NCT03544931

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.

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 Dec 2015

Typical duration 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

December 1, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2018

Completed
Last Updated

July 6, 2018

Status Verified

July 1, 2018

Enrollment Period

2.1 years

First QC Date

April 30, 2018

Last Update Submit

July 4, 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 (20)

  • Glucose

    Baseline, 24 hours and 3 months after treatment

  • Cholesterol

    Collected at Baseline, 24 hours and 3 months after treatment

  • LDL Cholesterol

    Collected at Baseline, 24 hours and 3 months after treatment

  • HDL Cholesterol

    Collected at Baseline, 24 hours and 3 months after treatment

  • Triglyceride

    Collected at Baseline, 24 hours and 3 months after treatment

  • +15 more secondary outcomes

Study Arms (2)

Root Instrumentation + EMD Application

EXPERIMENTAL

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 InstrumentationDevice: EMD Application

Root Instrumentation

ACTIVE COMPARATOR

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

Interventions

Root InstrumentationPROCEDURE

Instrumentation of the root surface in order to achieve debridement

Root InstrumentationRoot Instrumentation + EMD Application
EMD ApplicationDEVICE

Application of Enamel Matrix Derivatives on the root surface after debridement in sites with probing depth deeper than 5 mm

Root Instrumentation + EMD Application

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

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, 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.

    PMID: 30663788DERIVED

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 30, 2018

First Posted

June 4, 2018

Study Start

December 1, 2015

Primary Completion

January 1, 2018

Study Completion

June 1, 2018

Last Updated

July 6, 2018

Record last verified: 2018-07

Locations

IT(1)