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

Periodontitis, Adult Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05279950
• Other study ID #: MAG001
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 10, 2022
• Est. completion date: October 30, 2022

Study information

• Verified date: March 2022
• Source: University of Siena
• Contact: nicola Discepoli
• Phone: 3395256148
• Email: NDISCEPOLI[@]ME.COM
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 52
• Est. completion date: October 30, 2022
• Est. primary completion date: July 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis
• Periodontitis, Adult

Intervention

Device:
• 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
• 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

Locations

Country	Name	City	State
Italy	AOUS	Siena

Sponsors (1)

Lead Sponsor	Collaborator
University of Siena

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain perception	vas scale (0-10) for perception of pain after treatment	through study completition, 1 year
Primary	noise	vas scale (0-10) for perception of noise after treatment	through study completition, 1 year
Primary	vibration	vas scale (0-10) for perception of vibration after treatment	through study completition, 1 year
Secondary	pocket closure	change of pocket probing depth (millimeter) after treatment measured with a periodontal probe	through study completition, 1 year