Skip to main content
OpenTrials
Completed

NCT Number: NCT03320135

EMD for Treatment of Proximal Class-II Furcation Involvements

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Naira Andere

São José dos Campos, São Paulo, 12245010, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Enamel matrix derivative proteins

Procedure

Open flap debridement to enamel matrix derivative to treat proximal furcation involvements.

Other names: Surgical therapy

Open Flap debridement

Procedure

Open flap debridement will be performed to decontaminate the proximal furcation involvements.

Other names: Surgical therapy

Primary outcomes

  1. Horizontal clinical attachment level

    Time frame: 1 year

    horizontal component of the defect

Sponsors and collaborators

Lead sponsor

Universidade Estadual Paulista Júlio de Mesquita Filho

Other

Registry information

Official study title

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

Acronym: OFD

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Oct 25, 2017
Registry last updated
Jun 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.