Periodontitis, AdultNCT05279950
Full Mouth Ultrasonic Debridement Carried Out Either by Piezoelectric or Magnetostrictive Device
A study testing Full-mouth ultrasonic debridement with piezoelectric device (EMS, mini piezon) and Full-mouth ultrasonic debridement with magnetostrictive device (Cavitron Select, Dentsply) in people with Periodontitis, Adult, run by University of Siena at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Adult
- What is being tested?
- Full-mouth ultrasonic debridement with piezoelectric device (EMS, mini piezon) and Full-mouth ultrasonic debridement with magnetostrictive device (Cavitron Select, Dentsply)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteItaly
- Study dates
- 10 Apr 2022to 30 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- >18 years
- periodontitis of stage 1 and 2
- absence of systemic chronic disease
Who cannot join
- anticoagulants treatment
- antibiotic treatment 3 months before the screening visit
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Periodontitis, Adult
- Being tested
- Full-mouth ultrasonic debridement with piezoelectric device (EMS, mini piezon), Full-mouth ultrasonic debridement with magnetostrictive device (Cavitron Select, Dentsply)
- Keywords
- periodontitis, patient centred outcomes, magnetostrictive
- Medical subject headings
- Chronic Periodontitis, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Piezoelectric | Active comparator | Full-mouth ultrasonic debridement will be performed with a ultrasonic tip (vibration frequence >18 kHz) powered by a piezoelectric device Receives: Device: Full-mouth ultrasonic debridement with piezoelectric device (EMS, mini piezon) |
| Magnetostrictive | Experimental | Full-mouth ultrasonic debridement will be performed with a ultrasonic tip (vibration frequence >18 kHz) powered by a magnetostrictive device. Receives: Device: Full-mouth ultrasonic debridement with magnetostrictive device (Cavitron Select, Dentsply) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain perception
vas scale (0-10) for perception of pain after treatment
Measured: through study completition, 1 year
noise
vas scale (0-10) for perception of noise after treatment
Measured: through study completition, 1 year
vibration
vas scale (0-10) for perception of vibration after treatment
Measured: through study completition, 1 year
Secondary outcomes (1)
pocket closure
change of pocket probing depth (millimeter) after treatment measured with a periodontal probe
Measured: through study completition, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start10 Apr 2022 (estimated)
- Primary completion10 Jul 2022 (estimated)
- Study completion30 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontitis, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Siena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicola Discepoli, University of Siena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05279950
- Sponsor's protocol ID
- MAG001
- Status last verified
- Mar 2022
- First submitted
- 4 Mar 2020
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05279950
- Acronym / sponsor ID
- MAG001
- Conditions
- Periodontitis, Adult
- Keywords
- periodontitis, patient centred outcomes, magnetostrictive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- University of SienaUniversity, hospital or other
- Study start
- 10 Apr 2022 (estimated)
- Primary completion
- 10 Jul 2022 (estimated)
- Study completion
- 30 Oct 2022 (estimated)
- First posted
- 15 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- >18 years
- periodontitis of stage 1 and 2
- absence of systemic chronic disease
Key exclusion criteria (2 listed)
- anticoagulants treatment
- antibiotic treatment 3 months before the screening visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | Piezoelectric |
| 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 | Device | Magnetostrictive |
Primary outcome
Pain perception
Time frame: through study completition, 1 year
vas scale (0-10) for perception of pain after treatment
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
1 secondary outcome
pocket closure
Time frame: through study completition, 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Full-mouth ultrasonic debridement with piezoelectric device (EMS, mini piezon) and Full-mouth ultrasonic debridement with magnetostrictive device (Cavitron Select, Dentsply) in people with Periodontitis, Adult, run by University of Siena at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact nicola Discepoli (3395256148, NDISCEPOLI@ME.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain perception (time frame: through study completition, 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2022.