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

NCT ID: NCT06934291

Last Updated: 2025-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-31

Study Completion Date

2025-10-31

Brief Summary

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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

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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.

Conditions

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Periodontitis, Adult

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Piezoelectric

Full-mouth ultrasonic debridement will be performed with a ultrasonic tip (vibration frequence \>18 kHz) powered by a piezoelectric device

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

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

Magnetostrictive

Full-mouth ultrasonic debridement will be performed with a ultrasonic tip (vibration frequence \>18 kHz) powered by a magnetostrictive device.

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

Interventions

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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

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Siena

OTHER

Sponsor Role lead

Responsible Party

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Nicola Discepoli

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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AOUS

Siena, SI, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Nicola Discepoli, DDS, MSc

Role: CONTACT

3395256148

Nicola Discepoli, DDS, MSc

Role: CONTACT

3395256148

Facility Contacts

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Nicola Discepoli, DDS, MSc

Role: primary

Other Identifiers

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MP001

Identifier Type: -

Identifier Source: org_study_id

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