Clinical Trial: Enamel Matrix Proteins in the Treatment of Intrabony Defects in Patients With Aggressive and Chronic Periodontitis
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Enamel Matrix Proteins in the Treatment of Intrabony Defects in Patients With Aggressive and Chronic Periodontitis: Randomized Clinical Trial
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 evalua
Detailed Summary:
General work plan and experimental methodology
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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
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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 mm with 5% alpha between groups, considering a standard deviation of 1 mm error and 80% test power, at least 12 patients in each group will be required. Considering that some patients may be lost during follow-up, 15 patients will be included in the present study.
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Randomization and Blinding
The examiner will be blind to the treatments. This is achieved by determining that the assessments are made by a professional not involved in the treatment. The division of patients into a group should be done by lot to be an entirely random sample, with treatments being randomly distributed among patients. Brown envelopes will be used, at the time of the surgical procedure, containing information from the treatment group that was generated through a computerized system.
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Study design
Sponsor: University of Campinas, Brazil
Current Primary Outcome: Relative Clinical Attachment Level [ Time Frame: 1 year ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: University of Campinas, Brazil
Dates:
Date Received: January 16, 2017
Date Started: February 2016
Date Completion: July 2018
Last Updated: January 26, 2017
Last Verified: January 2017
