Dental PlaqueNCT06358742
Evaluation of the Effect of Zinc Citrate Trihydrate Toothpaste on the Oral Plaque Microbiome
A study testing ZCT toothpaste in people with Dental Plaque, run by Unilever R&D.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque
- What is being tested?
- ZCT toothpaste
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 142 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2017to 19 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
- Subjects who have or have had a medical or oral condition which in the opinion of the study dentist would make them unsuitable for inclusion
- 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
About this study
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
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.
Read the 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
- Being tested
- ZCT toothpaste, Control toothpaste
- Keywords
- microbiome, metatranscriptomics
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZCT toothpasteOther
Control toothpasteOther
| Study group | Role | What they receive |
|---|---|---|
| ZCT toothpaste | Experimental | Brush with zinc citrate trihydrate toothpaste twice per day, morning and evening, for 12 weeks Receives: Other: ZCT toothpaste |
| Control toothpaste | Placebo comparator | Brush with control toothpaste twice per day, morning and evening, for 12 weeks. Receives: Other: Control toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque microbiome
Speciation of plaque bacteria
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start10 Jan 2017
- Primary completion19 May 2017
- Study completion19 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental PlaqueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unilever R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Intertek
- Responsible party
- Sponsor
- Investigators
- Robert Maclure, BDS, Principal investigator, Intertek CRS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06358742
- Sponsor's protocol ID
- ORL-GUM-2787
- Status last verified
- Mar 2023
- First submitted
- 5 Apr 2024
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06358742
- Acronym / sponsor ID
- ORL-GUM-2787
- Conditions
- Dental Plaque
- Keywords
- microbiome, metatranscriptomics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Collaborators
- Intertek
- Study start
- 10 Jan 2017 (actual)
- Primary completion
- 19 May 2017 (actual)
- Study completion
- 19 May 2017 (actual)
- First posted
- 11 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ZCT toothpaste | Experimental | Other: ZCT toothpasteBrush with zinc citrate trihydrate toothpaste twice per day, morning and evening, for 12 weeks |
| Control toothpaste | Placebo comparator | Other: Control toothpasteBrush with control toothpaste twice per day, morning and evening, for 12 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZCT toothpaste | Other | ZCT toothpaste |
| Control toothpaste | Other | Control toothpaste |
Primary outcome
Plaque microbiome
Time frame: 6 weeks
Speciation of plaque bacteria
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Maclure, BDS principal investigator
Intertek CRS
Questions about this trial
What is this clinical trial studying?
A study testing ZCT toothpaste in people with Dental Plaque, run by Unilever R&D.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque microbiome (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024.