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Ultrasonic Surgical Aspirator to Treat Deep Infrabony Defects (CUSA)

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ClinicalTrials.gov Identifier: NCT03567161
Recruitment Status : Completed
First Posted : June 25, 2018
Last Update Posted : June 25, 2018
Sponsor:
Information provided by (Responsible Party):
Giovanni Lodi, University of Milan

Brief 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.


Condition or disease Intervention/treatment Phase
Periodontitis Procedure: Cavitron ultrasonic surgical aspirator Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
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

Arm Intervention/treatment
Experimental: Cavitron ultrasonic surgical aspirator

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 .





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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".

  2. 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

  3. 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

  4. Adverse effects [ Time Frame: 1 day ]
    Adverse effects of patients will be recorded via questionnaire

  5. 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.

  6. 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.

  7. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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) by one of the authors
  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).

Information from the National Library of Medicine

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


Locations
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Italy
Studio Ghezzi
Settimo Milanese, Milano, Italy, 20019
Sponsors and Collaborators
University of Milan
Investigators
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Principal Investigator: Giovanni Lodi, DMD University of Milan
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Giovanni Lodi, Professor, University of Milan
ClinicalTrials.gov Identifier: NCT03567161    
Other Study ID Numbers: CUSA
First Posted: June 25, 2018    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases