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The aim of the present study is to clinically and radiographically compare the efficacy of recombinant human platelet-derived growth factor (rhPDGF), Leukocyte-Platelet Rich Fibrin (L-PRF) and Enamel Matrix Derivatives (EMD) in intrabony defects following minimally invasive non surgical peridoontal therapy (MINST).
This study will be designed as a randomized clinical trial of 12-month duration. A total of 88 patients (each with a single infrabony defect) will be recruited and randomly equally distributed into 4 groups: an experimental group treated with MINST and rhPDGF, a second group treated with MINST + L-PRF, a third group treated with MINST and EMD and and a control group treated with MINST alone.
Each defect will be treated with an ultrasonic scaler with dedicated thin tips for supra- and subgingival debridement associated with hand instrumentation under local anesthesia. Caution will be taken to preserve the stability of soft tissues. Following MINST experimental and control sites will be randomly chosen. The test sites will be treated by inserting a collagen plug soaked for at least 15 minutes in a 1.5cc solution containing hPDGF-BB. In the second group the infrabony defects will be treated with MINST and L-PRF. In the third group the infrabony defects will be treated with MINST and EMD. The control group will be treated with MINST alone.
Pre- and post-treatment clinical measurements were performed by an examiner blinded to the treatment modalities using a graded periodontal probe (HuFriedy UNC 15). Before the treatment and at 6 and 12 months post-treatment, all patients were examined by measuring the clinical attachment level, probing depth, gingival recession, full-mouth plaque score and bleeding on probing.
Standardized radiographs of selected study sites will be taken at baseline and at the 6 and 12 months follow-up visits using the long-cone technique with a customized holder and a thermoplastic occlusal reference to allow reproducible positioning. All radiographs will be analysed by a dedicated dental software (Carestream Dental LLC Atlanta, GA, USA) to make linear measurements. The defect bone level (DBL), the defect angle (DA), the intra- and suprabony components of the defect and the radiographic defect area (RDA) will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MINST+rhPDGF | Experimental | After MINST the infrabony defect will be filled with a collagen sponge soaked in rhPDGF. |
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| MINST+ L-PRF | Active Comparator | After MINST the infrabony defect will be filled with a L-PRF membrane. |
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| MINST alone | Active Comparator | MINST alone will be performed. |
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| MINST+EMD | Active Comparator | After MINST the infrabony defect will be filled with EMD gel. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SRP+rhPDGF | Procedure | The infrabony defect will be debrided with the use of fine ultrasonic tips and mini hand instruments and will be treated with the application of a collagen sponge soaked in rhPDGF. |
| Measure | Description | Time Frame |
|---|---|---|
| Defect Bone Level (DBL) | Distance between the cemento-enamel junction (CEJ) and the bottom of the defect (BD) | 12 months |
| Clinical Attachment Level (CAL) | Distance between the CEJ and the bottom of the pocket | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pocket Probing Depth (PPD) | Distance between the gingival margin and the bottom of the pocket. | 12 months |
| Gingival Recession (GR) | Distance between the CEJ and the gingival margin. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michele Paolantonio, DDS, MD | Contact | 3395204073 | michelepaolantonio@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Michele Paolantonio, DDS, MD | University 'G. D'Annunzio' of Chieti | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Medicine of Tirana | Recruiting | Tirana | Albania |
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| SRP+L-PRF | Procedure | The infrabony defect will only be debrided with the use of fine ultrasound tips and mini hand instruments and will be treated with the application of a L-PRF membrane. |
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| MINST alone | Procedure | The infrabony defect will only be debrided with the use of fine ultrasound tips and mini hand instruments and no further treatment will be performed. |
|
| MINST+EMD | Procedure | The infrabony defect will only be debrided with the use of fine ultrasound tips and mini hand instruments and will be treated with the application of EMD gel. |
|
| 12 months |
| Defect Angle (DA) | Angle between the long axis of the tooth and the interproximal wall of the infrabony defect. | 12 months |
| Radiographic Defect Area | Area of the triangle defined by: side passing through the top of the interproximal ridge and perpendicular to the long axis of the tooth, side passing through the bottom of the defect and the intersection of the previous side with the root of the tooth, side passing through the top of the ridge and the bottom of the defect. | 12 months |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D017622 | Periodontal Attachment Loss |
| D010514 | Periodontal Pocket |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D055093 | Periodontal Atrophy |
| D010518 | Periodontitis |
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