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

NCT02676440 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 222

Last updated 2018-06-08

No results posted yet for this study

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

OTHER

Treatment

F13/T38

OTHER

Comparator

M26

Sponsors & Collaborators

  • University of Bristol Dental Hospital

    collaborator OTHER

  • Unilever R&D

    lead INDUSTRY

Principal Investigators

  • Nicola X West, BDS · Bristol Dental Hospital and School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-07-03
Primary Completion
2015-12-14
Completion
2016-03-14

Countries

  • United Kingdom

Study Locations

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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 NCT02676440 on ClinicalTrials.gov