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A study comparing two different handpieces for dental plaque removal with an air polishing device

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623001169639
Enrollment
15
Registered
2023-11-10
Start date
2023-02-24
Completion date
2023-07-28
Last updated
2023-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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).

Interventions

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)

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.

Sponsors

Axel Spahr
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

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)

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026