EMD for Treatment of Proximal Class-II Furcation Involvements (OFD)

June 3, 2019 updated by: Mauro Pedrine Santamaria, Universidade Estadual Paulista Júlio de Mesquita Filho

Enamel Matriz Derivate for Treatment of Proximal Class II Furcation Defects: a Randomized Clinical Trial

The aim of the present study is to evaluate the clinical response of proximal furcations treated with enamel matrix derivative proteins (EMD).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Proximal class-II furcation represents a challeng to periodontal therapy. Studies show that the ultrasonic non-surgical therapy doesn't work in these defects and the guided tissue regeneration therapy with membranes also demonstrates an unpredictable improvement. Therefore, enamel matrix derivative proteins (EMD) have been proposed as a periodontal regenerative procedure due to their fundamental role in cementum development.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São José dos Campos, SP, Brazil, 12245010
        • Naira Andere

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of generalized aggressive periodontitis (Armitage, 1999; American Academy of Periodontology, 2015);
  • Have undergone a first approach for periodontal treatment (full-mouth ultrasonic debridement);
  • Presence of one proximal class-II furcation presenting probing depth > 4 mm and bleeding on probing ;
  • Good general health;
  • Agree to participate in the study and sign the informed consent form (TCLE) after explaining the risks and benefits;

Exclusion Criteria:

  • Systemic problems (cardiovascular alterations, blood dyscrasias, immunodeficiency - ASA III / IV / V) that contraindicate the periodontal procedure;
  • Have used antibiotics and anti-inflammatories in the last six months;
  • Smoke ≥ 10 cigarettes/day;
  • Pregnant or lactating;
  • Chronic use of medications that may alter the response of periodontal tissues;
  • Indication of antibiotic prophylaxis for dental procedures;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Enamel matrix derivative proteins
Open flap debridement to enamel matrix derivative application in proximal class-II furcation.
Procedure: Enamel matrix derivative proteins
Open flap debridement to enamel matrix derivative to treat proximal furcation involvements.
Other Names:
  • Surgical therapy
Procedure: Open Flap debridement
Open flap debridement will be performed to decontaminate the proximal furcation involvements.
Other Names:
  • Surgical therapy
ACTIVE_COMPARATOR: Open Flap Debridement
Open flap debridement in proximal class-II furcation.
Procedure: Open Flap debridement
Open flap debridement will be performed to decontaminate the proximal furcation involvements.
Other Names:
  • Surgical therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Horizontal clinical attachment level
Time Frame: 1 year
horizontal component of the defect
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Estadual Paulista Júlio de Mesquita Filho

Investigators

  • Study Director: Mauro M Santamaria, DDS, PhD, Universidade Estadual Paulista "Julio de Mesquita Filho", ICT/UNESP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 20, 2017

Primary Completion (ACTUAL)

October 20, 2018

Study Completion (ACTUAL)

May 20, 2019

Study Registration Dates

First Submitted

October 20, 2017

First Submitted That Met QC Criteria

October 20, 2017

First Posted (ACTUAL)

October 25, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 5, 2019

Last Update Submitted That Met QC Criteria

June 3, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UEPJMF ICT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Undecided.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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