NCT02676440

Effect of a Toothpaste and Serum Compared to Standard Fluoride Toothpaste on Gingival Health Over a Six Month Period.

A Study to Measure the Effect of a Toothpaste Containing Zinc Citrate Trihydrate Used in Combination With a Serum Containing Zinc Sulphate Heptahydrate and a Standard Fluoride Toothpaste on Gingival Health Over a Six Month Period.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 222 (actual)
• Sponsor: Unilever R&D · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
OTHER	Treatment	F13/T38
OTHER	Comparator	M26

Timeline

• Start date: 2015-07-03
• Primary completion: 2015-12-14
• Completion: 2016-03-14
• First posted: 2016-02-08
• Last updated: 2018-06-08

Locations

1 site across 1 country: United Kingdom