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

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ClinicalTrials.gov Identifier: NCT03025204
Recruitment Status : Completed
First Posted : January 19, 2017
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Enilson Antonio Sallum, University of Campinas, Brazil

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%).

Condition or disease Intervention/treatment Phase
Aggressive Periodontitis Biological: Enamel Matrix Proteins Procedure: Open Flap Debridement Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Enamel Matrix Proteins in the Treatment of Intrabony Defects in Patients With Aggressive and Chronic Periodontitis: Randomized Clinical Trial
Actual Study Start Date : February 2016
Actual Primary Completion Date : April 2018
Actual Study Completion Date : April 2018

Arm Intervention/treatment
Active Comparator: GAP Surgical Access (GAP + OFD, 15 patients)
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
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.

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

Active Comparator: GCP Surgical Access + EMD (GCP + OFD/EMD, 15 patients)
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
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.




Primary Outcome Measures :
  1. Relative Clinical Attachment Level [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

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.

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): NCT03025204


Locations
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Brazil
Piracicaba Dental School, State University of Campinas
Piracicaba, São Paulo, Brazil, 13414-903
Sponsors and Collaborators
University of Campinas, Brazil
Investigators
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Principal Investigator: Ana Lívia F Santana, MD FOP-UNICAMP

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Responsible Party: Enilson Antonio Sallum, Professor Enilson Antonio Sallum, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT03025204     History of Changes
Other Study ID Numbers: 118/2015
First Posted: January 19, 2017    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: January 2017
Keywords provided by Enilson Antonio Sallum, University of Campinas, Brazil:
Regeneration Procedures
Intrabony Defects
Cronic Periodontitis
Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Aggressive Periodontitis
Aggression
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Behavioral Symptoms