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

Not Applicable

• Conditions: Periodontitis, Adult
• Interventions: Device: Full-mouth ultrasonic debridement with magnetostrictive device (Cavitron Select, Dentsply); Device: Full-mouth ultrasonic debridement with piezoelectric device (EMS, mini piezon)

• Registration Number: NCT05279950
• Lead Sponsor: University of Siena

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.

Study Timeline

• Study First Submitted: 2020-03-04
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-03
• Last Update Submitted: 2022-03-03
• Study First Posted: 2022-03-15
• Last Update Posted: 2022-03-15
• Study Start: 2022-04-10
• Primary Completion: 2022-07-10
• Study Completion: 2022-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Magnetostrictive	Full-mouth ultrasonic debridement with magnetostrictive device (Cavitron Select, Dentsply)	Full-mouth ultrasonic debridement will be performed with a ultrasonic tip (vibration frequence \>18 kHz) powered by a magnetostrictive device.
Piezoelectric	Full-mouth ultrasonic debridement with piezoelectric device (EMS, mini piezon)	Full-mouth ultrasonic debridement will be performed with a ultrasonic tip (vibration frequence \>18 kHz) powered by a piezoelectric device

Primary Outcome Measures

Name	Time	Method
noise	through study completition, 1 year	vas scale (0-10) for perception of noise after treatment
vibration	through study completition, 1 year	vas scale (0-10) for perception of vibration after treatment
Pain perception	through study completition, 1 year	vas scale (0-10) for perception of pain after treatment

Secondary Outcome Measures

Name	Time	Method
pocket closure	through study completition, 1 year	change of pocket probing depth (millimeter) after treatment measured with a periodontal probe

Trial Locations

Locations (1)

AOUS; 🇮🇹 Siena, Italy