Ultrasonic Surgical Aspirator to Treat Deep Infrabony Defects (CUSA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03567161|
Recruitment Status : Completed
First Posted : June 25, 2018
Last Update Posted : June 25, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Periodontitis||Procedure: Cavitron ultrasonic surgical aspirator||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Ultrasonic Surgical Aspirator to Treat Deep Infrabony Defects: A New Flapless Minimally Invasive Approach|
|Actual Study Start Date :||February 1, 2017|
|Actual Primary Completion Date :||August 1, 2017|
|Actual Study Completion Date :||September 1, 2017|
Experimental: Cavitron ultrasonic surgical aspirator
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 [ Time Frame: 6 months ]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
- Comfort of the patient - Visual Analogue Scale (VAS) for pain [ Time Frame: 1 week ]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".
- Comfort of the patient by interview [ Time Frame: 1 week ]Comfort of the patient during and after the procedure will be measured by interviews, using of painkillers in the following three days
- Comfort of the operator [ Time Frame: 1 day ]Comfort of the operator during the procedure will be recorded by interviews at the end of the procedure with a questionnaire
- Adverse effects [ Time Frame: 1 day ]Adverse effects of patients will be recorded via questionnaire
- Clinical attachment level (CAL) gain [ Time Frame: 6 months ]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.
- Gingival recession [ Time Frame: 6 months ]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.
- Periodontal Pocket Depth (PPD) reduction [ Time Frame: 6 months ]Periodontal Pocket Depth (PPD) reduction will be will be measured with the periodontal probe in millimeter (mm), comparing PPD baseline to post-treatment values.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03567161
|Settimo Milanese, Milano, Italy, 20019|
|Principal Investigator:||Giovanni Lodi, DMD||University of Milan|