Enamel Matrix Proteins in the Treatment of Intrabony Defects in Patients With Aggressive and Chronic Periodontitis: Randomized Clinical Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Relative Clinical Attachment Level
Study Overview
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%).
Detailed Description
General work plan and experimental methodology
- 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 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. 3. 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. 4. Study design
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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;
- •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.
Arms & Interventions
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.
Intervention: Open Flap Debridement (Procedure)
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.
Intervention: Open Flap Debridement (Procedure)
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.
Intervention: Enamel Matrix Proteins (Biological)
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.
Intervention: Enamel Matrix Proteins (Biological)
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.
Intervention: Open Flap Debridement (Procedure)
Outcomes
Primary Outcomes
Relative Clinical Attachment Level
Time Frame: 1 year
Secondary Outcomes
No secondary outcomes reported
Investigators
Enilson Antonio Sallum
Professor Enilson Antonio Sallum
University of Campinas, Brazil