Full Mouth Ultrasonic Debridement Carried Out Either by Piezoelectric or Magnetostrictive Device

Clinical and Patient Centred Outcome Performance of Full Mouth Ultrasonic Debridement Carried Out for the Treatment of Periodontitis Performed Either by Piezoelectric or Magnetostrictive Device. A Randomized Controlled Clinical Trial

Treatment of periodontitis requires removal of dental biofilm both through professional mechanical plaque removal and domiciliar oral hygiene procedures. This study aims to compare biometric and psychological results after professional treatment of periodontitis carried out by piezoelectric or magnetostrictive ultrasonic devices.

Study Overview

• Status: Not yet recruiting
• Conditions: Periodontitis, Adult
• Intervention / Treatment: Device: Full-mouth ultrasonic debridement with piezoelectric device (EMS, mini piezon); Device: Full-mouth ultrasonic debridement with magnetostrictive device (Cavitron Select, Dentsply)

Detailed Description

Patients diagnosed with periodontitis will be assessed for eligibility criteria. Full-mouth periodontal assessment will be performed by an examiner to detect severity and extension of the disease. Thereafter, patient will receive oral hygiene instruction and a closed envelope with patient allocation will be opened. After the allocation to the intervention group, full-mouth ultrasonic debridement will be delivered to the patient by an operator and information about patient perception will be collected. Three months later, patients will be recalled for a new periodontal assessment.

• Study Type: Interventional
• Enrollment (Anticipated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: nicola Discepoli; Phone Number: 3395256148; Email: NDISCEPOLI@ME.COM
• Study Contact Backup: Name: Nicola Discepoli; Phone Number: 0039 3395256148; Email: ndiscepoli@me.com

Study Locations

• Italy
  • Siena, Italy, 53100
    • AOUS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• >18 years
• periodontitis of stage 1 and 2
• absence of systemic chronic disease

Exclusion Criteria:

• anticoagulants treatment
• antibiotic treatment 3 months before the screening visit

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Piezoelectric; Full-mouth ultrasonic debridement will be performed with a ultrasonic tip (vibration frequence >18 kHz) powered by a piezoelectric device	Device: Full-mouth ultrasonic debridement with piezoelectric device (EMS, mini piezon); the use of ultrasonic oscillating tips allows supragingival and subgingival biofilm and dental calculus removal
Experimental: Magnetostrictive; Full-mouth ultrasonic debridement will be performed with a ultrasonic tip (vibration frequence >18 kHz) powered by a magnetostrictive device.	Device: Full-mouth ultrasonic debridement with magnetostrictive device (Cavitron Select, Dentsply); the use of ultrasonic oscillating tips allows supragingival and subgingival biofilm and dental calculus removal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain perception	vas scale (0-10) for perception of pain after treatment	through study completition, 1 year
noise	vas scale (0-10) for perception of noise after treatment	through study completition, 1 year
vibration	vas scale (0-10) for perception of vibration after treatment	through study completition, 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pocket closure	change of pocket probing depth (millimeter) after treatment measured with a periodontal probe	through study completition, 1 year

Collaborators and Investigators

• Sponsor: University of Siena

Study record dates

Study Major Dates

• Study Start (Anticipated): April 10, 2022
• Primary Completion (Anticipated): July 10, 2022
• Study Completion (Anticipated): October 30, 2022

Study Registration Dates

• First Submitted: March 4, 2020
• First Submitted That Met QC Criteria: March 3, 2022
• First Posted (Actual): March 15, 2022

Study Record Updates

• Last Update Posted (Actual): March 15, 2022
• Last Update Submitted That Met QC Criteria: March 3, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: periodontitis; patient centred outcomes; magnetostrictive
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis
• Other Study ID Numbers: MAG001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No