Antimicrobial Agent for Reducing Bacteria in Aerosols and Oral Cavity
Research type
Research Study
Full title
A clinical study to evaluate the efficacy of pre-procedural and pre-surgical rinsing with an antimicrobial agent in reducing bacteria in dental aerosols and in the oral cavity
IRAS ID
165661
Contact name
Francesco D'Aiuto
Contact email
Sponsor organisation
GlaxoSmithKline Consumer Healthcare
Eudract number
2014-003222-40
Duration of Study in the UK
0 years, 11 months, 1 days
Research summary
This is a research study that uses a well known mouthrinse currently sold over the counter for the control of oral bacteria(Corsodyl containing 0.2% Chlorhexidine). Procedures carried out in the dental surgery are known to create aerosol that can carry microbes from the oral cavity. These microbes can be transferred to other individuals or settle on surfaces in the room from which they can further be transferred to others. There is also evidence that suggests antimicrobials given prior to surgical procedures may have a prophylactic effect on post surgical control of bacteria. In this study, 0.2% chlorhexidine mouthrinse will be used as a pre-procedure mouthrinse before a professional scale and polish to investigate it's antibacterial effects on bacteria contained in aerosol in the dental surgery. It will also be used pre-implant surgery to investigate it's antibacterial effects in the oral cavity during and after the surgical procedure.
The study includes a maximum of 44 individuals randomly assigned to either pre-procedural rinsing prior to receiving a standard dental scale and polish as well as pre-surgical rinsing prior to dental implant surgery or no pre-procedural rinse prior to receiving a standard dental scale and polish and use of only standard toothpaste prior to surgery. There are 6 visits that take place over up to 9 weeks. After an initial examination visit followed within 6 weeks by a dental scale and polish visit, then followed within 2 weeks by the dental implant surgery, follow-up will take place 1, 3 and 7 days after the surgery.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
14/EM/1287
Date of REC Opinion
13 Jan 2015
REC opinion
Further Information Favourable Opinion