The Impact of Enamel Matrix Derivatives on Markers of Systemic Inflammation After Flapless Periodontal Therapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Pisa
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Change of C Reactive Protein (CRP) at 24 hour
Study Overview
Brief Summary
The aim of this study is to compare periodontal treatment with or without the adjunct of an enamel matrix derivative in terms of acute-phase responses in healthy patients.
Detailed Description
Patients with periodontitis will be randomly allocated to two groups. In both groups, periodontal root instrumentation will be performed. In the test group, an additional flapless application of enamel matrix derivatives will be granted for sites with pockets deeper than 5 mm.
Systemic inflammation as measured through blood testing and local parameters of periodontal health will be measured at baseline and three months after treatment completion.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Good health
- •No previous periodontal treatment
- •Presence of Periodontitis (Clinical attachment loss of at least 3 mm in 2 or more non-adjacent teeth)
- •Ability to understand the study procedures and comply with them through the length of the study
Exclusion Criteria
- •Pregnancy and breast feeding
- •Need for antibiotic treatment during periodontal therapy
- •Chronic infections
- •Systemic diseases
- •Patients who report current smoking over 20 cigarettes per day
Arms & Interventions
Root Instrumentation + EMD Application
Periodontal treatment is delivered with ultrasonic instrumentation performed with fine tips. The approach chosen is the one-stage full-mouth ultrasonic debridement in which all the treatment of diseased sites is performed within one hour.
In this group, at the end of the instrumentation enamel matrix derivatives is placed in all sites with a periodontal pocket depth deeper than 5mm.
Intervention: Root Instrumentation (Procedure)
Root Instrumentation + EMD Application
Periodontal treatment is delivered with ultrasonic instrumentation performed with fine tips. The approach chosen is the one-stage full-mouth ultrasonic debridement in which all the treatment of diseased sites is performed within one hour.
In this group, at the end of the instrumentation enamel matrix derivatives is placed in all sites with a periodontal pocket depth deeper than 5mm.
Intervention: EMD Application (Device)
Root Instrumentation
Periodontal treatment is delivered with ultrasonic instrumentation performed with fine tips. The approach chosen is the one-stage full-mouth ultrasonic debridement in which all the treatment of diseased sites is performed within one hour.
Intervention: Root Instrumentation (Procedure)
Outcomes
Primary Outcomes
Change of C Reactive Protein (CRP) at 24 hour
Time Frame: Collected at Baseline and 24 hours in order to calculate the changes
CRP analyzed though blood sampling. Unit of measure: mg/L
Secondary Outcomes
- Fibrinogen(Collected at Baseline, 24 hours and 3 months after treatment)
- LDL Cholesterol(Collected at Baseline, 24 hours and 3 months after treatment)
- HDL Cholesterol(Collected at Baseline, 24 hours and 3 months after treatment)
- D-Dimer(Collected at Baseline, 24 hours and 3 months after treatment)
- Clinical attachment level (CAL)(Measured at Baseline and 3 months after treatment)
- Percentage of sites with Pocket probing depth deeper than 3mm(Measured at Baseline and 3 months after treatment)
- Cystatin C(Collected at Baseline, 24 hours and 3 months after treatment)
- Number of sites with Pocket probing depth deeper than 3mm(Measured at Baseline and 3 months after treatment)
- Cholesterol(Collected at Baseline, 24 hours and 3 months after treatment)
- Triglyceride(Collected at Baseline, 24 hours and 3 months after treatment)
- Full-mouth plaque score (FMPS)(Measured at Baseline and 3 months after treatment)
- Recession of the gingival margin (REC)(Measured at Baseline and 3 months after treatment)
- Glucose(Baseline, 24 hours and 3 months after treatment)
- Full-mouth bleeding score (FMBS)(Measured at Baseline and 3 months after treatment)
- Number of sites with Pocket probing depth deeper than 5mm(Measured at Baseline and 3 months after treatment)
- Number of bleeding sites which measured Pocket probing depth deeper than 5mm at baseline(Measured at Baseline and 3 months after treatment)
- Pocket probing depth (PPD)(Measured at Baseline and 3 months after treatment)
- Percentage of bleeding sites which measured Pocket probing depth deeper than 5mm at baseline(Measured at Baseline and 3 months after treatment)
- C Reactive Protein (CRP) at 3 months(Collected 3 months after treatment)
- Percentage of sites with Pocket probing depth deeper than 5mm(Measured at Baseline and 3 months after treatment)
Investigators
Filippo Graziani, DDS MClinDent PhD
Professor
University of Pisa