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CompletedNCT03320135OFDUpdated Jun 5, 2019

EMD for Treatment of Proximal Class-II Furcation Involvements

An interventional study of Enamel matrix derivative proteins and Open Flap debridement in Generalized Aggressive Periodontitis, sponsored by Universidade Estadual Paulista Júlio de Mesquita Filho. Completed at 1 site in Brazil. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-05.

Sponsored by Universidade Estadual Paulista Júlio de Mesquita Filho · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Generalized Aggressive Periodontitis

Keywords

  • enamel matrix derivative
  • proximal furcation
  • randomized clinical trial
03

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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;
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
34 participants (actual)

Study arms

  • Active comparator
    Enamel matrix derivative proteins

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

    Procedure: Enamel matrix derivative proteins · Procedure: Open Flap debridement

  • Active comparator
    Open Flap Debridement

    Open flap debridement in proximal class-II furcation.

    Procedure: Open Flap debridement

Interventions

  • ProcedureEnamel matrix derivative proteins

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

    Also known as: Surgical therapy

  • ProcedureOpen Flap debridement

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

    Also known as: Surgical therapy

05

What researchers measure

Primary outcomes

  1. Horizontal clinical attachment level

    horizontal component of the defect

    Time frame: 1 year

06

Study locations

1 site
  • Naira Andere
    São José dos Campos, SP 12245010, Brazil
07

References and documents

Publications

  • 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. PubMed 18341602 ↗

Individual participant data

Plan to share: Undecided — Undecided.

08

Registry details

Key details

Study ID
NCT03320135
Lead sponsor
Universidade Estadual Paulista Júlio de Mesquita Filho
Responsible party
Mauro Pedrine Santamaria (DDS,MS,PhD, Universidade Estadual Paulista Júlio de Mesquita Filho) — Principal investigator
First posted
Oct 25, 2017
Start date
Oct 20, 2017
Primary completion
Oct 20, 2018
Completion
May 20, 2019
Last update
Jun 5, 2019

Study contacts

Mauro M Santamaria, DDS, PhD
study director · Universidade Estadual Paulista "Julio de Mesquita Filho", ICT/UNESP

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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