Tooth ErosionPhase 3NCT06136754
Investigate a Varnish to Protect From Erosive Toothwear
A Phase 3 study testing Varnishes, Fluoride in people with Tooth Erosion, run by Colgate Palmolive at 1 site in United Kingdom.
Trial summary
This in-situ study will investigate on extracted teeth the protection of a re-formulated varnish containing fluoride in the same concentration as an existing approved varnish used to treat caries and erosion. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Erosion
- What is being tested?
- Varnishes, Fluoride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Apr 2022to 27 Jul 2022
- Phase
- Phase 3
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females, between 18-70 years of age
- Informed Consent Form signed and availability for the duration of the study
- Good general health (absence of any condition that, in the opinion of the Principal Investigator, might constitute a risk to the subject while participating in the study.
- Examples include heart problems, valve/hip replacements, etc);
- Willingness to provide information related to their medical history
- BEWE screen (Basic erosive wear examination) of score 2 or below (no evidence of severe tooth wear)
- Normal salivary flow
- Willingness to wear an intra-oral appliance all day as instructed except when eating and drinking.
Who cannot join
- Oral pathology, chronic disease, or a history of allergy to testing products;
- Subject using anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory medication or daily analgesics within one month prior to the start of the study or scheduled to start such intake during the course of the study;
- Subject participating in any other clinical study;
- Subject pregnant or breastfeeding;
- Subject allergic to oral care products, personal care consumer products, or their ingredients;
- Extended use of antibiotics or therapeutic mouthwash any time during the three months prior to entry into the study;
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- A medical history reporting that the subject has a current systemic or autoimmune disease, such as diabetes, lupus, etc.;
- Ongoing use of medications known to affect the gingival tissues (i.e. calcium channel blockers, phenytoin, cyclosporine);
- Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone). Pocket depth equal or greater than 4 mm
- Five or more decayed, untreated dental sites (cavities);
- Current smokers and subjects with a history of alcohol or drug abuse;
- Dental work prevents wearing of the appliance or a reported need to wear a night guard.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Clinical Study to Evaluate Efficacy of a Professionally Delivered Fluoride Varnish on Erosive Tooth Wear in an In-Situ Mode
This in-situ study will investigate on extracted teeth the protection of a re-formulated varnish containing fluoride in the same concentration as an existing approved varnish used to treat caries and erosion. Healthy volunteers without caries, periodontal disease or signs of erosive tooth wear and who give consent will be recruited to a cross-over blinded intervention. Custom mouthguards (splints) housing 8 sections of extracted human teeth will wear the appliance for 3 consecutive days and then repeat the study. Extracted teeth will be collected from patients needing tooth extraction for dental reasons. Their participation ceases when they donate the teeth. The teeth will be sterilised with hypochlorite for a minimum of 24 hrs and then sectioned and polished to form a 5mm x 5mm area of enamel and placed in the splint. The varnish, with and without fluoride, will be applied to the surface of the extracted teeth, allowed to dry, and then placed into the mouth of the healthy volunteers for 6 hours, after which, the varnish will be carefully removed. Overnight the splint and teeth will be kept in a clean and moist environment and replaced in the mouth the following day, again for 6 hours. Every 90 minutes, four times over the day, the splint will be removed and immersed in 1% citric acid pH 2.7 for 2 minutes. At the end of the day, 2 sections will be removed and tested in the laboratory for hardness. The splint will be reinserted in the mouth again for 6 hours during which it will be immersed in the acid again every 90 mins. At the end of the day the samples will be removed and measured using profilometry. A few weeks later the process will be repeated with either the fluoride or non-fluoride varnish, the order being randomly determined.
- Conditions
- Tooth Erosion
- Being tested
- Varnishes, Fluoride
- Medical subject headings
- Tooth Erosion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Varnishes, FluorideDrug
Fluoride varnish containing 5.0% NaF
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | A fluoride varnish containing 5.0% NaF w/w A fluoride free toothpaste A commercially available adult soft bristle toothbrush Receives: Drug: Varnishes, Fluoride |
| Group II | Experimental | A fluoride free varnish A fluoride free toothpaste A commercially available adult soft bristle toothbrush Receives: Drug: Varnishes, Fluoride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microhardness Measurement
On day 0 and after day 2, four polished samples will have microhardness recordings. A Knoop diamond indenter, (Struers, Duramin-1/-2) at a press load of 50 g and a press time of 15 seconds will be used for each indentation. Each sample will have 5 indentations taken 100µm apart and the values recorded on an excel spreadsheet. After day 2 the samples will be re- mounted into the splint.
Measured: day 0 & end of Day 2
Profilometry scanning
Each sample will be scanned with a non-contacting laser profilometer (NCLP) with a 655-nm confocal laser mounted on an automatic motion system (XYRIS 2000CL, Taicaan, Southampton, UK) at the end of day 3. The laser scanner is accurate and capable of detecting changes of about 1um.
Measured: at the end of Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start8 Apr 2022
- Primary completion27 Jul 2022
- Study completion27 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth ErosionStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Bartlett, Dr, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06136754
- Sponsor's protocol ID
- CRO-2021-10-ETW-VN-UK-BS
- Status last verified
- Nov 2023
- First submitted
- 3 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Clinical Study to Evaluate Efficacy of a Professionally Delivered Fluoride Varnish on Erosive Tooth Wear in an In-Situ Mode
- ClinicalTrials.gov ID
- NCT06136754
- Acronym / sponsor ID
- CRO-2021-10-ETW-VN-UK-BS
- Conditions
- Tooth Erosion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Study start
- 8 Apr 2022 (actual)
- Primary completion
- 27 Jul 2022 (actual)
- Study completion
- 27 Jul 2022 (actual)
- First posted
- 18 Nov 2023 (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 in-situ study will investigate on extracted teeth the protection of a re-formulated varnish containing fluoride in the same concentration as an existing approved varnish used to treat caries and erosion. Healthy volunteers without caries, periodontal disease or signs of erosive tooth wear and who give consent will be recruited to a cross-over blinded intervention. Custom mouthguards (splints) housing 8 sections of extracted human teeth will wear the appliance for 3 consecutive days and then repeat the study. Extracted teeth will be collected from patients needing tooth extraction for dental reasons. Their participation ceases when they donate the teeth. The teeth will be sterilised with hypochlorite for a minimum of 24 hrs and then sectioned and polished to form a 5mm x 5mm area of enamel and placed in the splint. The varnish, with and without fluoride, will be applied to the surface of the extracted teeth, allowed to dry, and then placed into the mouth of the healthy volunteers for 6 hours, after which, the varnish will be carefully removed. Overnight the splint and teeth will be kept in a clean and moist environment and replaced in the mouth the following day, again for 6 hours. Every 90 minutes, four times over the day, the splint will be removed and immersed in 1% citric acid pH 2.7 for 2 minutes. At the end of the day, 2 sections will be removed and tested in the laboratory for hardness. The splint will be reinserted in the mouth again for 6 hours during which it will be immersed in the acid again every 90 mins. At the end of the day the samples will be removed and measured using profilometry. A few weeks later the process will be repeated with either the fluoride or non-fluoride varnish, the order being randomly determined.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Drug: Varnishes, FluorideA fluoride varnish containing 5.0% NaF w/w A fluoride free toothpaste A commercially available adult soft bristle toothbrush |
| Group II | Experimental | Drug: Varnishes, FluorideA fluoride free varnish A fluoride free toothpaste A commercially available adult soft bristle toothbrush |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Males and females, between 18-70 years of age
- Informed Consent Form signed and availability for the duration of the study
- Good general health (absence of any condition that, in the opinion of the Principal Investigator, might constitute a risk to the subject while participating in the study.
- Examples include heart problems, valve/hip replacements, etc);
- Willingness to provide information related to their medical history
Key exclusion criteria (12 listed)
- Oral pathology, chronic disease, or a history of allergy to testing products;
- Subject using anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory medication or daily analgesics within one month prior to the start of the study or scheduled to start such intake during the course of the study;
- Subject participating in any other clinical study;
- Subject pregnant or breastfeeding;
- Subject allergic to oral care products, personal care consumer products, or their ingredients;
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 |
|---|---|---|
| Varnishes, FluorideFluoride varnish containing 5.0% NaF | Drug | Group I, Group II |
Primary outcome
Microhardness Measurement
Time frame: day 0 & end of Day 2
On day 0 and after day 2, four polished samples will have microhardness recordings. A Knoop diamond indenter, (Struers, Duramin-1/-2) at a press load of 50 g and a press time of 15 seconds will be used for each indentation. Each sample will have 5 indentations taken 100µm apart and the values recorded on an excel spreadsheet. After day 2 the samples will be re- mounted into the splint.
Profilometry scanning
Time frame: at the end of Day 3
Each sample will be scanned with a non-contacting laser profilometer (NCLP) with a 655-nm confocal laser mounted on an automatic motion system (XYRIS 2000CL, Taicaan, Southampton, UK) at the end of day 3. The laser scanner is accurate and capable of detecting changes of about 1um.
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 18 Nov 2023.
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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.
David Bartlett, Dr principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Varnishes, Fluoride in people with Tooth Erosion, 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 8 inclusion and 12 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 18 Nov 2023. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Microhardness Measurement (time frame: day 0 & end of Day 2). 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 18 Nov 2023.