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Recruiting NCT06934291

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

No phase Interventional Periodontitis, Adult

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Full-mouth ultrasonic debridement with piezoelectric device (EMS, mini piezon), Full-mouth ultrasonic debridement with magnetostrictive device (Cavitron Select, Dentsply).
Who it may be relevant to
Registry conditions: Periodontitis, Adult. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

  • 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
  • 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

Primary outcome measures

  • Pain perception [Time frame: through study completition, on average 6 months]
  • noise [Time frame: through study completition, on average 6 months]
  • vibration [Time frame: through study completition, on average 6 months]
Secondary outcome measures (1)
  • pocket closure [Time frame: through study completition, on average 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Italy · 1 center
  • AOUS — Siena

Identifiers

NCT: NCT06934291 · MP001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗