Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06358742
Status:
COMPLETED
Last Update Posted:
2024-04-11
First Post:
2024-04-05
Brief Title:
Evaluation of the Effect of Zinc Citrate Trihydrate Toothpaste on the Oral Plaque Microbiome
Sponsor:
Unilever RD
Organization:
Unilever RD
Study Overview
Official Title:
Evaluation of the Effect of Zinc Citrate Trihydrate Toothpaste on the Oral Plaque Microbiome Over a 12-week Period Compared to a Toothpaste Without Zinc Citrate Trihydrate
Status:
COMPLETED
Status Verified Date:
2023-03
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:
This study is of a double-blind randomised parallel group study Subjects will be enrolled onto the study according to the inclusionexclusion criteria After recruitment subjects will be given a fluoride toothpaste without gum care agents to use for the 4-week run-in period prior to the commencement of the test phase of the study Following the run-in period baseline supragingival plaque samples will be collected 12 hours after last brushing from the upper and lower jaws separately Subjects will then then randomly allocated to one of two products zinc citrate trihydrate ZCT toothpaste or control toothpaste according to the randomization Subjects will be instructed to use the toothpaste at home brushing twice a day for 12-weeks Supragingival plaque samples will be collected again from the upper and lower jaws after 2 6 and 12 weeks Plaque samples will then undergo metataxonomic and metatranscriptomic analyses
Detailed Description:
This study is a double-blind randomized parallel group study and will be conducted by an independent clinical research organisation Subjects will be enrolled onto the study according to the inclusionexclusion criteria After recruitment subjects will be given a fluoride toothpaste without gum care agents to use for the 4-week run-in period prior to the commencement of the test phase of the study This phase of the study is to ensure that all subjects are standardized to a fluoride only toothpaste Following the run-in period baseline supragingival plaque samples will be collected 12 hours after last brushing from the upper and lower jaws separately for metataxonomic and metatranscriptomic analysis respectively Subjects will be randomly allocated to one of two products zinc citrate trihydrate toothpastecontrol toothpaste according to the randomization schedule generated using Proc Plan procedure in SAS 94 suitable for 2-group parallel design study Subjects will be instructed to use the toothpaste at home brushing twice a day for 12-weeks Supragingival plaque samples will be collected again from the upper and lower jaws after 2 6 and 12 weeks Samples are to be collected by a single clinician across the study to ensure consistency in sample collection Note The study clinician could not collect samples at week 12 because of sickness Different clinicians collected the samples instead Data analysis showed that the week 12 samples did not match the week 0 2 and 6 samples higher levels of DNA indicative of different sample collection and hence they were excluded from the analysis
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?:
None