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

NCT05279950 — Not applicable, Unknown, 52 participants, University of Siena

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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

Registry	NCT05279950
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	52 (Estimated)
Sponsor	University of Siena (Other)
Conditions	Periodontitis, Adult
Interventions	Full-mouth ultrasonic debridement with piezoelectric device (EMS, mini piezon), Full-mouth ultrasonic debridement with magnetostrictive device (Cavitron Select, Dentsply) (Device)
Dates	start 2022-04-10 (estimated), primary completion 2022-07-10 (estimated), completion 2022-10-30 (estimated), first posted 2022-03-15, last updated 2022-03-15
Locations	1 site in Italy

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Piezoelectric	Active comparator	Device: 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
Magnetostrictive	Experimental	Device: 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.

Full-mouth ultrasonic debridement with piezoelectric device (EMS, mini piezon) (Device): 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) (Device): the use of ultrasonic oscillating tips allows supragingival and subgingival biofilm and dental calculus removal

+Outcome measures

Primary outcomes

Pain perception [through study completition, 1 year]: vas scale (0-10) for perception of pain after treatment
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

Secondary outcomes

pocket closure [through study completition, 1 year]: change of pocket probing depth (millimeter) after treatment measured with a periodontal probe

+Eligibility

Sex: All, accepts 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

+Locations (1)

Facility	City	Country	Status
AOUS	Siena	Italy