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The aim of the present investigation will be evaluate the healing of periodontal intraosseous defects following Minimally Invasive Non Surgical Debridement (MINSD) and application of amelogenins, compared to MINSD alone.
A total of 22 patients will be enrolled, selected by inclusion and exclusion criteria and randomly divided in two groups: amelogenin (A) and no-amelogenin group (B).
The objective of the study will be compare the healing of periodontal intraosseous defects following treatment with Minimally Invasive Non Surgical Debridement (MINSD) and application of amelogenins compared to MINSD alone.
Twenty-two patients with intraosseous periodontal defects will be randomly assigned to treatment with MINSD and application of amelogenins (A Group) or MINSD alone (B Group).
Primary outcome will be "Clinical Attachment Level" (CAL) gain, while the secondary outcomes will be "Probing Depth" (PD), "Gingival Recession" (GR) and "Radiographic Defect Angle" (RDA).
After local anesthesia, in A group MINSD will be performed using an ultrasonic scaler with fine tips and micro-curette; then, amelogenins in gel will be applied in the intraosseous periodontal pockets using a sterile syringe with plasticized needle.
In the B group, only subgingival mechanical debridement (MINSD) will be performed with an ultrasonic scaler with fine tips and micro-curette.
Finally, a polishing paste will be applied to the supra-gingival level in both groups using a rubber cup. Patients of both groups will be recalled every month for professional oral hygiene and, after 6 months, all measurements will be repeated and the final evaluation will be carried out.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amelogenin Group (A) | Experimental | Amelogenins in gel will be applied in intraosseous periodontal defects, after Minimally Invasive Non Surgical Debridement (MINSD) |
|
| No-amelogenin Group (B) | Active Comparator | Only Minimally Invasive Non Surgical Debridement (MINSD) will be performed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MINSD and amelogenins | Other | After local anesthesia, MINSD will be performed using an ultrasonic scaler with fine tips and micro-curette; then, amelogenins in gel will be applied to the intraosseous periodontal pockets using a sterile syringe with plasticized needle. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Clinical Attachment Level (CAL) gain (millimeters) | Distance from the cementoenamel junction to the bottom of the pocket | baseline and 6 months after periodontal therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Probing Depth (PD) (millimeters) | Distance from the gingival margin to the bottom of the pocket | baseline and 6 months after periodontal therapy |
| Change of Gingival Recession (GR) (millimeters) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luca Ramaglia | Contact | +393476912911 | luca.ramaglia@unina.it |
| Name | Affiliation | Role |
|---|---|---|
| Luca Ramaglia | Federico II University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Naples Federico II | Recruiting | Naples | 80131 | Italy |
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| ID | Term |
|---|---|
| D016301 | Alveolar Bone Loss |
| D010514 | Periodontal Pocket |
| ID | Term |
|---|---|
| D001862 | Bone Resorption |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D055093 | Periodontal Atrophy |
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| ID | Term |
|---|---|
| D053523 | Amelogenin |
| ID | Term |
|---|---|
| D003746 | Dental Enamel Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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The study will be designed as a double-arm randomized controlled clinical trial. The intraosseous defects of subjects allocated in A group will be treated with MINSD and application of amelogenins in gel, while in B Group only MINSD will be performed. The null hypothesis of no statistically significant differences between the two modalities for the treatment of intraosseous defects will be tested.
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Only patients will be unaware of the type of treatment performed, with prior written informed consent. So, they will be divided in the two groups of study after a process of randomization
| MINSD | Other | Only subgingival mechanical debridement (MINSD) will be performed with an ultrasonic scaler with fine tips and micro-curette. |
|
Distance from gingival margin to the cementoenamel junction
| baseline and 6 months after periodontal therapy |
| Change of Radiographic Defect Angle (RDA) (grade °) | Radiographic intraosseous angle | baseline and 6 months after periodontal therapy |
| D010510 |
| Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D010518 | Periodontitis |