Ultrasonic Surgical Aspirator to Treat Deep Infrabony Defects

Study Overview
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Brief Summary
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The primary outcome of the present study will be assess the percentage of pocket closure and the secondary aim to evaluate the clinical performance in terms of clinical attachment level (CAL) gain, probing pocket depth (PPD) reduction and gingival recession (REC) after the use of cavitron ultrasonic surgical aspirator (CUSA) in deep infrabony defects. Patients who were previously treated with active periodontal therapy followed by one year of supportive periodontal therapy (at least three sessions) will be additionally treated by the aid of CUSA. Subjects will be reviewed at 7 days, 15 days, 1 month, 3 months and 6 months. These sessions will include supra-gingival professional mechanical plaque removal (PMPR) through the use of erythritol powder plus 14 μm. Clinical measurements of the defects and X-ray with bite block will be taken at baseline and 3 and 6 months.

Detailed Description
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This will be a Phase 2 non-controlled clinical trial performed on patients with infrabony defects to test whether the employment of CUSA for treating periodontal patients: Provides benefits in terms of a PPD reduction and CAL gain Is comfortable for patients and operators; and is free from adverse events All subjects included in the study will be consecutive periodontal patients attending a private clinic in Settimo Milanese (Milan, Italy) who will be treated by two operators with similar experience in non surgical produce who performed a specific training for CUSA on a periodontal model. The clinical procedure will be always performed in a single session. Before intervention, all cases will receive local anaesthesia with 1:100.000 mepivacaine. All residual pockets ≥ 5 mm will be treated with Ultrasonic debridement: to minimize trauma to the soft tissues, the investigators used piezo-electric devices with specific thin and delicate tips (E.M.S. Electro Medi- cal Systems S.A. Chemin de la Vuarpillière, 31 1260, Lyon Swizerland). Flapless treatment: according to the anatomy of the osseous sites, the sonotrode (Sonocare 300 by Söring GmbH, Justus-von-Liebig-Ring 2 -25451 Quickborn Germany) will be inserted both intrasulcularly and trans gingivally (smallest tip is 0,8 mm); intrasulcularly in the cases of three wall defects, and trans gingivally in cases of one to two wall defects . The stack of piezo-electric quartzes transforms the electrical energy from the generator into a longitudinal, mechanical vibration of the sonotrode tip. When the tip of the sonotrode approaches the tissue, the ultrasonic energy, as a result of the high force of acceleration and cavitation effect, separates cells from the conglomerate of tissues (fragmentation). The fragmented tissue can be aspirated as a semiliquid substance through the sonotrode hole, freeing the defect from the formation of a stable blood clot. The end point will be achieving a condition in which the infrabony defect is free from the granulation tissue. After CUSA treatment, to stimulate the formation of a stable blood clot, the use of any sub gingival rinses will be avoided. No medications will be prescribed advising the patients to use painkillers (NSAIDs) if they experience postoperative pain. Subjects will be reviewed at 7 days, 15 days, 1 month, 3 months and 6 months. These sessions will include supra-gingival professional mechanical plaque removal (PMPR) through the use of erythritol powder plus 14 μm (AIR-FLOW® MASTER -EMS). Clinical measurements of the defects and X-ray with bite block will be taken at baseline and 3 and 6 months. Outcomes : Pocket Closure proportion (PPD < 5 mm); Probing depth (PPD) reduction; CAL gain; and Gingival recession. Comfort and acceptability of the patient during and after the procedure, as measured by interviews, use of painkillers in the following three days and the visual analogue scale (VAS) after one week Comfort and convenience of the operator during the procedure, as measured by interviews at the end of the procedure; and adverse events Continuous variables will be expressed as the mean ± standard deviation (SD). Dichotomous data will be expressed as a percentage. The comparison between baseline and 6 months after flapless treatment will be performed by applying a Wilcoxon signed ranked test.

Official Title
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Ultrasonic Surgical Aspirator to Treat Deep Infrabony Defects: A New Flapless Minimally Invasive Approach

Conditions
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Periodontitis

Intervention / Treatment
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* Procedure: Cavitron ultrasonic surgical aspirator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Having received a diagnosis of chronic periodontitis (Armitage 1999) Being treated by full mouth debridement, and supportive periodontal treatment (SPT) in the last year (at least three sessions) by one of the authors Having at least one residual pocket ≥ 5 mm with and intra bony component at least ≥ 2 mm Exclusion Criteria: Smoking more than ten cigarettes per day Pregnancy Irregular compliance during SPT in the last year; and systemic conditions or therapies known to affect the healing potential of periodontal tissues (e.g., uncontrolled diabetes, oncological conditions, immunosuppressant drugs).

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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cavitron ultrasonic surgical aspirator<br>Patients.with periodontitis. Inclusion criteria: Having received a diagnosis of chronic periodontitis (Armitage 1999) Being treated by full mouth debridement, and supportive periodontal treatment (SPT) in the last year (at least three sessions) Having at least one residual pocket ≥ 5 mm with and intra bony component at least ≥ 2 mm Exclusion criteria: Smoking more than ten cigarettes per day Pregnancy Irregular compliance during SPT in the last year; and systemic conditions or therapies known to affect the healing potential of periodontal tissues (e.g., uncontrolled diabetes, oncological conditions, immunosuppressant drugs). | Procedure: Cavitron ultrasonic surgical aspirator<br>* Cavitron Ultrasonic Surgical Aspirator (CUSA) has proven to be effective in biofilm disruption and cell stimulation . The hypothesis is that the employment of CUSA for non-surgical treatment of infrabony defects thanks to its abilities to disrupt, fragment and aspirate granulation tissue, will allow the formation of larger and more stable blood clot. According to the anatomy of the osseous sites, the sonotrode (Sonocare 300 by Söring GmbH, Justus-von-Liebig-Ring 2 -25451 Quickborn Germany) will be inserted both intrasulcularly and trans gingivally (smallest tip is 0,8 mm); intrasulcularly in the cases of three wall defects, and trans gingivally in cases of one to two wall defects .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Periodontal healing - Pocket Closure proportion | Periodontal Pocket Depth (PPD) is the measured distance from the free end of the gingival margin to the bottom of the periodontal pocket. PPD will be measured with the periodontal probe in millimeter (mm) and recorded in the periodontal charting. Successful result would be the achievement of residual PPD < 5 mm | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort of the patient - Visual Analogue Scale (VAS) for pain | Comfort of the patient during and after the procedure will be measured by interviews, recording the 10 cm-long visual analogue scale (VAS) for pain, ranging from 0 to 10 cm, where is no pain 10 is the worst pain perceivable. | 1 week | 
| Comfort of the patient by interview | Comfort of the patient during and after the procedure will be measured by interviews, using of painkillers in the following three days | 1 week | 
| Comfort of the operator | Comfort of the operator during the procedure will be recorded by interviews at the end of the procedure with a questionnaire | 1 day | 
| Adverse effects | Adverse effects of patients will be recorded via questionnaire | 1 day | 
| Clinical attachment level (CAL) gain | Clinical attachment level (CAL) is the distance from the cementoenamel junction to the bottom of the periodontal pocket. CAL gain will be measured with the periodontal probe in millimeter (mm), comparing CAL baseline to post-treatment values. | 6 months | 
| Gingival recession | Gingival recession is the displacement of the marginal tissue apical to the cemento-enamel junction, thus the distance from the cementoenamel junction to the free gingival margin. Gingival recession will be measured with the periodontal probe in millimeter (mm), comparing gingival recession baseline to post-treatment values. | 6 months | 
| Periodontal Pocket Depth (PPD) reduction | Periodontal Pocket Depth (PPD) reduction will be will be measured with the periodontal probe in millimeter (mm), comparing PPD baseline to post-treatment values. | 6 months |