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

Clinical and Patient-Centered Outcomes of Full-Mouth Ultrasonic Debridement for Periodontitis: A Randomized Controlled Trial Comparing Piezoelectric and Magnetostrictive Devices

The treatment of periodontitis requires the removal of dental biofilm through both professional mechanical plaque removal and at-home oral hygiene practices. This study aims to compare clinical and psychological outcomes following professional treatment using either piezoelectric or magnetostrictive ultrasonic devices.

Study Overview

• Status: 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 screened for eligibility criteria. A comprehensive full-mouth periodontal assessment will be conducted by a calibrated examiner to determine the severity and extent of the disease. Subsequently, patients will receive oral hygiene instructions, and group allocation will be revealed using a sealed envelope. Based on the assigned group, full-mouth ultrasonic debridement will be performed by a trained operator. Patient perceptions regarding the treatment will then be recorded. After three months, patients will return for a follow-up periodontal evaluation.

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

Contacts and Locations

• Study Contact: Name: Nicola Discepoli, DDS, MSc; Phone Number: 3395256148; Email: nicola.discepoli2@unisi.it
• Study Contact Backup: Name: Nicola Discepoli, DDS, MSc; Phone Number: 3395256148; Email: ndiscepoli@me.com

Study Locations

• Italy
  • SI
    • Siena, SI, Italy, 53100
      • Recruiting
      • AOUS
      • Contact: Nicola Discepoli, DDS, MSc; Email: nicola.discepoli2@unisi.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

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, on average 6 months
noise	vas scale (0-10) for perception of noise after treatment	through study completition, on average 6 months
vibration	vas scale (0-10) for perception of vibration after treatment	through study completition, on average 6 months

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, on average 6 months

Collaborators and Investigators

• Sponsor: University of Siena

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2025
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: March 31, 2025
• First Submitted That Met QC Criteria: April 10, 2025
• First Posted (Actual): April 18, 2025

Study Record Updates

• Last Update Posted (Estimated): September 10, 2025
• Last Update Submitted That Met QC Criteria: September 3, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: periodontitis; patient centred outcomes; magnetostrictive
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Chronic Disease; Disease Attributes; Pathological Conditions, Signs and Symptoms; Periodontitis; Chronic Periodontitis; Therapeutics; Emergency Treatment
• Other Study ID Numbers: MP001

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