To assess gum health after 26 weeks toothpaste/serum use.

• Research type

  Research Study

• Full title

  A cosmetic study to measure the effect of a toothpaste containing 2% Zinc Citrate Trihydrate used in combination with a serum containing 0.2% Zinc Sulphate Heptahydrate and a standard fluoride toothpaste on gingival health over a six month period.

• IRAS ID

  181669

• Contact name

  Nicola West

• Contact email

  N.X.West@bristol.ac.uk

• Sponsor organisation

  Unilever

• Duration of Study in the UK

  0 years, 8 months, 5 days

• Research summary

  This study is a double-blind, randomised, parallel group efficacy study. Up to 240 healthy female and male participants aged over 18 years will participate. There will be two groups of up to 120 participants. Participants will be randomised to the test groups according the allocation table prepared by the Statistician.
  Participants will be enrolled on to the study according to the inclusion/exclusion criteria. After enrollment participants will have their teeth that have been allocated for assessment cleaned using a professional prophylaxis polish by the study dentist. The participants will then be provided with a standard cosmetic silica Fluoride toothpaste and a toothbrush to use at home, twice a day for up to four weeks. After this time they will return to the test site and have the baseline dental assessments. Participants will then be randomly allocated to one of the two test products which they will use at home, twice a day for the duration of the study. Dental assessments will be conducted after 13 and 26 weeks of product use at the study site.

• REC name

  South West - Central Bristol Research Ethics Committee

• REC reference

  15/SW/0145

• Date of REC Opinion

  11 Jun 2015

• REC opinion

  Favourable Opinion