"Re-instrumentation vs Flap Surgery"
Study Details
Study Description
Brief Summary
The ideal goal in treating periodontitis is the "periodontal disease stability" of the reduced/diminished periodontium characterized by minimal bleeding on probing (BoP), minimal pocket depth (PD) and stable clinical attachment level (CAL). (Lang 2018).
The initial non-surgical periodontal treatment is associated to PDs reduction and CALs gain (Eberhard 2008, Lang 2008). The amount of the clinical improvement depends on initial PD, smoking habits, oral hygiene and radicular tooth anatomy (Tomasi 2007). Minimal PD after the initial therapy (PD ≤4mm) and no BoP (Chapple 2018) are associated with periodontal stability, contrary PD ≥6mm and BoP scores ≥30% are risk factors for tooth loss (Clafey & Egelberg 1995, Matuliene 2008, Loos & Needleman 2020).
These observations introduce the need of an additional treatment for bleeding residual pockets. While for deep pockets associated to an infra-bony defect >=3mm the best treatment option is the regenerative approach, (Nibali, 2020) in case of shallow residual pockets with a minimal infra-bony component (<3mm), the choice could be between re-instrumentation or a flap surgery. From one side, the clinical improvement after re-instrumentation could reduce the need for surgery, although this is questionable (Baderstein 1984). Opposite, the flap surgery is more effective than non- surgical therapy in terms of CAL gain and PD reduction, even if, in sites with a PPD<6mm determines more CAL loss compared to non-surgical instrumentation. (Heitz-Mayfield 2002, Sanz- Sànchez 2020).
Tomasi et al re-instrumented poor responding sites reaching PD ≤4mm in less than 20% of the sites and an additional mean PPD reduction of 0,4mm compared to 1,8mm obtained after initial therapy. (Tomasi 2008). Similar results were reported in a trial comparing re-instrumentation and flap surgery without ostectomy/osteoplasty (Konig 2008), a second sub-gingival scaling resulted in minimal additional CAL gain. At the best of our knowledge there are no studies comparing re- instrumentation and flap surgery in residual periodontal pockets in terms of PD reduction, CAL gain and need for additional surgery.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Non surgical re-instrumentation 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. |
Procedure: Non surgical re-instrumentation
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.
|
| Active Comparator: Flap surgery 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). |
Procedure: Flap surgery
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).
|
Outcome Measures
Primary Outcome Measures
- PD Reduction [3 months after the procedure]
change in periodontal probing depth (in mm)
- PD Reduction [6 months after the procedure]
change in periodontal probing depth (in mm)
- PD Reduction [12 months after the procedure]
change in periodontal probing depth (in mm)
Secondary Outcome Measures
- CAL gain [3 months after the procedure]
change in clinical attachment level (in mm)
- CAL gain [6 months after the procedure]
change in clinical attachment level (in mm)
- CAL gain [12 months after the procedure]
change in clinical attachment level (in mm)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥18aa
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Patients with periodontal disease
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Less than 20 cigarettes/day
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No systemic antibiotic therapy in the last 3 months
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At least one interdental site showing PD≥5mm after the non surgical periodontal initial therapy. Infrabony component of the defect ≤3mm at x-ray
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Full-mouth plaque score and full-mouth bleeding score <15% at baseline (re-evaluation) measured at six sites per tooth
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No previous periodontal surgery at the experimental tooth
Exclusion Criteria:
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Connective tissue diseases
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Diabetes
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Pregnancy or lactating
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Furcation involvement
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Crowned tooth
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Severe tooth mobility (class III)
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Radiographical horizontal bone resorption exceeding the 50% of the root
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Florence | Florence | Italy | 50134 |
Sponsors and Collaborators
- University of Florence
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 18876