Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2026-03-03 @ 2:18 PM
Study NCT ID:
NCT03244618
Status:
COMPLETED
Last Update Posted:
2020-10-05
First Post:
2017-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Measure the Efficacy of a Toothpaste on Dentinal Hypersensitivity
Sponsor:
Unilever R&D
Organization:
Study Overview
Official Title:
A Medical Device Study to Measure the Efficacy of a Toothpaste Containing Calcium-silicate/Phosphate on Dentinal Hypersensitivity Compared to a Control Toothpaste Containing Fluoride.
Status:
COMPLETED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Double blind parallel study to measure the efficacy of a toothpaste containing calcium-silicate/phosphate on dentinal hypersensitivity compared to a control toothpaste containing fluoride
Detailed Description:
This is a double blind parallel design, with respect to the clinical assessor and subject, study. A minimum of 280 (140 per group), male and female subjects will be recruited to ensure that a minimum of 200 subjects (100 per group) complete the study. Subjects will attend the test site on six (6) occasions.
Subjects will be screened according to the inclusion and exclusion criteria. Suitable subjects will be given a standard fluoride toothpaste and a toothbrush to use for the following four to six weeks (Run-in Phase).
On completion of the run in phase, the subjects will have a baseline sensitivity and soft tissue assessments conducted and randomised to product (visit 3).
Subjects will be randomly assigned to the test groups.
Subjects will be given sufficient supplies of their allocated toothpaste and a toothbrush to use for the following 2 weeks. Instructions for use (IFUs) will be given to the subjects along with a toothbrushing diary and an appointment to return to the test site 2 weeks (+/-1 day) later.
At the Day 14 visit, subjects will have the dentinal hypersensitivity and soft tissue assessments repeated.
Subjects will be given sufficient supplies of their allocated toothpaste and a toothbrush to use for the following 2 weeks. A fresh toothbrushing diary will be given to the subject along with an appointment to return to the test site 2 weeks later (Week 4 assessment). Subjects will be instructed to brush their teeth as per the IFU for the following 2 weeks.
At the Day 28 visit subjects will have the dentinal hypersensitivity and soft tissue assessments repeated. Prior to leaving the study site, the subjects will be asked to brush their teeth as per the IFU. Subjects will be requested to brush their teeth at a specific time and return to the study site the following day.
At the Day 29 visit, subjects will have the dentinal hypersensitivity and soft tissue assessments repeated. On completion of the assessments, subjects will receive their remuneration for the participating in the study.
Subjects will be screened according to the inclusion and exclusion criteria. Suitable subjects will be given a standard fluoride toothpaste and a toothbrush to use for the following four to six weeks (Run-in Phase).
On completion of the run in phase, the subjects will have a baseline sensitivity and soft tissue assessments conducted and randomised to product (visit 3).
Subjects will be randomly assigned to the test groups.
Subjects will be given sufficient supplies of their allocated toothpaste and a toothbrush to use for the following 2 weeks. Instructions for use (IFUs) will be given to the subjects along with a toothbrushing diary and an appointment to return to the test site 2 weeks (+/-1 day) later.
At the Day 14 visit, subjects will have the dentinal hypersensitivity and soft tissue assessments repeated.
Subjects will be given sufficient supplies of their allocated toothpaste and a toothbrush to use for the following 2 weeks. A fresh toothbrushing diary will be given to the subject along with an appointment to return to the test site 2 weeks later (Week 4 assessment). Subjects will be instructed to brush their teeth as per the IFU for the following 2 weeks.
At the Day 28 visit subjects will have the dentinal hypersensitivity and soft tissue assessments repeated. Prior to leaving the study site, the subjects will be asked to brush their teeth as per the IFU. Subjects will be requested to brush their teeth at a specific time and return to the study site the following day.
At the Day 29 visit, subjects will have the dentinal hypersensitivity and soft tissue assessments repeated. On completion of the assessments, subjects will receive their remuneration for the participating in the study.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: