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

NCT ID: NCT05279950

Last Updated: 2022-03-15

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-10

Study Completion Date

2022-10-30

Brief Summary

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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.

Detailed Description

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Patients diagnosed with periodontitis will be assessed for eligibility criteria. Full-mouth periodontal assessment will be performed by an examiner to detect severity and extension of the disease. Thereafter, patient will receive oral hygiene instruction and a closed envelope with patient allocation will be opened. After the allocation to the intervention group, full-mouth ultrasonic debridement will be delivered to the patient by an operator and information about patient perception will be collected. Three months later, patients will be recalled for a new periodontal assessment.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Siena

OTHER

Sponsor Role lead

Responsible Party

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Nicola Discepoli

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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AOUS

Siena, , Italy

Site Status

Countries

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Italy

Central Contacts

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nicola Discepoli

Role: CONTACT

3395256148

Nicola Discepoli

Role: CONTACT

0039 3395256148

Other Identifiers

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MAG001

Identifier Type: -

Identifier Source: org_study_id

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