None listed
Conditions
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) 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
Study design
Eligibility
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