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

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ClinicalTrials.gov Identifier: NCT03320135
Recruitment Status : Completed
First Posted : October 25, 2017
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Mauro Pedrine Santamaria, Universidade Estadual Paulista Júlio de Mesquita Filho

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

Condition or disease Intervention/treatment Phase
Generalized Aggressive Periodontitis Procedure: Enamel matrix derivative proteins Procedure: Open Flap debridement Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Enamel Matriz Derivate for Treatment of Proximal Class II Furcation Defects: a Randomized Clinical Trial
Actual Study Start Date : October 20, 2017
Actual Primary Completion Date : October 20, 2018
Actual Study Completion Date : May 20, 2019

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 Name: Surgical therapy

Procedure: Open Flap debridement
Open flap debridement will be performed to decontaminate the proximal furcation involvements.
Other Name: 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 Name: Surgical therapy




Primary Outcome Measures :
  1. Horizontal clinical attachment level [ Time Frame: 1 year ]
    horizontal component of the defect



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03320135


Locations
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Brazil
Naira Andere
São José dos Campos, SP, Brazil, 12245010
Sponsors and Collaborators
Universidade Estadual Paulista Júlio de Mesquita Filho
Investigators
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Study Director: Mauro M Santamaria, DDS, PhD Universidade Estadual Paulista "Julio de Mesquita Filho", ICT/UNESP

Publications of Results:
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Responsible Party: Mauro Pedrine Santamaria, DDS,MS,PhD, Universidade Estadual Paulista Júlio de Mesquita Filho
ClinicalTrials.gov Identifier: NCT03320135     History of Changes
Other Study ID Numbers: UEPJMF ICT
First Posted: October 25, 2017    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Undecided.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mauro Pedrine Santamaria, Universidade Estadual Paulista Júlio de Mesquita Filho:
enamel matrix derivative
proximal furcation
randomized clinical trial

Additional relevant MeSH terms:
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Periodontitis
Aggressive Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases