NCT04237662

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 periodontal healing in diabetic patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

January 17, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 23, 2020

Completed
11 months until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

November 4, 2020

Status Verified

November 1, 2020

Enrollment Period

2 years

First QC Date

January 17, 2020

Last Update Submit

November 3, 2020

Conditions

Periodontal Diseases

Outcome Measures

Primary Outcomes (1)

  • Pocket probing depth (PPD)

    Changes in PPD, measured orally through clinical examination. Unit of measure: mm

    Measured at Baseline and 3 months after treatment

Secondary Outcomes (11)

  • Clinical attachment level (CAL)

    Measured at Baseline and 3 months after treatment

  • Recession of the gingival margin (REC)

    Measured at Baseline and 3 months after treatment

  • Number of sites with Pocket probing depth deeper than 5mm

    Measured at Baseline and 3 months after treatment

  • Percentage of sites with Pocket probing depth deeper than 5mm

    Measured at Baseline and 3 months after treatment

  • Percentage of bleeding sites which measured Pocket probing depth deeper than 5mm at baseline

    Measured at Baseline and 3 months after treatment

  • +6 more secondary outcomes

Study Arms (2)

Test Group

EXPERIMENTAL

Root Instrumentation + Enamel Matrix Derivative 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 InstrumentationDevice: Enamel Matrix Derivative application

Control Group

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

Interventions

Root InstrumentationPROCEDURE

Instrumentation of the root surface in order to achieve debridement

Control GroupTest Group
Enamel Matrix Derivative applicationDEVICE

Enamel Matrix Derivative will be applied in the sites with at least 6 mm of pocket depths

Test Group

Eligibility Criteria

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

You may qualify if:

  • Patients diagnosed with diabetes mellitus type II and currently under treatment;
  • No previous periodontal treatment in the last 6 months;
  • 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, 56121, Italy

RECRUITING

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: 30663788BACKGROUND

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
Masking Details
Opaque envelopes
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Single-centre randomized, parallel design, clinical trial with a 3-month follow-up
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

January 17, 2020

First Posted

January 23, 2020

Study Start

January 1, 2021

Primary Completion

January 1, 2023

Study Completion

December 31, 2023

Last Updated

November 4, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)