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

NCT03027908 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 239

Last updated 2018-06-07

No results posted yet for this study

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

OTHER

Fluoride Toothpaste 1

Toothpaste containing 1450 ppm F as Sodium Fluoride

OTHER

Fluoride Toothpaste 2

Toothpaste containing 1450 ppm F as Sodium Fluoride

Sponsors & Collaborators

  • Unilever R&D

    lead INDUSTRY

Principal Investigators

  • Nicola X West, Professor · University of Bristol

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-10-19
Primary Completion
2017-05-08
Completion
2017-05-08

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03027908 on ClinicalTrials.gov