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

NCT03025204 | Completed Phase 4

• 1 other identifier: 118/2015
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Regeneration Procedures; Intrabony Defects; Cronic Periodontitis

Outcome Measures

Primary Outcomes (1)

• Relative Clinical Attachment Level

  1 year

Study Arms (3)

GAP Surgical Access (GAP + OFD, 15 patients)

ACTIVE COMPARATOR

Patients diagnosed with generalized aggressive periodontitis (GAP), in which the previously selected intrabony defect will receive will receive open flap debridement.

Procedure: Open Flap Debridement

GAP Surgical Access + EMD (GAP + OFD/EMD, 15 patients)

EXPERIMENTAL

Patients with a diagnosis of generalized aggressive periodontitis (GAP), in which the previously selected intrabony defect will receive open flap debridement and, in addition, application of the EMD in the defect.

Biological: Enamel Matrix Proteins; Procedure: Open Flap Debridement

GCP Surgical Access + EMD (GCP + OFD/EMD, 15 patients)

ACTIVE COMPARATOR

Patients with a diagnosis of generalized chronic periodontitis (GCP), in which the previously selected intrabony defect will receive open flap debridement and, in addition, application of the EMD in the defect.

Biological: Enamel Matrix Proteins; Procedure: Open Flap Debridement

Interventions

Enamel Matrix Proteins BIOLOGICAL

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.

GAP Surgical Access + EMD (GAP + OFD/EMD, 15 patients); GCP Surgical Access + EMD (GCP + OFD/EMD, 15 patients)

Open Flap Debridement PROCEDURE

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.

GAP Surgical Access (GAP + OFD, 15 patients); GAP Surgical Access + EMD (GAP + OFD/EMD, 15 patients); GCP Surgical Access + EMD (GCP + OFD/EMD, 15 patients)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of generalized aggressive periodontitis (verified by the presence of periodontal pockets and radiological loss in patients under the 35 years old at the time of diagnosis); or a diagnosis of generalized chronic periodontitis (in patients over 35 years old);
• Presence of infra-osseous defect in radiographic examination with minimum dimensions of 4mm deep and 2mm of horizontal component, associated to periodontal pocket of at least 6mm of PD;
• Presence of at least 15 teeth of the oral cavity;
• To present less than 20% of plaque index and bleeding on probing after 6 weeks of initial therapy;
• Formal consent for participation in research, after explaining the risks and benefits for individual not involved in it. (Resolution No. 196 of October 1996 and the Dental Code of Professional Ethics (C.F.O.) 179/93).

You may not qualify if:

• Presence of periapical or pulpal alteration;
• Presence of systemic alteration or use of medications (6 months prior to the study) that may influence the response to periodontal treatment;
• Pregnant and lactating women;
• Smoking;
• Periodontal treatment including subgingival instrumentation in the 6 weeks prior to the study;
• Teeth with bifurcation involvement;
• Teeth with marked mobility;
• Oral pathology, chronic disease or history of allergy to any component of the study;
• Previous periodontal surgery in the region of interest.

Sponsors & Collaborators

• University of Campinas, Brazil: lead

Study Sites (1)

Piracicaba Dental School, State University of Campinas

Piracicaba, São Paulo, 13414-903, Brazil

Location

MeSH Terms

Conditions

Aggressive Periodontitis

Interventions

enamel matrix proteins

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Ana Lívia F Santana, MD

  School of Odontology of Piracicaba - Unicamp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Enilson Antonio Sallum

Study Record Dates

• First Submitted: January 16, 2017
• First Posted: January 19, 2017
• Study Start: February 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: October 11, 2018

Record last verified: 2017-01

Locations

BR (1)