ClinicalTrials.gg
RecruitingNCT06934291Updated Sep 10, 2025

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

An interventional study of Full-mouth ultrasonic debridement with piezoelectric device (EMS, mini piezon) and Full-mouth ultrasonic debridement with magnetostrictive device (Cavitron Select, Dentsply) in Periodontitis, Adult, sponsored by University of Siena. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-09-10.

Sponsored by University of Siena · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Oct 2025, 1 year 1 month ago, but the record still lists the study as recruiting.
  • Started Mar 2025; still recruiting 1 year 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Periodontitis, Adult

Keywords

  • periodontitis
  • patient centred outcomes
  • magnetostrictive
03

In context

Chronic Periodontitis

377 studies on the registry are indexed under Chronic Periodontitis; 21 are open to participants now.

This study's planned enrollment of 52 is above the median of 46 across 307 interventional studies indexed under Chronic Periodontitis.

Browse Chronic Periodontitis studies →

Lead sponsor

University of Siena is the lead sponsor of 65 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • anticoagulants treatment
  • antibiotic treatment 3 months before the screening visit
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
52 participants (estimated)

Study arms

  • 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)

  • 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)

Interventions

  • DeviceFull-mouth ultrasonic debridement with piezoelectric device (EMS, mini piezon)

    the use of ultrasonic oscillating tips allows supragingival and subgingival biofilm and dental calculus removal

  • DeviceFull-mouth ultrasonic debridement with magnetostrictive device (Cavitron Select, Dentsply)

    the use of ultrasonic oscillating tips allows supragingival and subgingival biofilm and dental calculus removal

06

What researchers measure

Primary outcomes

  1. Pain perception

    vas scale (0-10) for perception of pain after treatment

    Time frame: through study completition, on average 6 months

  2. noise

    vas scale (0-10) for perception of noise after treatment

    Time frame: through study completition, on average 6 months

  3. vibration

    vas scale (0-10) for perception of vibration after treatment

    Time frame: through study completition, on average 6 months

Secondary outcomes

  1. pocket closure

    change of pocket probing depth (millimeter) after treatment measured with a periodontal probe

    Time frame: through study completition, on average 6 months

07

Study locations

1 of 1 sites recruiting
  • AOUS
    Siena, SI 53100, Italy
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2025 (actual). Primary completion is estimated for Oct 2025, 7 months after the start.

Of 88 non-industry interventional studies with no phase under Chronic Periodontitis, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 24. This study's planned 7 months is below that.

Counting every sponsor, half of 89 studies reached it within 15 months; a quarter within 10 and three quarters within 24.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 31, 2025
First posted
Apr 18, 2025
StartActual
Mar 31, 2025
Primary completionEst.
Oct 2025
CompletionEst.
Oct 2025
Last update
Sep 10, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06934291
Lead sponsor
University of Siena
Responsible party
Nicola Discepoli (Associate Professor, University of Siena) — Principal investigator
First posted
Apr 18, 2025
Start date
Mar 31, 2025
Primary completion
Oct 2025 (estimated)
Completion
Oct 2025 (estimated)
Last update
Sep 10, 2025

Study contacts

Nicola Discepoli, DDS, MSc
Contact
nicola.discepoli2@unisi.it
3395256148
Nicola Discepoli, DDS, MSc
Contact
ndiscepoli@me.com
3395256148

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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