Clinical Study to Evaluate the Efficacy of Chlorhexidine Mouthwashes

• Research type

  Research Study

• Full title

  Clinical Study to Evaluate the Efficacy of Chlorhexidine Mouthwashes

• IRAS ID

  110395

• Contact name

  David Payne

• Sponsor organisation

  GlaxoSmithKline Consumer Healthcare

• Eudract number

  2012-002236-87

• Research summary

  Dental plaque is a soft sticky substance that forms on the teeth and comprises of bacteria. Dental plaque can cause tooth decay and gum diseases, such as gingivitis and periodontitis. In its earliest stages, periodontal disease begins as an inflammation of the gums (gingivitis). If left untreated this can progress to periodontitis, a serious form of periodontal gum disease which is one of the major causes of tooth loss. Antibacterial mouthrinses like Chlorhexidine can be added to dental regimes for additional control of plaque related to gingivitis. The aims of this study are to compare the gingival bleeding and plaque formation following 6 weeks of twice daily use of: ?½non-alcohol mouthrinse and brushing compared to brushing only ?½an alcohol containing mouthrinse and brushing compared to brushing only. The study is being conducted by GlaxoSmithKline Consumer Healthcare and will be conducted at Intertek CRS. Healthy subjects, aged 18-64 years, who currently suffer with mild to moderate gingivitis, will be invited to participate in the study. Subjects will be required to attend the following visits: ?½Visit 1- eligible subjects will be provided with a standard toothpaste and toothbrush for brushing at home until the next visit ?½Visit 2- an oral soft tissue exam will be performed followed by measurement of baseline plaque and bleeding levels. ?½Visit 3 (may be combined with visit 2) - subjects will receive a scale & polish. Saliva samples will also be collected from a sub-set of subjects. Subjects will be allocated to their study treatment regime. ?½Visit 4 (1-2 days prior to Visit 5) - the subset will attend this visit to provide saliva samples. ?½Visit 5 (Week 6)- an oral soft tissue exam will be performed followed by measurement of plaque and bleeding levels, following 6 weeks of product use.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  12/NW/0545

• Date of REC Opinion

  16 Aug 2012

• REC opinion

  Favourable Opinion