Periodontal Diseases
Conditions
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.
Interventions
PROCEDURERoot Instrumentation
Instrumentation of the root surface in order to achieve debridement
DEVICEEMD Application
Application of Enamel Matrix Derivatives on the root surface after debridement in sites with probing depth deeper than 5 mm
Sponsors
Institut Straumann AG
University of Pisa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Cholesterol | 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 |
| Triglyceride | Collected at Baseline, 24 hours and 3 months after treatment | analyzed though blood sampling. Unit of measure: mg/dL |
| Fibrinogen | 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 |
| Cystatin C | Collected at Baseline, 24 hours and 3 months after treatment | analyzed though blood sampling. Unit of measure: mg/L |
| 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. |
| 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. |
| Glucose | Baseline, 24 hours and 3 months after treatment | analyzed though blood sampling. Unit of measure: mg/dL |
| Clinical attachment level (CAL) | Measured at Baseline and 3 months after treatment | Changes in CAL , measured orally through clinical examination. Unit of measure: mm |
| 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 |
| 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 |
| 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 |
| 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: % |
| 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: % |
| 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: % |
| 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 |
| C Reactive Protein (CRP) at 3 months | Collected 3 months after treatment | CRP analyzed though blood sampling. Unit of measure: mg/L |
| Pocket probing depth (PPD) | Measured at Baseline and 3 months after treatment | Changes in PPD , measured orally through clinical examination. Unit of measure: mm |
Countries
Italy
Outcome results
None listed