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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

Tracking Information
First Submitted Date  ICMJE June 12, 2018
First Posted Date  ICMJE June 25, 2018
Last Update Posted Date June 25, 2018
Actual Study Start Date  ICMJE February 1, 2017
Actual Primary Completion Date August 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2018)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ultrasonic Surgical Aspirator to Treat Deep Infrabony Defects
Official Title  ICMJE Ultrasonic Surgical Aspirator to Treat Deep Infrabony Defects: A New Flapless Minimally Invasive Approach
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.

Detailed Description

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:

  1. Provides benefits in terms of a PPD reduction and CAL gain
  2. 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

  1. 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).
  2. 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.

  3. 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Periodontitis
Intervention  ICMJE 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 .

Study Arms  ICMJE 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).
Intervention: Procedure: Cavitron ultrasonic surgical aspirator
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 21, 2018)
11
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 1, 2017
Actual Primary Completion Date August 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03567161
Other Study ID Numbers  ICMJE CUSA
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Giovanni Lodi, University of Milan
Study Sponsor  ICMJE University of Milan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Giovanni Lodi, DMD University of Milan
PRS Account University of Milan
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP