Enamel Matrix Proteins in the Treatment of Intrabony Defects in Patients With Aggressive and Chronic Periodontitis

Summary

Approaches and objectives related to the treatment of patients with aggressive periodontitis are not markedly different compared patients with the chronic form. However, the large bone loss related to young age in this aggressive form, justify a well-founded strategy, intending to further stabilization of disease progression. For this, should make use of regenerative therapies in the advanced stages of treatment. Noteworthy is the use of proteins derived from the enamel matrix (EMD) in patients with chronic periodontitis, but there is little evidence about the effects of this material in aggressive periodontitis. Thus, the present study aims to evaluate the use of EMD in patients with aggressive periodontitis, comparing them to individuals with chronic periodontitis. Will then be selected 45 subjects, among patients with generalized chronic periodontitis (GCP) and generalized aggressive periodontitis (GAP), with one or more intra-bony defects in radiographic examination, with a minimum size of 4 mm deep and 2 mm horizontal, associated with a probing depth (PD) ≥6mm, to be treated according to the groups: GAP+OFD (n = 15) GAP patients which will receive open flap debridement; GAP+OFD/EMD (n=15) GAP patients which will receive open flap debridement and application of EMD; GCP+OFD/EMD (n=15) GCP patients which will receive open flap debridement and application of EMD. Clinical evaluations will be performed at baseline, 3, 6 months and 1 year after. At baseline, 7, 15, 45 days, 3, 6 months and 1 year after will be collect samples of gingival fluid to detect bone markers by Luminex / MAGpix technology. For the periods baseline, 3, 6 months and 1 year will be collected subgingival biofilm for the detection and quantification of periodontal pathogens by real-PCR. Will still be carried x-rays on baseline, 6 months and 1 year after, and questionnaires about patient satisfaction and perception of therapy at baseline, 7 days and 6 months. To compare the parameters evaluated, ANOVA, Tukey, chi-square, Spearman and Person tests will be used (α = 5%).

Conditions

• Aggressive Periodontitis

Interventions

BIOLOGICAL

Enamel Matrix Proteins

EMD is composed of different proteins, 90% of which are amelogenins, which has the capacity to induce processes involved in the regeneration of periodontal tissues in a manner similar to normal tissue development (48). Several clinical and animal model studies have demonstrated the use of enamel matrix-derived proteins in regenerative periodontal procedures for the formation of a new periodontium.

PROCEDURE

Open Flap Debridement

After administration of local anesthetics, full-thickness flaps will be raised in order to access all defect faces. Sulcular incisions will be performed extending to mesial and distal adjacent teeth, including the entire papilla in the flap. No relaxing incisions will be performed. All granulation tissue will then be carefully removed, and subsequently scaling and root planing will be performed. The surgical area will be irrigated with 0.9% saline and carefully inspected to ensure that all steps have been satisfactorily performed until then.

Sponsors & Collaborators

• University of Campinas, Brazil

  lead OTHER

Principal Investigators

• Ana Lívia F Santana, MD · School of Odontology of Piracicaba - Unicamp

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-02-29

Primary Completion

2018-04-30

Completion

2018-04-30

Countries

• Brazil

Study Locations