CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 11 enrolled
Drug / intervention
Cavitron ultrasonic surgical aspiratorprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03567161
NCT03567161N/ACompleted

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

University of Milan·interventional·Posted Jun 25, 2018·Updated Jun 25, 2018

In Brief

A clinical study evaluating Cavitron ultrasonic surgical aspirator for Periodontitis. Completed, enrolled 11 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeriodontitis
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJun 25, 2018
Enrollment StartFeb 1, 2017
Primary CompletionAug 1, 2017
Study CompletionSep 1, 2017
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 8.0 years ago

Interventions

Cavitron ultrasonic surgical aspiratorprocedure

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 .