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The primary aim of the study is to evaluate the efficacy of conservative surgery with or without papilla preservation technique in the treatment of deep residual pockets ≥ 6 mm in stage III-IV periodontitis patients after cause related therapy (step II) in terms of endpoints of therapy and other secondary outcomes at different time intervals (1, 3 and 5 years). Moreover, the study aims to evaluate the stability of the results obtained for the different surgical approaches over a 5 years follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Papilla preservation flap | Experimental | Access flap for open flap debridement using intrasulcular incisions and papilla preservation approaches to preserve the entire interdental tissues |
|
| Conventional surgery | Active Comparator | Access flap for open flap debridement using a conventional modified Widman flap procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Papilla preservation flap | Procedure | Surgical access will be obtained using modified papilla preservation techniques and when interproximal space is narrow (less than 3mm in width) incision will be made using the simplified papilla preservation flap. Both flaps buccal and lingual/palatal will be elevated in any case to allow root surface cleaning and defects debridement under direct vision. Minimally invasive flap elevation preventing to damage inter proximal tissues with the preservation of the papilla. Defects debridement with mini-curettes. Root surface debridement with ultrasonic debridement with periotip and mini-curettes. Flaps will be positioned at the pre-surgical level without any tension. Monofilament non-resorbable 5-0 e-PTFE suturing material will be used. Suturing will be performed with external vertical mattress sutures to achieve primary intention closure. |
| Measure | Description | Time Frame |
|---|---|---|
| Pocket closure | Defined as Probing pocket depth of 3 mm or less or Probing pocket depth of 4 mm with the absence of Bleeding on Probing in sites with Probing pocket depth of 6 mm or more at baseline. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Tooth Retention | Number of teeth in the treated sextant will be calculated. | 5 years |
| Number of instrumentation re-intervention | Number of instrumentation re-intervention during supportive periodontal therapy will be calculated |
| Measure | Description | Time Frame |
|---|---|---|
| Discomfort during surgery | Self reported on a 100-mm visual analog scale scale. | Immediately after surgery. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mario Aimetti, Prof. | Contact | 0116331543 | mario.aimetti@unito.it | |
| Giacomo Baima | Contact | giacomo.baima@unito.it |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| Widman flap procedure | Procedure | Surgical access will be obtained using the modified Widman flap technique. Intrasulcular incision will be done on both buccal and lingual/palatal sides without attempting to preserve the interdental tissues and interdental tissues will be removed. Both flaps buccal and lingual/palatal will be elevated at full thickness in any case to allow root surface cleaning and defects debridement under direct vision, a vertical releasing incision could be made when needed. Defects debridement with mini-curettes. Root surface debridement with ultrasonic debridement with periotip and mini-curettes. Flaps will be positioned at the level of the alveolar crest without tension. Monofilament nonresorbable 5 - 0 e/PTFE suturing material will be used. Suturing will be performed with single interrupted sutures. |
|
| 5 years |
| Mean Probing Pocket Depth changes | Defined as the mean changes in Probing pocket depth (distance in mm from the gingival margin to the bottom of the probable sulcus) at the involved sextant with respect to baseline. | 5 years |
| Mean Clinical Attachment Level changes | Defined as the mean changes in Clinical Attachment Level (distance in mm from the Cemento Enamel Junction to the bottom of the probable sulcus) at the involved sextant with respect to baseline. | 5 years |
| Mean recession changes | Defined as the changes in recession (distance in mm from Cemento Enamel Junction to the gingival margin). | 5 years |