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

NCT06358742 | Completed

• 1 other identifier: ORL-GUM-2787
• Study Type: interventional
• Target: 142
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

microbiome; metatranscriptomics

Outcome Measures

Primary Outcomes (1)

• Plaque microbiome

  Speciation of plaque bacteria

  6 weeks

Study Arms (2)

ZCT toothpaste

EXPERIMENTAL

Brush with zinc citrate trihydrate toothpaste twice per day, morning and evening, for 12 weeks

Other: ZCT toothpaste

Control toothpaste

PLACEBO COMPARATOR

Brush with control toothpaste twice per day, morning and evening, for 12 weeks.

Other: Control toothpaste

Interventions

ZCT toothpaste OTHER

ZCT toothpaste

Control toothpaste OTHER

Control toothpaste

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy, adult, male/female volunteers
• Aged between 18 and 65 years old
• Willing to sign an informed consent and complete a medical history questionnaire
• Have at least 20 natural teeth including 5 teeth (excluding 3rd molars) in each quadrant
• Must be available for the duration of the study

You may not qualify if:

• The subject is an employee of Unilever or the site conducting the study
• Subjects taking part in other oral care studies for the Sponsor or any other company
• Smokers (including eCigarettes) or those who have smoked in the preceding 12 months.
• Subjects showing unwillingness, inability or lack of motivation to carry out the study procedures
• Subjects who are pregnant or nursing
• Subjects who have used mouthwashes within the 4 weeks prior to the start of the study.
• Subjects with a Modified Gingival Index score of 3 at screening
• Diabetics
• Subjects showing signs of early or untreated caries or significant periodontal disease, which in the opinion of the Study Dentist, would affect either the scientific validity of the study or, if the subject was to participate in the study, would affect their wellbeing.
• Subjects who have full or partial dentures or any oral piercings
• Subjects who have an active oral herpetic lesion or regularly suffer with oral herpetic lesions
• Subjects who regularly use medication or food supplements (including supplements which contain Zinc) in the 4 weeks prior to the start of the study, or during the study
• Known allergies to the toothpaste ingredients or to any dental materials
• Taking a course of antimicrobial medication within 4 weeks of screening or during the study
• Long term use of anti-inflammatory and/or antihistamine drugs. Intermittent use is permitted apart from 24 hours prior to the assessments

Sponsors & Collaborators

• Unilever R&D: lead
• Intertek: collaborator

MeSH Terms

Conditions

Dental Plaque

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Robert Maclure, BDS

  Intertek CRS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Toothpaste packaged in white tubes with a study label which only differentiates products with a alphanumeric code.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2024
• First Posted: April 11, 2024
• Study Start: January 10, 2017
• Primary Completion: May 19, 2017
• Study Completion: May 19, 2017
• Last Updated: April 11, 2024

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share