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Evaluate the 10-year stability clinical, radiographic outcomes obtained with the application of the modified minimally invasive surgery to deep pockets associated with intrabony defects.
This 10-year follow-up of a randomized controlled clinical trial (Cortellini & Tonetti 2011) compares three treatment modalities in deep intrabony defects: i) a control group was treated with modified minimally invasive surgical technique alone (M-MIST, N=15); ii) a second group was treated with M-MIST combined with enamel matrix derivative (M-MIST EMD, N=15, Straumann, Switzerland); iii) a third group was treated with M-MIST+EMD plus Bone Mineral Derived Xenograph (M-MIST+EMD+BMDX, N=15, Geistlich, Switzerland) . The design of the original trial has been reported along with the one-year results and the details of randomization and allocation concealment (Cortellini & Tonetti 2011). Clinical outcomes of the three groups were longitudinally followed for 10 years. The 10-year follow-up was approved by the local ethical committee for clinical research of the Health Service of Tuscany (University Hospital of Firenze protocol ATRO2019, registration n° 15106_oss). All patients gave informed consent to participate into the clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modified minimally invasive surgery alone | Experimental | Modified minimally invasive surgery alone for access and debridement of intrabony defect. This approach maximises wound stability. No application of regenerative biomaterial. |
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| Modified minimally invasive surgery with enamel matrix derivative | Active Comparator | Modified minimally invasive surgery access and debridement of intrabony defect combined with local application of enamel matrix derivative (regenerative biomaterial) |
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| Modified minimally invasive surgery with enamel matrix derivative and bone replacement graft | Active Comparator | Modified minimally invasive surgery access and debridement of intrabony defect combined with local application of enamel matrix derivative and bone replacement graft (regenerative biomaterial) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified minimally invasive surgery | Procedure | Surgical intervention alone |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical attachment level changes | Periodontal probing to the nearest millimetre | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Probing pocket depts | Periodontal maintainability | 10 years |
| Tooth survival | Survival of treated teeth - Kaplan Mayer | 10 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pierpaolo Cortellini, MD | ATRO - ERGOPERIO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Studio Cortellini | Florence | 50132 | Italy |
No plan to share data
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Long term follow up of RCT
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Allocation concealment of surgeon until completion of common part of surgical intervention. Examiner (clinical and radiographic ) and other carers blind to allocation
|
| Modified minimally invasive surgery with enamel matrix derivative | Procedure | Surgical intervention with local application of regenerative biomaterial |
|
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| Modified minimally invasive surgery with enamel matrix derivative and bone replacement graft | Procedure | Surgical intervention with local application of regenerative biomaterial and bone replacement graft |
|
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| Complication-free survival | Survival until first episode of recurrence requiring re-treatment | 10 years |
| Cost of recurrence | Total cost of managing the regretted teeth including treatment of recurrence | 10 years |
| Radiographic bone level | Changes in level of bone supporting the tooth | 10 years |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| C092710 | emerin |
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