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There are no studies comparing reinstrumentation and flap surgery for the treatment of residual periodontal pockets.
The aim of this RCT is to compare the re-instrumentation vs the flap surgery in terms of PD reduction, CAL gain, gingival recession, need of an additional surgery and pocket closure. Moreover, PROMs will be evaluated
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non surgical re-instrumentation | Experimental | The sites showing remaining pockets (PD>4mm), in the sextants allocated to re-instrumentation group, will be treated with subgingival debridement. The subgingival debridement will be performed after the administration of local oral anaesthesia (Articaine 1:100000) using a periodontal tip on ultrasonic instrument (EMS) and Gracey's curettes. |
|
| Flap surgery | Active Comparator | All the sites showing a residual pocket in a sextant allocated to surgery group will receive flap surgery. After the administration of oral local anaesthesia (Articaine 1:100000) an intrasulcular flap will be raised. In order to preserve interdental tissue the flaps will be designed accordingly the principles of papillary preservation flap. Toot root will be carefully debrided using both ultrasonic instruments and Grecey's curettes. Bone recontouring and ostectomy/osteoplasty will be avoided. Single simple sutures will be used to close the flap (Vicryl 5-0). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flap surgery | Procedure | All the sites showing a residual pocket in a sextant allocated to surgery group will receive flap surgery. After the administration of oral local anaesthesia (Articaine 1:100000) an intrasulcular flap will be raised. In order to preserve interdental tissue the flaps will be designed accordingly the principles of papillary preservation flap. Toot root will be carefully debrided using both ultrasonic instruments and Grecey's curettes. Bone recontouring and ostectomy/osteoplasty will be avoided. Single simple sutures will be used to close the flap (Vicryl 5-0). |
| Measure | Description | Time Frame |
|---|---|---|
| PD change | change in periodontal probing depth (in mm) | 3 months after the procedure |
| PD change | change in periodontal probing depth (in mm) | 6 months after the procedure |
| PD change | change in periodontal probing depth (in mm) | 12 months after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| CAL change | change in clinical attachment level (in mm) | 3 months after the procedure |
| CAL change | change in clinical attachment level (in mm) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florence | Florence | Florence | 50134 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39011585 | Derived | Barbato L, Noce D, Di Martino M, Castelluzzo W, Spoleti F, Rupe C, Nieri M, Cairo F. Non-surgical retreatment versus papillary preservation flap surgery for residual pockets: A randomized controlled trial with clinical and patient-reported outcomes. J Clin Periodontol. 2024 Oct;51(10):1277-1288. doi: 10.1111/jcpe.14047. Epub 2024 Jul 16. |
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| ID | Term |
|---|---|
| D010514 | Periodontal Pocket |
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| Non surgical re-instrumentation | Procedure | The sites showing remaining pockets (PD>4mm), in the sextants allocated to re-instrumentation group, will be treated with subgingival debridement. The subgingival debridement will be performed after the administration of local oral anaesthesia (Articaine 1:100000) using a periodontal tip on ultrasonic instrument (EMS) and Gracey's curettes. |
|
| 6 months after the procedure |
| CAL change | change in clinical attachment level (in mm) | 12 months after the procedure |