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

Primary Purpose

Generalized Aggressive Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Enamel matrix derivative proteins
Open Flap debridement
Sponsored by
Universidade Estadual Paulista Júlio de Mesquita Filho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Aggressive Periodontitis focused on measuring enamel matrix derivative, proximal furcation, randomized clinical trial

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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;

Sites / Locations

  • Naira Andere

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Enamel matrix derivative proteins

Open Flap Debridement

Arm Description

Open flap debridement to enamel matrix derivative application in proximal class-II furcation.

Open flap debridement in proximal class-II furcation.

Outcomes

Primary Outcome Measures

Horizontal clinical attachment level
horizontal component of the defect

Secondary Outcome Measures

Full Information

First Posted
October 20, 2017
Last Updated
June 3, 2019
Sponsor
Universidade Estadual Paulista Júlio de Mesquita Filho
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1. Study Identification

Unique Protocol Identification Number
NCT03320135
Brief Title
EMD for Treatment of Proximal Class-II Furcation Involvements
Acronym
OFD
Official Title
Enamel Matriz Derivate for Treatment of Proximal Class II Furcation Defects: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
October 20, 2017 (Actual)
Primary Completion Date
October 20, 2018 (Actual)
Study Completion Date
May 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Estadual Paulista Júlio de Mesquita Filho

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Aggressive Periodontitis
Keywords
enamel matrix derivative, proximal furcation, randomized clinical trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enamel matrix derivative proteins
Arm Type
Active Comparator
Arm Description
Open flap debridement to enamel matrix derivative application in proximal class-II furcation.
Arm Title
Open Flap Debridement
Arm Type
Active Comparator
Arm Description
Open flap debridement in proximal class-II furcation.
Intervention Type
Procedure
Intervention Name(s)
Enamel matrix derivative proteins
Other Intervention Name(s)
Surgical therapy
Intervention Description
Open flap debridement to enamel matrix derivative to treat proximal furcation involvements.
Intervention Type
Procedure
Intervention Name(s)
Open Flap debridement
Other Intervention Name(s)
Surgical therapy
Intervention Description
Open flap debridement will be performed to decontaminate the proximal furcation involvements.
Primary Outcome Measure Information:
Title
Horizontal clinical attachment level
Description
horizontal component of the defect
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mauro M Santamaria, DDS, PhD
Organizational Affiliation
Universidade Estadual Paulista "Julio de Mesquita Filho", ICT/UNESP
Official's Role
Study Director
Facility Information:
Facility Name
Naira Andere
City
São José dos Campos
State/Province
SP
ZIP/Postal Code
12245010
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Undecided.
Citations:
PubMed Identifier
18341602
Citation
Casarin RC, Del Peloso Ribeiro E, Nociti FH Jr, Sallum AW, Sallum EA, Ambrosano GM, Casati MZ. A double-blind randomized clinical evaluation of enamel matrix derivative proteins for the treatment of proximal class-II furcation involvements. J Clin Periodontol. 2008 May;35(5):429-37. doi: 10.1111/j.1600-051X.2008.01202.x. Epub 2008 Mar 12.
Results Reference
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EMD for Treatment of Proximal Class-II Furcation Involvements

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