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NCT03027908

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

Completed NA Last updated 7 June 2018
What this trial tests

NA trial testing Fluoride Toothpaste 1 in Gingival Diseases in 239 participants. Completed in 8 May 2017.

Timeline
19 October 2016
Primary endpoint
8 May 2017
8 May 2017

Quick facts

Lead sponsorUnilever R&D
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposeprevention
Enrollment239
Start date19 October 2016
Primary completion8 May 2017
Estimated completion8 May 2017

Drugs / interventions tested

Conditions studied

Sponsor

Unilever R&D — full company profile →

Who can join

18 and older, any sex, with Gingival Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Gingival Diseases

Currently open trials in the same condition.

Other Unilever R&D trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03027908.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing