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
1 other identifier
interventional
52
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2025
CompletedStudy Start
First participant enrolled
March 31, 2025
CompletedFirst Posted
Study publicly available on registry
April 18, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2025
CompletedSeptember 10, 2025
September 1, 2025
6 months
March 31, 2025
September 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (1)
pocket closure
through study completition, on average 6 months
Study Arms (2)
Piezoelectric
ACTIVE COMPARATORFull-mouth ultrasonic debridement will be performed with a ultrasonic tip (vibration frequence \>18 kHz) powered by a piezoelectric device
Magnetostrictive
EXPERIMENTALFull-mouth ultrasonic debridement will be performed with a ultrasonic tip (vibration frequence \>18 kHz) powered by a magnetostrictive device.
Interventions
the use of ultrasonic oscillating tips allows supragingival and subgingival biofilm and dental calculus removal
the use of ultrasonic oscillating tips allows supragingival and subgingival biofilm and dental calculus removal
Eligibility Criteria
You may qualify if:
- \>18 years
- periodontitis of stage 1 and 2
- absence of systemic chronic disease
You may not qualify if:
- anticoagulants treatment
- antibiotic treatment 3 months before the screening visit
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
AOUS
Siena, SI, 53100, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
March 31, 2025
First Posted
April 18, 2025
Study Start
March 31, 2025
Primary Completion
October 1, 2025
Study Completion
October 1, 2025
Last Updated
September 10, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share