Ultrasonic Surgical Aspirator to Treat Deep Infrabony Defects

NCT03567161 | Completed

• 1 other identifier: CUSA
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (1)

• 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

  6 months

Secondary Outcomes (7)

• Comfort of the patient - Visual Analogue Scale (VAS) for pain

  1 week

• Comfort of the patient by interview

  1 week

• Comfort of the operator

  1 day

• Adverse effects

  1 day

• Clinical attachment level (CAL) gain

  6 months

Study Arms (1)

Cavitron ultrasonic surgical aspirator

EXPERIMENTAL

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

Interventions

Cavitron ultrasonic surgical aspirator PROCEDURE

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 .

Cavitron ultrasonic surgical aspirator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having received a diagnosis of chronic periodontitis (Armitage 1999)
• Being treated by full mouth debridement, and supportive periodontal treatment (SPT) in the last year (at least three sessions) by one of the authors
• Having at least one residual pocket ≥ 5 mm with and intra bony component at least ≥ 2 mm

You may not qualify if:

• Smoking more than ten cigarettes per day
• Pregnancy
• 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).

Sponsors & Collaborators

• University of Milan: lead

Study Sites (1)

Studio Ghezzi

Settimo Milanese, Milano, 20019, Italy

Location

Related Publications (5)

• Nibali L. Intrabony defects and non-surgical treatment. Prim Dent J. 2014 Aug;3(3):48-50. doi: 10.1308/205016814812736682.

  PMID: 25198639 BACKGROUND

• Heitz-Mayfield LJ. How effective is surgical therapy compared with nonsurgical debridement? Periodontol 2000. 2005;37:72-87. doi: 10.1111/j.1600-0757.2004.03797.x. No abstract available.

  PMID: 15655026 BACKGROUND

• El Moghazy WM, Hedaya MS, Kaido T, Egawa H, Uemoto S, Takada Y. Two different methods for donor hepatic transection: cavitron ultrasonic surgical aspirator with bipolar cautery versus cavitron ultrasonic surgical aspirator with radiofrequency coagulator-A randomized controlled trial. Liver Transpl. 2009 Jan;15(1):102-5. doi: 10.1002/lt.21658.

  PMID: 19109835 BACKGROUND

• Brendan J. O'Dalya,b, Edmund Morrisb, Graham P. Gavinc, John M. O'Byrnea, Garrett B. McGuinnessb. High-power low-frequency ultrasound: A review of tissue dissection and ablation in medicine and surgery. Journal of Materials Processing Technology. Volume 200, Issues 1-3, Pages 38-58. 8 May 2008.

  BACKGROUND

• Ghezzi C, Donghi C, Ferrantino L, Varoni E, Lodi G. Ultrasonic Surgical Aspirator to Treat Deep Infrabony Defects: A New Flapless Minimally Invasive Approach. Adv Med. 2018 Jul 29;2018:3612359. doi: 10.1155/2018/3612359. eCollection 2018.

  PMID: 30155496 DERIVED

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Giovanni Lodi, DMD

  University of Milan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 12, 2018
• First Posted: June 25, 2018
• Study Start: February 1, 2017
• Primary Completion: August 1, 2017
• Study Completion: September 1, 2017
• Last Updated: June 25, 2018

Record last verified: 2018-06

Locations

IT (1)