Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:11 PM
Study NCT ID:
NCT04155658
Status:
COMPLETED
Last Update Posted:
2020-05-18
First Post:
2019-11-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Efficacy of Sodium Monofluorophosphate (SMPF) Toothpastes on Enamel Lesion Remineralisation
Sponsor:
Unilever R&D
Organization:
Study Overview
Official Title:
An in Situ Clinical Trial to Evaluate the Efficacy of a Calcium and Phosphate Enriched Sodium Monofluorophosphate Toothpaste on Enamel Lesion Remineralisation
Status:
COMPLETED
Status Verified Date:
2020-05
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, randomized, 3 group in situ study to assess effect of three toothpastes on enamel remineralization, as measured by change in integrated mineral loss (∆∆Z). The study will examine the efficacy of an experimental sodium monofluorophosphate (SMFP) toothpaste, a standard SMFP toothpaste and a negative control toothpaste with no fluoride.
Detailed Description:
Double-blind, randomized, 3 group, in situ enamel remineralisation study. This study will accept up to 60 adult subjects who meet the inclusion/exclusion criteria in anticipation that at least 50 subjects will complete the study. All 60 subjects will have two human enamel specimens (one enamel specimen type C and one enamel specimen type N) placed in their partial denture for analysis by transverse microradiography (TMR) and of those sixty subjects, a subset will have an additional two enamel specimens (type N) placed in their partial denture for TMR measurement. All enamel specimens will have been partially demineralized using lactic acid in the laboratory prior to placement in subjects' dentures.
Subjects will receive a dental prophylaxis at the start of the trial and then brush their teeth with a fluoride-free toothpaste for the following 2 to 3 days. For the washout phase between each crossover period, subjects will return to brushing with their regular toothpaste for 4 to 5 days and then receive a dental prophylaxis and brush their teeth with a fluoride-free toothpaste for the 2 to 3 days before the next test period.
During each test period, subjects will be asked to brush with their allocated toothpaste at home twice daily for 4 weeks taking care to not brush the enamel specimens. The brushing procedure will be performed at home each morning following breakfast and right before going to bed on each evening. Subjects must wear their partial denture for 24 hours a day during the test phase.
At final visit of each test period, subjects will be instructed to brush their teeth with the randomly assigned trial toothpaste. Enamel specimens will be removed from denture and transferred to analyst for laboratory analyses.
Subjects will receive a dental prophylaxis at the start of the trial and then brush their teeth with a fluoride-free toothpaste for the following 2 to 3 days. For the washout phase between each crossover period, subjects will return to brushing with their regular toothpaste for 4 to 5 days and then receive a dental prophylaxis and brush their teeth with a fluoride-free toothpaste for the 2 to 3 days before the next test period.
During each test period, subjects will be asked to brush with their allocated toothpaste at home twice daily for 4 weeks taking care to not brush the enamel specimens. The brushing procedure will be performed at home each morning following breakfast and right before going to bed on each evening. Subjects must wear their partial denture for 24 hours a day during the test phase.
At final visit of each test period, subjects will be instructed to brush their teeth with the randomly assigned trial toothpaste. Enamel specimens will be removed from denture and transferred to analyst for laboratory analyses.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: