PlaquePhase 2NCT05138978
Metagenomic and Metatranscriptomic Analysis of Clinical Plaque Samples
A Phase 2 study testing Colgate Maximum Cavity Protection plus Sugar Acid Neutralizer and Colgate Cavity Protection in people with Plaque, run by Colgate Palmolive at 1 site in United Kingdom.
Trial summary
The objective of this study is to determine the metagenomic and metatranscriptomic analysis of clinical samples. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Plaque
- What is being tested?
- Colgate Maximum Cavity Protection plus Sugar Acid Neutralizer and Colgate Cavity Protection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Oct 2017to 17 Oct 2018
- Phase
- Phase 2
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Male and/or female subjects 16 years and above
- Minimum of 20 natural uncrowned teeth (excluding third molars) must be present
- Caries active subjects will have at least 3 active caries lesions (ICDAS score 1 - 3). Caries free control subjects will either have ICDAS score 0 or ICDAS score of 1 - 3 where the lesion is inactive.
- Available throughout entire study
- Willing to use only assigned products for oral hygiene throughout the duration of the study
- Must give written informed consent
- Must be in good general health
Who cannot join
- Unwilling or unable to sign an Informed Consent Form
- Advanced periodontal disease
- Medical condition which requires premedication prior to dental visits/procedures
- Diseases of the soft or hard oral tissues
- Orthodontic appliances that interfere with clinical assessments
- Impaired salivary function
Show all 15Show fewer
- Current use of drugs that can affect salivary flow
- Use antibiotics 3 months prior to or during this study
- Use of any arginine containing oral care products such as Colgate Sensitive Pro-Relief and Colgate Maximum Cavity Protection plus Sugar Acid Neutralizer dentifrices 3 months prior to or during this study
- Pregnant or breastfeeding
- Participate in another clinical study 1 week prior to the start of the washout period or during the study period
- Use of tobacco products
- Allergic to common dentifrice ingredients
- Allergic to amino acids
- Immune compromised individuals (HIV, AIDS, immuno-suppressive drug therapy)
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to determine the metagenomic and metatranscriptomic analysis of clinical samples.
Read the detailed description
This study is a blinded, non-randomized, crossover design. Subjects who meet the inclusion/exclusion criteria will be enrolled in the study. Following enrollment, subjects will be asked to use a washout dentifrice (#200000035883/001/000) for a minimum of 1 week. Fasting plaque will be collected at Baseline and then again at a duplicate baseline collection up to 1 week after the baseline collection. Subjects will be assigned a new dentifrice (#200000035883/001/000) to use for 12 weeks. After 12 weeks' use, fasting plaque will be collected. There will be a duplicate plaque collection up to 1 week after 12 week collection. Subjects will be given a new dentifrice (#200000040228/001/000) to use for the next 24 weeks. After 24 weeks' use, fasting plaque will be collected, and there will be a duplicate plaque collection up to 1 week after this collection.
- Conditions
- Plaque
- Being tested
- Colgate Maximum Cavity Protection plus Sugar Acid Neutralizer, Colgate Cavity Protection
- Medical subject headings
- Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colgate Maximum Cavity Protection plus Sugar Acid NeutralizerDrug
Toothpaste
Colgate Cavity ProtectionDrug
Toothpaste
| Study group | Role | What they receive |
|---|---|---|
| Colgate Maximum Cavity Protection plus Sugar Acid Neutralizer | Experimental | Toothpaste Receives: Drug: Colgate Maximum Cavity Protection plus Sugar Acid Neutralizer |
| Colgate Cavity Protection | Other | Toothpaste Receives: Drug: Colgate Cavity Protection |
What is being measured
The primary outcome is the main question the study is designed to answer.
DNA (metagenomic) sequences
The primary outcome is to collect plaque following each treatment and to assess DNA
Measured: 38 weeks
RNA (metatranscriptomic) sequences
The primary outcome is to collect plaque following each treatment and to assess RNA
Measured: 38 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start6 Oct 2017
- Primary completion17 Oct 2018
- Study completion17 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PlaqueStudies of the same condition, open and under way.
- More trials run by Colgate PalmoliveThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Each subject will be randomized.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luciana Rinaudi-Marron, DR, Study director, Colgate Palmolive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05138978
- Sponsor's protocol ID
- ERO-2015-PLA-07-RPS
- Status last verified
- Nov 2021
- First submitted
- 16 Nov 2021
- Last updated
- 1 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metagenomic and Metatranscriptomic Analysis of Clinical Plaque Samples
- ClinicalTrials.gov ID
- NCT05138978
- Acronym / sponsor ID
- ERO-2015-PLA-07-RPS
- Conditions
- Plaque
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Study start
- 6 Oct 2017 (actual)
- Primary completion
- 17 Oct 2018 (actual)
- Study completion
- 17 Oct 2018 (actual)
- First posted
- 1 Dec 2021 (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.
The objective of this study is to determine the metagenomic and metatranscriptomic analysis of clinical samples.
Detailed description
This study is a blinded, non-randomized, crossover design. Subjects who meet the inclusion/exclusion criteria will be enrolled in the study. Following enrollment, subjects will be asked to use a washout dentifrice (#200000035883/001/000) for a minimum of 1 week. Fasting plaque will be collected at Baseline and then again at a duplicate baseline collection up to 1 week after the baseline collection. Subjects will be assigned a new dentifrice (#200000035883/001/000) to use for 12 weeks. After 12 weeks' use, fasting plaque will be collected. There will be a duplicate plaque collection up to 1 week after 12 week collection. Subjects will be given a new dentifrice (#200000040228/001/000) to use for the next 24 weeks. After 24 weeks' use, fasting plaque will be collected, and there will be a duplicate plaque collection up to 1 week after this collection.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Each subject will be randomized.
| Arm | Type | Receives |
|---|---|---|
| Colgate Maximum Cavity Protection plus Sugar Acid Neutralizer | Experimental | Drug: Colgate Maximum Cavity Protection plus Sugar Acid NeutralizerToothpaste |
| Colgate Cavity Protection | Other | Drug: Colgate Cavity ProtectionToothpaste |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Male and/or female subjects 16 years and above
- Minimum of 20 natural uncrowned teeth (excluding third molars) must be present
- Caries active subjects will have at least 3 active caries lesions (ICDAS score 1 - 3). Caries free control subjects will either have ICDAS score 0 or ICDAS score of 1 - 3 where the lesion is inactive.
- Available throughout entire study
- Willing to use only assigned products for oral hygiene throughout the duration of the study
Key exclusion criteria (15 listed)
- Unwilling or unable to sign an Informed Consent Form
- Advanced periodontal disease
- Medical condition which requires premedication prior to dental visits/procedures
- Diseases of the soft or hard oral tissues
- Orthodontic appliances that interfere with clinical assessments
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 |
|---|---|---|
| Colgate Maximum Cavity Protection plus Sugar Acid NeutralizerToothpaste | Drug | Colgate Maximum Cavity Protection plus Sugar Acid Neutralizer |
| Colgate Cavity ProtectionToothpaste | Drug | Colgate Cavity Protection |
Primary outcome
DNA (metagenomic) sequences
Time frame: 38 weeks
The primary outcome is to collect plaque following each treatment and to assess DNA
RNA (metatranscriptomic) sequences
Time frame: 38 weeks
The primary outcome is to collect plaque following each treatment and to assess RNA
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 1 Dec 2021.
- Individual participant dataSharing planned: Undecided
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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.
Luciana Rinaudi-Marron, DR study director
Colgate Palmolive
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Colgate Maximum Cavity Protection plus Sugar Acid Neutralizer and Colgate Cavity Protection in people with Plaque, run by Colgate Palmolive at 1 site in United Kingdom.
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 7 inclusion and 15 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 1 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
DNA (metagenomic) sequences (time frame: 38 weeks). The study lists 2 primary outcomes in all. 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 1 Dec 2021.