Dental CariesNCT02436473
Clinical Efficacy of Fluoride Toothpastes Using an In Situ Caries Model
A study testing Toothpaste containing 1150ppm F, Toothpaste containing 0ppm F and Toothpaste containing 250ppm F in people with Dental Caries, run by GlaxoSmithKline.
Trial summary
The purpose of this study is to evaluate the effect of the test toothpaste containing 1150 parts per million (ppm) of fluoride (F) on the mineral content of demineralized enamel specimens, in an in situ caries model system, by comparing the differences in net remineralization change (ΔM) following use of the test… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Toothpaste containing 1150ppm F, Toothpaste containing 0ppm F and Toothpaste containing 250ppm F
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Nov 2016
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Demonstrates understanding of the study.
- Aged 18 to 85 years.
- Understands and is willing, able and likely to comply with all study procedures and restrictions.
- Has good general health (in the opinion of the investigator or medically qualified designee).
- Currently living in the Indianapolis, Indiana area.
- Currently wearing a removable mandibular partial denture with sufficient room in the posterior buccal flange area to accommodate two enamel specimens.
- Have no current active caries or periodontal disease and all restorations in a good state of repair.
- Have a salivary flow rate in the range of normal values.
Who cannot join
- Pregnant or breast feeding women.
- Known or suspected intolerance or hypersensitivity to the study materials or their stated ingredients.
- Currently taking antibiotics or have taken antibiotics in the two weeks prior to the screening visit.
- Unable to measure product weights accurately using the assigned study scale as determined by the study staff as demonstrated.
- Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
- Have received a professional fluoride treatment within 14 days of randomization to the first treatment.
- Recent history (within the last year) of alcohol or other substance abuse.
About this study
The purpose of this study is to evaluate the effect of the test toothpaste containing 1150 parts per million (ppm) of fluoride (F) on the mineral content of demineralized enamel specimens, in an in situ caries model system, by comparing the differences in net remineralization change (ΔM) following use of the test toothpaste with a fluoride free (0 ppm F) reference control toothpaste.
- Conditions
- Dental Caries
- Being tested
- Toothpaste containing 1150ppm F, Toothpaste containing 0ppm F, Toothpaste containing 250ppm F
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toothpaste containing 1150ppm FDrug
US marketed toothpaste containing 1150ppm of F
Toothpaste containing 0ppm FOther
Experimental toothpaste containing 0ppm F
Toothpaste containing 250ppm FDrug
Experimental toothpaste containing 250ppm F
Toothpaste containing 1150ppm FDrug
Experimental toothpaste containing 1150ppm F
| Study group | Role | What they receive |
|---|---|---|
| Test fluoride toothpaste | Experimental | Participants will apply 1.5 weighed g (± 0.1 g) of the study toothpaste to a wet toothbrush and brush their natural teeth twice daily for one timed minute. Participants will wear their mandibular partial denture with test specimens while brushing and continuously for 24 hours a day during each of the 4-week treatment periods Receives: Drug: Toothpaste containing 1150ppm F |
| Fluoride free (0ppm F) reference control toothpaste | Placebo comparator | Participants will apply 1.5 weighed g (± 0.1 g) of the study toothpaste to a wet toothbrush and brush their natural teeth twice daily for one timed minute. Participants will wear their mandibular partial denture with test specimens while brushing and continuously for 24 hours a day during each of the 4-week treatment periods. Receives: Other: Toothpaste containing 0ppm F |
| Low dose fluoride (250ppm F) reference control toothpaste | Active comparator | Participants will apply 1.5 weighed g (± 0.1 g) of the study toothpaste to a wet toothbrush and brush their natural teeth twice daily for one timed minute. Participants will wear their mandibular partial denture with test specimens while brushing and continuously for 24 hours a day during each of the 4-week treatment periods. Receives: Drug: Toothpaste containing 250ppm F |
| Fluoride (1150ppm F) reference control toothpaste | Active comparator | Participants will apply 1.5 weighed g (± 0.1 g) of the study toothpaste to a wet toothbrush and brush their natural teeth twice daily for one timed minute. Participants will wear their mandibular partial denture with test specimens while brushing and continuously for 24 hours a day during each of the 4-week treatment periods. Receives: Drug: Toothpaste containing 1150ppm F |
What is being measured
The primary outcome is the main question the study is designed to answer.
Net remineralization change (ΔM) of demineralised enamel specimens following use of the test toothpaste with a fluoride free reference control toothpaste
The change in mineral content (ΔM) of the lesions as measured by Transverse Microradiography (TMR) will be calculated by the following formula: ΔM= (Post-treatment ΔZ - baseline ΔZ)
Measured: 4 weeks
Secondary outcomes (3)
Net remineralization change (ΔM) of demineralised enamel specimens following use of the test toothpaste with all other treatments
The change in mineral content (ΔM) of the lesions as measured by TMR will be calculated by the following formula: ΔM= (Post-treatment ΔZ - baseline ΔZ)
Measured: 4 weeks
Changes in enamel lesion depth (ΔL) following use of the test toothpaste with all other treatments
The change in lesion depth (ΔL) as measured by TMR will be calculated by: ΔL= (Post-treatment lesion depth - baseline lesion depth)
Measured: 4 weeks
Net change in surface zone mineral content (ΔSZmax) following use of the toothpaste with all other treatments
The change in SZmax (ΔSZmax) as measured by TMR will be calculated by: ΔSZmax= (Post-treatment SZmax - baseline SZmax)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startDec 2015
- Primary completionNov 2016 (estimated)
- Study completionNov 2016 (estimated)
Why it stopped: This study was cancelled. No subjects were enrolled and no data has been collected
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02436473
- Sponsor's protocol ID
- 203161
- Status last verified
- Aug 2015
- First submitted
- 4 May 2015
- Last updated
- 13 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Fluoride Toothpastes Using an In Situ Caries Model
- ClinicalTrials.gov ID
- NCT02436473
- Acronym / sponsor ID
- 203161
- Conditions
- Dental Caries
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study was cancelled. No subjects were enrolled and no data has been collected
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 6 May 2015 (estimated)
- 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 purpose of this study is to evaluate the effect of the test toothpaste containing 1150 parts per million (ppm) of fluoride (F) on the mineral content of demineralized enamel specimens, in an in situ caries model system, by comparing the differences in net remineralization change (ΔM) following use of the test toothpaste with a fluoride free (0 ppm F) reference control toothpaste.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Test fluoride toothpaste | Experimental | Drug: Toothpaste containing 1150ppm FParticipants will apply 1.5 weighed g (± 0.1 g) of the study toothpaste to a wet toothbrush and brush their natural teeth twice daily for one timed minute. Participants will wear their mandibular partial denture with test specimens while brushing and continuously for 24 hours a day during each of the 4-week treatment periods |
| Fluoride free (0ppm F) reference control toothpaste | Placebo comparator | Other: Toothpaste containing 0ppm FParticipants will apply 1.5 weighed g (± 0.1 g) of the study toothpaste to a wet toothbrush and brush their natural teeth twice daily for one timed minute. Participants will wear their mandibular partial denture with test specimens while brushing and continuously for 24 hours a day during each of the 4-week treatment periods. |
| Low dose fluoride (250ppm F) reference control toothpaste | Active comparator | Drug: Toothpaste containing 250ppm FParticipants will apply 1.5 weighed g (± 0.1 g) of the study toothpaste to a wet toothbrush and brush their natural teeth twice daily for one timed minute. Participants will wear their mandibular partial denture with test specimens while brushing and continuously for 24 hours a day during each of the 4-week treatment periods. |
| Fluoride (1150ppm F) reference control toothpaste | Active comparator | Drug: Toothpaste containing 1150ppm FParticipants will apply 1.5 weighed g (± 0.1 g) of the study toothpaste to a wet toothbrush and brush their natural teeth twice daily for one timed minute. Participants will wear their mandibular partial denture with test specimens while brushing and continuously for 24 hours a day during each of the 4-week treatment periods. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Demonstrates understanding of the study.
- Aged 18 to 85 years.
- Understands and is willing, able and likely to comply with all study procedures and restrictions.
- Has good general health (in the opinion of the investigator or medically qualified designee).
- Currently living in the Indianapolis, Indiana area.
Key exclusion criteria (7 listed)
- Pregnant or breast feeding women.
- Known or suspected intolerance or hypersensitivity to the study materials or their stated ingredients.
- Currently taking antibiotics or have taken antibiotics in the two weeks prior to the screening visit.
- Unable to measure product weights accurately using the assigned study scale as determined by the study staff as demonstrated.
- Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
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 |
|---|---|---|
| Toothpaste containing 1150ppm FUS marketed toothpaste containing 1150ppm of F | Drug | Test fluoride toothpaste |
| Toothpaste containing 0ppm FExperimental toothpaste containing 0ppm F | Other | Fluoride free (0ppm F) reference control toothpaste |
| Toothpaste containing 250ppm FExperimental toothpaste containing 250ppm F | Drug | Low dose fluoride (250ppm F) reference control toothpaste |
| Toothpaste containing 1150ppm FExperimental toothpaste containing 1150ppm F | Drug | Fluoride (1150ppm F) reference control toothpaste |
Primary outcome
Net remineralization change (ΔM) of demineralised enamel specimens following use of the test toothpaste with a fluoride free reference control toothpaste
Time frame: 4 weeks
The change in mineral content (ΔM) of the lesions as measured by Transverse Microradiography (TMR) will be calculated by the following formula: ΔM= (Post-treatment ΔZ - baseline ΔZ)
3 secondary outcomes
Net remineralization change (ΔM) of demineralised enamel specimens following use of the test toothpaste with all other treatments
Time frame: 4 weeks
Changes in enamel lesion depth (ΔL) following use of the test toothpaste with all other treatments
Time frame: 4 weeks
Net change in surface zone mineral content (ΔSZmax) following use of the toothpaste with all other treatments
Time frame: 4 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2015.
Related trials for Dental Caries
Active, not recruiting
Clinical Evaluation of a New Dual-cure Universal Adhesive
Class I Dental Restorations, Class II Dental Restorations
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Not yet recruiting
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars
Dental Caries
Not yet recruiting
Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities
Dental Caries, Cavity, Dental
Not yet recruiting
Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
Dental Caries, Dental Plaque
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.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
A study testing Toothpaste containing 1150ppm F, Toothpaste containing 0ppm F and Toothpaste containing 250ppm F in people with Dental Caries, run by GlaxoSmithKline.
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 7 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: withdrawn, as of the sponsor's last update on 13 Aug 2015. 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 was withdrawn before enrolling participants, so there are no results.
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?
Net remineralization change (ΔM) of demineralised enamel specimens following use of the test toothpaste with a fluoride free reference control toothpaste (time frame: 4 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 13 Aug 2015.