Periodontal Diseases
Conditions
Brief summary
The aim of this study is to compare surgical treatment of periodontal infrabony defects with and without the adjunct of an enemal matrix derivative (EMD) in terms of acute-phase responses, in systemic healthy patients.
Interventions
PROCEDUREPeriodontal surgery
After local anesthesia injection an intrasulcular flap is designed according to minimally invasive techniques. After flap elevation, careful removal of granulation tissues from the periodontal defects is performed. Scaling and root planing of the involved dental roots is ensured and finally suture is placed.
PROCEDUREEMD application
Application of Pref-Gel for 2 minutes and then the application on Enamel Matrix Derivatives on the surgically exposed root surface
Sponsors
Institut Straumann AG
University of Pisa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
The examiner were not aware of group allocation
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Good health * No previous periodontal surgical treatment * Indication for periodontal surgery (intrabony defects to be at least 4 mm deep) * Ability to understand the study procedures and comply with them through the length of the study
Exclusion criteria
* Pregnancy, breast feeding or taking oral contraceptive (all non-drug contraceptives will be allowed) * The need for antibiotic therapy to undergo periodontal therapy * Chronic infections * Systemic diseases * Patients who report current smoking over 20 cigarettes per day or pipe or cigar
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 |
|---|---|---|
| Clinical attachment level (CAL) at deepest site | Measured at Baseline and 6 months after treatment | Changes in CAL , measured orally through clinical examination. Unit of measure: mm |
| Pocket probing depth (PPD) at deepest site | Measured at Baseline and 6 months after treatment | Changes in PPD , measured orally through clinical examination. Unit of measure: mm |
| Glucose | Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment | analyzed though blood sampling. Unit of measure: mg/dL |
| Cholesterol | Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment | analyzed though blood sampling. Unit of measure: mg/dL |
| Triglycerides | Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment | analyzed though blood sampling. Unit of measure: mg/dL |
| C Reactive Protein (CRP) | Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment | CRP analyzed though blood sampling. Unit of measure: mg/L |
| LDL Cholesterol | Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment | analyzed though blood sampling. Unit of measure: mg/dL |
| Fibrinogen | Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment | analyzed though blood sampling. Unit of measure: mg/dL |
| D-Dimer | Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment | analyzed though blood sampling. Unit of measure: mg/L |
| Cystatin C | Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment | analyzed though blood sampling. Unit of measure: mg/L |
| Recession of the gingival margin (REC) | Measured at Baseline and 6 months after treatment | Changes in REC, measured orally through clinical examination. Unit of measure: mm |
| HDL Cholesterol | Analyzed at Baseline, 24 hours, 1 week and 6 months after treatment | analyzed though blood sampling. Unit of measure: mg/dL |
Countries
Italy
Outcome results
None listed