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Clinical Trials/NCT05279950
NCT05279950
Unknown
N/A

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

University of Siena1 site in 1 country52 target enrollmentApril 10, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Periodontitis, Adult
Sponsor
University of Siena
Enrollment
52
Locations
1
Primary Endpoint
noise
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 10, 2022
End Date
October 30, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nicola Discepoli

Professor

University of Siena

Eligibility Criteria

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

Outcomes

Primary Outcomes

noise

Time Frame: through study completition, 1 year

vas scale (0-10) for perception of noise after treatment

vibration

Time Frame: through study completition, 1 year

vas scale (0-10) for perception of vibration after treatment

Pain perception

Time Frame: through study completition, 1 year

vas scale (0-10) for perception of pain after treatment

Secondary Outcomes

  • pocket closure(through study completition, 1 year)

Study Sites (1)

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