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

Primary Purpose

Periodontitis, Adult

Status
Not yet recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Full-mouth ultrasonic debridement with piezoelectric device (EMS, mini piezon)
Full-mouth ultrasonic debridement with magnetostrictive device (Cavitron Select, Dentsply)
Sponsored by
University of Siena
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis, Adult focused on measuring periodontitis, patient centred outcomes, magnetostrictive

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • AOUS

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Piezoelectric

Magnetostrictive

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 4, 2020
Last Updated
March 3, 2022
Sponsor
University of Siena
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1. Study Identification

Unique Protocol Identification Number
NCT05279950
Brief Title
Full Mouth Ultrasonic Debridement Carried Out Either by Piezoelectric or Magnetostrictive Device
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 10, 2022 (Anticipated)
Primary Completion Date
July 10, 2022 (Anticipated)
Study Completion Date
October 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Siena

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Adult
Keywords
periodontitis, patient centred outcomes, magnetostrictive

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Piezoelectric
Arm Type
Active Comparator
Arm Description
Full-mouth ultrasonic debridement will be performed with a ultrasonic tip (vibration frequence >18 kHz) powered by a piezoelectric device
Arm Title
Magnetostrictive
Arm Type
Experimental
Arm Description
Full-mouth ultrasonic debridement will be performed with a ultrasonic tip (vibration frequence >18 kHz) powered by a magnetostrictive device.
Intervention Type
Device
Intervention Name(s)
Full-mouth ultrasonic debridement with piezoelectric device (EMS, mini piezon)
Intervention Description
the use of ultrasonic oscillating tips allows supragingival and subgingival biofilm and dental calculus removal
Intervention Type
Device
Intervention Name(s)
Full-mouth ultrasonic debridement with magnetostrictive device (Cavitron Select, Dentsply)
Intervention Description
the use of ultrasonic oscillating tips allows supragingival and subgingival biofilm and dental calculus removal
Primary Outcome Measure Information:
Title
Pain perception
Description
vas scale (0-10) for perception of pain after treatment
Time Frame
through study completition, 1 year
Title
noise
Description
vas scale (0-10) for perception of noise after treatment
Time Frame
through study completition, 1 year
Title
vibration
Description
vas scale (0-10) for perception of vibration after treatment
Time Frame
through study completition, 1 year
Secondary Outcome Measure Information:
Title
pocket closure
Description
change of pocket probing depth (millimeter) after treatment measured with a periodontal probe
Time Frame
through study completition, 1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
nicola Discepoli
Phone
3395256148
Email
NDISCEPOLI@ME.COM
First Name & Middle Initial & Last Name or Official Title & Degree
Nicola Discepoli
Phone
0039 3395256148
Email
ndiscepoli@me.com
Facility Information:
Facility Name
AOUS
City
Siena
ZIP/Postal Code
53100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

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

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