Unit of measure: %
Number of bleeding sites which measured Pocket probing depth deeper than 5mm at baseline
Changes , measured orally through clinical examination. Unit of measure: N
C Reactive Protein (CRP) at 3 months
CRP analyzed though blood sampling. Unit of measure: mg/L

Full Information

First Posted
April 30, 2018
Last Updated
July 4, 2018
Sponsor
University of Pisa
Collaborators
Institut Straumann AG
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1. Study Identification

Unique Protocol Identification Number
NCT03544931
Brief Title
Enamel Matrix Derivatives on Systemic Inflammation After Periodontal Therapy
Acronym
PERIOEMD-2
Official Title
The Impact of Enamel Matrix Derivatives on Markers of Systemic Inflammation After Flapless Periodontal Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
December 1, 2015 (Actual)
Primary Completion Date
January 1, 2018 (Actual)
Study Completion Date
June 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pisa
Collaborators
Institut Straumann AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Root Instrumentation + EMD Application
Arm Type
Experimental
Arm Description
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.
Arm Title
Root Instrumentation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Root Instrumentation
Intervention Description
Instrumentation of the root surface in order to achieve debridement
Intervention Type
Device
Intervention Name(s)
EMD Application
Intervention Description
Application of Enamel Matrix Derivatives on the root surface after debridement in sites with probing depth deeper than 5 mm
Primary Outcome Measure Information:
Title
Change of C Reactive Protein (CRP) at 24 hour
Description
CRP analyzed though blood sampling. Unit of measure: mg/L
Time Frame
Collected at Baseline and 24 hours in order to calculate the changes
Secondary Outcome Measure Information:
Title
Glucose
Description
analyzed though blood sampling. Unit of measure: mg/dL
Time Frame
Baseline, 24 hours and 3 months after treatment
Title
Cholesterol
Description
analyzed though blood sampling. Unit of measure: mg/dL
Time Frame
Collected at Baseline, 24 hours and 3 months after treatment
Title
LDL Cholesterol
Description
analyzed though blood sampling. Unit of measure: mg/dL
Time Frame
Collected at Baseline, 24 hours and 3 months after treatment
Title
HDL Cholesterol
Description
analyzed though blood sampling. Unit of measure: mg/dL
Time Frame
Collected at Baseline, 24 hours and 3 months after treatment
Title
Triglyceride
Description
analyzed though blood sampling. Unit of measure: mg/dL
Time Frame
Collected at Baseline, 24 hours and 3 months after treatment
Title
Fibrinogen
Description
analyzed though blood sampling. Unit of measure: mg/dL
Time Frame
Collected at Baseline, 24 hours and 3 months after treatment
Title
D-Dimer
Description
analyzed though blood sampling. Unit of measure: mg/L
Time Frame
Collected at Baseline, 24 hours and 3 months after treatment
Title
Cystatin C
Description
analyzed though blood sampling. Unit of measure: mg/L
Time Frame
Collected at Baseline, 24 hours and 3 months after treatment
Title
Full-mouth plaque score (FMPS)
Description
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.
Time Frame
Measured at Baseline and 3 months after treatment
Title
Full-mouth bleeding score (FMBS)
Description
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.
Time Frame
Measured at Baseline and 3 months after treatment
Title
Pocket probing depth (PPD)
Description
Changes in PPD , measured orally through clinical examination. Unit of measure: mm
Time Frame
Measured at Baseline and 3 months after treatment
Title
Clinical attachment level (CAL)
Description
Changes in CAL , measured orally through clinical examination. Unit of measure: mm
Time Frame
Measured at Baseline and 3 months after treatment
Title
Recession of the gingival margin (REC)
Description
Changes in REC, measured orally through clinical examination. Unit of measure: mm
Time Frame
Measured at Baseline and 3 months after treatment
Title
Number of sites with Pocket probing depth deeper than 3mm
Description
Changes, measured orally through clinical examination. Unit of measure: N
Time Frame
Measured at Baseline and 3 months after treatment
Title
Number of sites with Pocket probing depth deeper than 5mm
Description
Changes, measured orally through clinical examination. Unit of measure: N
Time Frame
Measured at Baseline and 3 months after treatment
Title
Percentage of sites with Pocket probing depth deeper than 3mm
Description
Changes, measured orally through clinical examination. Unit of measure: %
Time Frame
Measured at Baseline and 3 months after treatment
Title
Percentage of sites with Pocket probing depth deeper than 5mm
Description
Changes, measured orally through clinical examination. Unit of measure: %
Time Frame
Measured at Baseline and 3 months after treatment
Title
Percentage of bleeding sites which measured Pocket probing depth deeper than 5mm at baseline
Description
Changes , measured orally through clinical examination. Unit of measure: %
Time Frame
Measured at Baseline and 3 months after treatment
Title
Number of bleeding sites which measured Pocket probing depth deeper than 5mm at baseline
Description
Changes , measured orally through clinical examination. Unit of measure: N
Time Frame
Measured at Baseline and 3 months after treatment
Title
C Reactive Protein (CRP) at 3 months
Description
CRP analyzed though blood sampling. Unit of measure: mg/L
Time Frame
Collected 3 months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University Hospital of Pisa
City
Pisa
ZIP/Postal Code
56126
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30663788
Citation
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.
Results Reference
derived

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Enamel Matrix Derivatives on Systemic Inflammation After Periodontal Therapy

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