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

NCT06358742 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2024-04-11

No results posted yet for this study

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.

Conditions

  • Dental Plaque

Interventions

OTHER

ZCT toothpaste

OTHER

Control toothpaste

Sponsors & Collaborators

  • Intertek

    collaborator INDUSTRY

  • Unilever R&D

    lead INDUSTRY

Principal Investigators

  • Robert Maclure, BDS · Intertek CRS

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-10
Primary Completion
2017-05-19
Completion
2017-05-19

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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 NCT06358742 on ClinicalTrials.gov