NCT06358742

Evaluation of the Effect of Zinc Citrate Trihydrate Toothpaste on the Oral Plaque Microbiome

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 142 (actual)
• Sponsor: Unilever R&D · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study is of a double-blind, randomised, parallel group study. Subjects will be enrolled onto the study according to the inclusion/exclusion 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 inclusion/exclusion 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 toothpaste/control toothpaste) according to the randomization schedule generated using Proc Plan procedure in SAS 9.4 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).

Conditions

• Dental Plaque

Interventions

Type	Name	Description
OTHER	ZCT toothpaste
OTHER	Control toothpaste

Timeline

• Start date: 2017-01-10
• Primary completion: 2017-05-19
• Completion: 2017-05-19
• First posted: 2024-04-11
• Last updated: 2024-04-11