Enamel Matrix Derivatives on Systemic Inflammation After Periodontal Therapy
- Conditions
- Periodontal Diseases
- Interventions
- Procedure: Root InstrumentationDevice: EMD Application
- Registration Number
- NCT03544931
- Lead Sponsor
- University of Pisa
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Root Instrumentation 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. Root Instrumentation + EMD Application 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. 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. Root Instrumentation + EMD Application 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.
- Primary Outcome Measures
Name Time Method Change of C Reactive Protein (CRP) at 24 hour Collected at Baseline and 24 hours in order to calculate the changes CRP analyzed though blood sampling. Unit of measure: mg/L
- Secondary Outcome Measures
Name Time Method Percentage of sites with Pocket probing depth deeper than 5mm Measured at Baseline and 3 months after treatment Changes, measured orally through clinical examination. Unit of measure: %
Pocket probing depth (PPD) Measured at Baseline and 3 months after treatment Changes in PPD , measured orally through clinical examination. Unit of measure: mm
Percentage of bleeding sites which measured Pocket probing depth deeper than 5mm at baseline Measured at Baseline and 3 months after treatment Changes , measured orally through clinical examination. Unit of measure: %
C Reactive Protein (CRP) at 3 months Collected 3 months after treatment CRP analyzed though blood sampling. Unit of measure: mg/L
Fibrinogen Collected at Baseline, 24 hours and 3 months after treatment analyzed though blood sampling. Unit of measure: mg/dL
LDL Cholesterol Collected at Baseline, 24 hours and 3 months after treatment analyzed though blood sampling. Unit of measure: mg/dL
HDL Cholesterol Collected at Baseline, 24 hours and 3 months after treatment analyzed though blood sampling. Unit of measure: mg/dL
D-Dimer Collected at Baseline, 24 hours and 3 months after treatment analyzed though blood sampling. Unit of measure: mg/L
Clinical attachment level (CAL) Measured at Baseline and 3 months after treatment Changes in CAL , measured orally through clinical examination. Unit of measure: mm
Percentage of sites with Pocket probing depth deeper than 3mm Measured at Baseline and 3 months after treatment Changes, measured orally through clinical examination. Unit of measure: %
Cystatin C Collected at Baseline, 24 hours and 3 months after treatment analyzed though blood sampling. Unit of measure: mg/L
Number of sites with Pocket probing depth deeper than 3mm Measured at Baseline and 3 months after treatment Changes, measured orally through clinical examination. Unit of measure: N
Cholesterol Collected at Baseline, 24 hours and 3 months after treatment analyzed though blood sampling. Unit of measure: mg/dL
Triglyceride Collected at Baseline, 24 hours and 3 months after treatment analyzed though blood sampling. Unit of measure: mg/dL
Full-mouth plaque score (FMPS) Measured at Baseline and 3 months after treatment Changes in Full-mouth plaque score, measuring the amount of dental plaque on the teeth orally through clinical examination. Unit of measure %. The scale ranges from 0% ( minimum value, i.e. plaque absent) to 100% ( maximum value: all areas are occupied by plaque). 0% would the ideal value. No sub-scales are included.
Recession of the gingival margin (REC) Measured at Baseline and 3 months after treatment Changes in REC, measured orally through clinical examination. Unit of measure: mm
Glucose Baseline, 24 hours and 3 months after treatment analyzed though blood sampling. Unit of measure: mg/dL
Full-mouth bleeding score (FMBS) Measured at Baseline and 3 months after treatment Changes of Full-mouth bleeding score, measuring the number of gingival areas that bleed after gingival probe passage. It is measured orally through clinical examination. Unit of measure %. The scale ranges from 0% ( minimum value, i.e. gingival inflammation is absent) to 100% ( maximum value: all gingival areas are inflamed). 0% would the ideal value. No sub-scales are included.
Number of sites with Pocket probing depth deeper than 5mm Measured at Baseline and 3 months after treatment Changes, measured orally through clinical examination. Unit of measure: N
Number of bleeding sites which measured Pocket probing depth deeper than 5mm at baseline Measured at Baseline and 3 months after treatment Changes , measured orally through clinical examination. Unit of measure: N
Trial Locations
- Locations (1)
University Hospital of Pisa
🇮🇹Pisa, Italy