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

Primary Purpose

Periodontal Diseases

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Periodontal surgery
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 - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital of Pisa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Periodontal Surgery with EMD

Periodontal Surgery

Arm Description

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.

A surgical periodontal flap was elevated, degranulation of inflammatory tissues and dental debridement was performed. Suture were placed to maintain wound stability.

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
Triglycerides
analyzed though blood sampling. Unit of measure: mg/dL
HDL Cholesterol
analyzed though blood sampling. Unit of measure: mg/dL
LDL Cholesterol
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
C Reactive Protein (CRP)
CRP analyzed though blood sampling. Unit of measure: mg/L
Clinical attachment level (CAL) at deepest site
Changes in CAL , measured orally through clinical examination. Unit of measure: mm
Pocket probing depth (PPD) at deepest site
Changes in PPD , 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

Full Information

First Posted
July 4, 2018
Last Updated
July 17, 2018
Sponsor
University of Pisa
Collaborators
Institut Straumann AG
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1. Study Identification

Unique Protocol Identification Number
NCT03590093
Brief Title
Amelogenins and Systemic Inflammation After Periodontal Surgical Therapy
Acronym
PERIOEMD-1
Official Title
Enamel Matrix Derivatives on Systemic Inflammation After Periodontal Surgical Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
November 1, 2013 (Actual)
Primary Completion Date
December 1, 2017 (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 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.

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
InvestigatorOutcomes Assessor
Masking Description
The examiner were not aware of group allocation
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Periodontal Surgery with EMD
Arm Type
Experimental
Arm Description
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.
Arm Title
Periodontal Surgery
Arm Type
Active Comparator
Arm Description
A surgical periodontal flap was elevated, degranulation of inflammatory tissues and dental debridement was performed. Suture were placed to maintain wound stability.
Intervention Type
Procedure
Intervention Name(s)
Periodontal surgery
Other Intervention Name(s)
Open Flap Debridement
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
EMD application
Other Intervention Name(s)
Amelogenins application
Intervention Description
Application of Pref-Gel for 2 minutes and then the application on Enamel Matrix Derivatives on the surgically exposed root surface
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
Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment
Title
Cholesterol
Description
analyzed though blood sampling. Unit of measure: mg/dL
Time Frame
Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment
Title
Triglycerides
Description
analyzed though blood sampling. Unit of measure: mg/dL
Time Frame
Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment
Title
HDL Cholesterol
Description
analyzed though blood sampling. Unit of measure: mg/dL
Time Frame
Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment
Title
LDL Cholesterol
Description
analyzed though blood sampling. Unit of measure: mg/dL
Time Frame
Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment
Title
Fibrinogen
Description
analyzed though blood sampling. Unit of measure: mg/dL
Time Frame
Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment
Title
D-Dimer
Description
analyzed though blood sampling. Unit of measure: mg/L
Time Frame
Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment
Title
Cystatin C
Description
analyzed though blood sampling. Unit of measure: mg/L
Time Frame
Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment
Title
C Reactive Protein (CRP)
Description
CRP analyzed though blood sampling. Unit of measure: mg/L
Time Frame
Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment
Title
Clinical attachment level (CAL) at deepest site
Description
Changes in CAL , measured orally through clinical examination. Unit of measure: mm
Time Frame
Measured at Baseline and 6 months after treatment
Title
Pocket probing depth (PPD) at deepest site
Description
Changes in PPD , measured orally through clinical examination. Unit of measure: mm
Time Frame
Measured at Baseline and 6 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 6 months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
32163634
Citation
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.
Results Reference
derived

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Amelogenins and Systemic Inflammation After Periodontal Surgical Therapy

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