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
1 other identifier
interventional
52
1 country
1
Brief Summary
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.
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 Apr 2022
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 4, 2020
CompletedFirst Posted
Study publicly available on registry
March 15, 2022
CompletedStudy Start
First participant enrolled
April 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 10, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2022
CompletedMarch 15, 2022
March 1, 2022
3 months
March 4, 2020
March 3, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (1)
pocket closure
through study completition, 1 year
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, 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
- Professor
Study Record Dates
First Submitted
March 4, 2020
First Posted
March 15, 2022
Study Start
April 10, 2022
Primary Completion
July 10, 2022
Study Completion
October 30, 2022
Last Updated
March 15, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share