Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001169639
Ethics application status
Approved
Date submitted
16/10/2023
Date registered
10/11/2023
Date last updated
10/11/2023
Date data sharing statement initially provided
10/11/2023
Date results information initially provided
10/11/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study comparing two different handpieces for dental plaque removal with an air polishing device
Scientific title
An in vivo and in vitro investigation of the efficacy of biofilm removal, safety, aerosol generation comparison and patient reported comfort of a novel handpiece – the EMS Airflow® MAX compared to the conventional EMS Airflow® handpiece
Secondary ID [1] 310795 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
gingivitis 331775 0
periodontitis 331776 0
Condition category
Condition code
Oral and Gastrointestinal 328516 328516 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study is designed as a crossover study so that all enrolled patients will undergo the test intervention prior to crossing over to undergo the control intervention. Prior to receving the test intervention, all participants of the study receive a whole mouth clean for plaque and calculus removal in prior visits of the study. Participants are required to refrain from oral hygiene practices from their six anterior maxillary teeth for at least sixty hours in order to cultivate a biofilm (plaque) on these teeth which were disclosed prior to using the test intervention to remove this disclosed biofilm (plaque). The test intervention is the usage of air polishing devices in conjunction with a novel handpiece (EMS Airflow® MAX handpiece) for dental prophylaxis in healthy patients or for the treatment of gingivitis or peridontitis. This test intervention is a novel handpiece that has been released by the manufacturer of this air polishing device system (EMS) and has been reported by the manufacturer to be more efficient, produce less aerosols and be more comfortable than the conventional handpiece (control intervention) that was previously on the market. The intervention will be delivered in person by a qualified dentist who is undertaking specialty training to become a periodontist at the Sydney Dental Hospital. Only the six front upper teeth will receive the test intervention on the outer (labial) surfaces. The test intervention will be administered on one occasion only and is typically used for minutes at a time. The washout period for the study is four weeks.
Intervention code [1] 327208 0
Treatment: Devices
Comparator / control treatment
The control treatment is the usage of air polishing devices in conjunction with the conventional handpiece (EMS Airflow® handpiece) for dental prophylaxis in healthy patients or for the treatment of gingivitis or peridontitis. This treatment is administered professionally in the dental chair for the primary purpose of removing stains and biofilm and is typically used for minutes at a time. Prior to receving the control intervention, all participants of the study receive a whole mouth clean for plaque and calculus removal. Additionally there was a four week crossover period between the use of the test intervention and the control intervention. Patients are required to refrain from oral hygiene practices from their six anterior maxillary teeth for atleast sixty hours in order to cultivate a biofilm (plaque) on these teeth which were disclosed prior to use of the control intervention to remove this disclosed biofilm (plaque). The intervention will be delivered in person by a qualified dentist who is undertaking specialty training to become a periodontist at the Sydney Dental Hospital.
Control group
Active

Outcomes
Primary outcome [1] 336341 0
Cleaning efficacy measured by time taken to remove disclosed biofilm from six anterior maxillary teeth after patients have not brushed these for at least sixty hours
Timepoint [1] 336341 0
Immediately after use of the test or control intervention post-operatively
Secondary outcome [1] 427914 0
Patient centred outcomes (discomfort)
Timepoint [1] 427914 0
At the conclusion of the appointment in which the patient had the intervention
Secondary outcome [2] 428195 0
Patient centred outcome (sensitivity)
Timepoint [2] 428195 0
At the conclusion of the appointment in which the patient had the intervention
Secondary outcome [3] 428196 0
Patient centred outcome (preference of handpiece)
Timepoint [3] 428196 0
At the conclusion of the control intervention appointment when the patient has experienced both interventions

Eligibility
Key inclusion criteria
Periodontally healthy patients
Periodontally diseased patients on maintenance therapy with gingivitis or periodontitis stage 1 only
Patients who are systemically healthy (ASA class 1 or 2)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Patients below an age of 18
- Patients with a risk of endocarditis
- Patients on anti-resorptive therapy (bisphosphonates and/or Prolia)
- Use of local or systemic antibiotics within the last 6 months
- Presence of dental caries
- Patients allergic to Erythritol, CPC and/or Chlorhexidine
- Patients with a blood coagulation disorder
- Patients using anticoagulants
- Patients with liver disorders
- Patients with gastro-intestinal disorders
- Pregnancy
- Lactation
- Smokers

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
24/02/2023
Date of last participant enrolment
Anticipated
Actual
28/07/2023
Date of last data collection
Anticipated
Actual
15/09/2023
Sample size
Target
15
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 315034 0
University
Name [1] 315034 0
University of Sydney
Country [1] 315034 0
Australia
Primary sponsor type
Individual
Name
Axel Spahr
Address
University of Sydney, 2 Chalmers Street, Surry Hills, NSW, 2010
Country
Australia
Secondary sponsor category [1] 317055 0
Individual
Name [1] 317055 0
Max Fertman
Address [1] 317055 0
University of Sydney, 2 Chalmers Street, Surry Hills, NSW, 2010
Country [1] 317055 0
Australia
Secondary sponsor category [2] 317056 0
Individual
Name [2] 317056 0
Tihana Divnic-Resnik
Address [2] 317056 0
University of Sydney, 2 Chalmers Street, Surry Hills, NSW, 2010
Country [2] 317056 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313995 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 313995 0
Level 11, KGV Building Missenden Road CAMPERDOWN NSW 2050
Ethics committee country [1] 313995 0
Australia
Date submitted for ethics approval [1] 313995 0
02/08/2021
Approval date [1] 313995 0
02/09/2021
Ethics approval number [1] 313995 0
X21-0164 & 2021/ETH00857

Summary
Brief summary
Clinical, microbiological and histological studies have confirmed the safety and efficacy of air polishing devices with the use of glycine and erythritol powder for the removal of biofilm in prophylaxis and in the treatment of periodontitis and peri-implantitis (Petersilka, 2011). There appears to be minimal scientifically validated or published data in the current literature base pertaining to the novel Airflow® MAX handpiece. This study is intended to provide an initial investigation regarding the the efficacy, safety, patient reported outcomes and aerosol generation of an air polishing device used in dentistry in conjunction with a novel EMS Airflow® MAX handpiece as compared to the conventional EMS Airflow® handpiece. The hypothesis is that the EMS Airflow® MAX handpiece is as safe and efficacious as the conventional EMS Airflow® handpiece in professional prophylaxis (biofilm and stain removal).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130058 0
Prof Axel Spahr
Address 130058 0
University of Sydney, 2 Chalmers Street, Surry Hills, NSW 2010
Country 130058 0
Australia
Phone 130058 0
+61 411049514
Fax 130058 0
Email 130058 0
mfer8638@uni.sydney.edu.au
Contact person for public queries
Name 130059 0
Dr Max Fertman
Address 130059 0
University of Sydney, 2 Chalmers Street, Surry Hills, NSW 2010
Country 130059 0
Australia
Phone 130059 0
+61 424182190
Fax 130059 0
Email 130059 0
mfer8638@uni.sydney.edu.au
Contact person for scientific queries
Name 130060 0
Dr Max Fertman
Address 130060 0
University of Sydney, 2 Chalmers Street, Surry Hills, NSW 2010
Country 130060 0
Australia
Phone 130060 0
+61 424182190
Fax 130060 0
Email 130060 0
mfer8638@uni.sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.