NCT03590093

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 4, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 18, 2018

Completed
Last Updated

July 18, 2018

Status Verified

July 1, 2018

Enrollment Period

4.1 years

First QC Date

July 4, 2018

Last Update Submit

July 17, 2018

Conditions

Periodontal Diseases

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • Glucose

    Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment

  • Cholesterol

    Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment

  • Triglycerides

    Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment

  • HDL Cholesterol

    Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment

  • LDL Cholesterol

    Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment

  • +7 more secondary outcomes

Study Arms (2)

Periodontal Surgery with EMD

EXPERIMENTAL

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 surgeryProcedure: EMD application

Periodontal Surgery

ACTIVE COMPARATOR

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

Interventions

Periodontal surgeryPROCEDURE

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.

Also known as: Open Flap Debridement
Periodontal SurgeryPeriodontal Surgery with EMD
EMD applicationPROCEDURE

Application of Pref-Gel for 2 minutes and then the application on Enamel Matrix Derivatives on the surgically exposed root surface

Also known as: Amelogenins application
Periodontal Surgery with EMD

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Pisa

Pisa, 56126, Italy

Location

Related Publications (1)

  • 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.

    PMID: 32163634DERIVED

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The examiner were not aware of group allocation
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

July 4, 2018

First Posted

July 18, 2018

Study Start

November 1, 2013

Primary Completion

December 1, 2017

Study Completion

June 1, 2018

Last Updated

July 18, 2018

Record last verified: 2018-07

Locations

IT(1)