An interventional study of Cavitron ultrasonic surgical aspirator in Periodontitis, sponsored by University of Milan. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-06-25.
Sponsored by University of Milan · Not applicable, Interventional, and Supportive care
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.
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:
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
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.
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 :
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.
1,637 studies on the registry are indexed under Periodontitis; 327 are open to participants now.
This study's enrollment of 11 is below the median of 45 across 1,191 interventional studies indexed under Periodontitis.
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Exclusion Criteria:
Patients.with periodontitis. Inclusion criteria: 1. Having received a diagnosis of chronic periodontitis (Armitage 1999) 2. Being treated by full mouth debridement, and supportive periodontal treatment (SPT) in the last year (at least three sessions) 3. Having at least one residual pocket ≥ 5 mm with and intra bony component at least ≥ 2 mm Exclusion criteria: 1. Smoking more than ten cigarettes per day 2. Pregnancy 3. 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
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 .
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
Time frame: 6 months
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".
Time frame: 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
Time frame: 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
Time frame: 1 day
Adverse effects
Adverse effects of patients will be recorded via questionnaire
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months
Plan to share: Undecided
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University of Milan