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

Not Applicable

Recruiting

• Conditions: Periodontitis, Adult

• Registration Number: NCT06934291
• Lead Sponsor: University of Siena

Brief Summary

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

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.

Study Timeline

• Study Start: 2025-03-31
• Study First Submitted: 2025-03-31
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-10
• Last Update Submitted: 2025-04-10
• Study First Posted: 2025-04-18
• Last Update Posted: 2025-04-18
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• 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

Primary Outcome Measures

Name	Time	Method
Pain perception	through study completition, on average 6 months	vas scale (0-10) for perception of pain after treatment
vibration	through study completition, on average 6 months	vas scale (0-10) for perception of vibration after treatment
noise	through study completition, on average 6 months	vas scale (0-10) for perception of noise after treatment

Secondary Outcome Measures

Name	Time	Method
pocket closure	through study completition, on average 6 months	change of pocket probing depth (millimeter) after treatment measured with a periodontal probe

Trial Locations

Locations (1)

AOUS; 🇮🇹 Siena, SI, Italy