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

Study Overview
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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.

Official Title
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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

Conditions
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Periodontitis, Adult

Intervention / Treatment
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* Device: Full-mouth ultrasonic debridement with piezoelectric device (EMS, mini piezon)
* Device: Full-mouth ultrasonic debridement with magnetostrictive device (Cavitron Select, Dentsply)


Participation Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Piezoelectric<br>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)<br>* the use of ultrasonic oscillating tips allows supragingival and subgingival biofilm and dental calculus removal<br>|
| Experimental: Magnetostrictive<br>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)<br>* the use of ultrasonic oscillating tips allows supragingival and subgingival biofilm and dental calculus removal<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain perception | vas scale (0-10) for perception of pain after treatment | through study completition, 1 year | 
| noise | vas scale (0-10) for perception of noise after treatment | through study completition, 1 year | 
| vibration | vas scale (0-10) for perception of vibration after treatment | through study completition, 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pocket closure | change of pocket probing depth (millimeter) after treatment measured with a periodontal probe | through study completition, 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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periodontitis, patient centred outcomes, magnetostrictive