Re-instrumentation vs Flap Surgery

Study Overview
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Brief Summary
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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

Official Title
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Re-instrumentation vs Flap Surgery in Residual Pockets: a RCT on Clinical Efficacy

Conditions
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Periodontal Pocket, Periodontitis

Intervention / Treatment
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* Procedure: Flap surgery
* Procedure: Non surgical re-instrumentation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18aa Patients with periodontal disease Less than 20 cigarettes/day No systemic antibiotic therapy in the last 3 months At least one interdental site showing PD≥5mm after the non surgical periodontal initial therapy. Infrabony component of the defect ≤3mm at x-ray Full-mouth plaque score and full-mouth bleeding score <15% at baseline (re-evaluation) measured at six sites per tooth No previous periodontal surgery at the experimental tooth Exclusion Criteria: Connective tissue diseases Diabetes Pregnancy or lactating Furcation involvement Crowned tooth Severe tooth mobility (class III) Radiographical horizontal bone resorption exceeding the 50% of the root

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non surgical re-instrumentation<br>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<br>* 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.<br>|
| Active Comparator: Flap surgery<br>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<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 6 months after the procedure | 
| CAL change | change in clinical attachment level (in mm) | 12 months after the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-surgical periodontal therapy, re-instrumentation