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Search / Trial NCT03025204

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

Launched by UNIVERSITY OF CAMPINAS, BRAZIL · Jan 16, 2017

Trial Information

Current as of June 27, 2025

Completed

Keywords

Regeneration Procedures Intrabony Defects Cronic Periodontitis

ClinConnect Summary

General work plan and experimental methodology

1. Sample Selection

After submission and approval of this project to the Research Ethics Committee (CEP) of the Piracicaba Dental School - UNICAMP, will be selected among the patients who seek spontaneously treatment in clinics pos graduate FOP-UNICAMP (where also will be performed the clinical phase of the study), 45 patients according to the inclusion criteria
2. Sampling Calculus

The sample size required for each group was calculated considering the clinical attachment level (CAL) as the primary variable. To detect a difference of 1...

Gender

ALL

Eligibility 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.

About University Of Campinas, Brazil

The University of Campinas (Universidade Estadual de Campinas, UNICAMP) is a prestigious research institution located in Brazil, renowned for its commitment to advancing knowledge and innovation in the medical and scientific fields. With a strong emphasis on interdisciplinary collaboration, UNICAMP conducts cutting-edge clinical trials aimed at improving healthcare outcomes and developing novel therapeutic approaches. The university leverages its extensive resources, including state-of-the-art laboratories and a team of highly qualified researchers and clinicians, to contribute significantly to the global body of medical research while fostering education and training in clinical and translational sciences.

Locations

Piracicaba, São Paulo, Brazil

Piracicaba, , Brazil

Patients applied

0 patients applied

Trial Officials

Ana Lívia F Santana, MD

Principal Investigator

School of Odontology of Piracicaba - Unicamp

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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