NCT03027908

A Study to Measure the Effect of Two Fluoride Toothpastes on Gingival Health Over a Six Month Period

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 239 (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. A minimum of 240 healthy female and male participants aged over 18 years will participate. The participants will be randomised into two groups. Participants will be randomly assigned 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 cleaned using a professional prophylaxis polish by the study hygienist. 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

• Gingival Diseases

Interventions

Type	Name	Description
OTHER	Fluoride Toothpaste 1	Toothpaste containing 1450 ppm F as Sodium Fluoride
OTHER	Fluoride Toothpaste 2	Toothpaste containing 1450 ppm F as Sodium Fluoride

Timeline

• Start date: 2016-10-19
• Primary completion: 2017-05-08
• Completion: 2017-05-08
• First posted: 2017-01-23
• Last updated: 2018-06-07