Clinical Efficacy of an Experimental Toothpaste [T3450515]

• Research type

  Research Study

• Full title

  Clinical Efficacy of an Experimental Toothpaste

• IRAS ID

  36829

• Contact name

  Jon S Holt

• Sponsor organisation

  GlaxoSmithKline Consumer Healthcare

• Eudract number

  2009-015914-23

• ISRCTN Number

  finished

• Research summary

  Dental plaque is a soft sticky deposit of bacteria that collects on teeth. Bacterial by-products of dental plaque can cause inflammation of the gums (gingivitis) if the plaque is not adequately removed. Although standards of oral hygiene are generally increasing, with more frequent tooth brushing, it is difficult to remove all the plaque simply by brushing, particularly from areas of the mouth which are less accessible to a toothbrush. The addition of antimicrobial ingredients to toothpaste complements the mechanical action of a toothbrush, helping to inhibit the growth of plaque bacteria. Isopropyl methyl phenol (IPMP) is used as a preservative in cosmetic products and has been shown to have antimicrobial effects in laboratory tests. Furthermore, dentifrices containing IPMP reduced the re-growth of plaque over a 4-day period in exploratory clinical studies. It is hypothesised that the antimicrobial efficacy of IPMP will help to control the levels of bacteria in the oral cavity, thereby controlling dental plaque and maintaining gingival health. The objectives of this study are thus to investigate the ability of an IPMP containing toothpaste to control dental plaque and maintain gingival health as compared to a reference dentifrice without IPMP Healthy subjects, aged at least 18 years, who currently suffer with mild to moderate gingivitis will be invited to participate in the study. Following dental prophylaxis and a 2 week period of oral hygiene instruction and weekly professional tooth cleaning to bring them to optimum gingival health, subjects will be randomly allocated one of the 2 study treatments for twice daily home tooth brushing. Efficacy (gingival inflammation, gingival bleeding, plaque levels and plaque bacteria counts) and safety (oral tolerability) assessments will be made after 12 weeks of treatment. The research is funded by GlaxoSmithKline Consumer Healthcare. Subjects will be recruited by a Contract Research Organisation based in Northwest UK.

• REC name

  East of England - Essex Research Ethics Committee

• REC reference

  09/H0301/75

• Date of REC Opinion

  24 Dec 2009

• REC opinion

  Further Information Favourable Opinion