Dental ErosionPhase 2NCT00752089
Experimental Dentifrice Remineralization/Fluoride Uptake in an in Situ Model
A Phase 2 study testing NaF/ KNO3/isopentane Dentifrice, NaF/KNO3 Dentifrice and NaF Dentifrice in people with Dental Erosion, run by GlaxoSmithKline.
Trial summary
The purpose of this study is to determine whether an experimental fluoridated dentifrice is effective in the treatment of dental caries Read more about this study
- Who is it for?
- Ages 18 to 78 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Erosion
- What is being tested?
- NaF/ KNO3/isopentane Dentifrice, NaF/KNO3 Dentifrice and NaF Dentifrice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Sep 2007to Jan 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 78 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: Aged between 18 and 78
- Fluoride: Currently living in the Indianapolis area which has a fluoridated water supply (1 ppm F) and not taking fluoride supplements for medical reasons
- Dentures: Currently wearing a removable mandibular partial denture with sufficient room in the posterior buccal flange area to accommodate two enamel specimens (required dimensions 12 x 7 mm). Willing and capable of wearing their removable partial dentures 24 hours per day during the experimental periods
- Dental health:Have no current active caries or periodontal disease that may compromise the study or the health of the participants and all restorations in a good state of repair
- Salivary flow:Have a salivary flow rate in the range of normal values (unstimulated whole saliva flow rate ≥ 0.2 mL/min; gum base stimulated whole saliva flow rate ≥ 0.8 mL/min
- Compliance: Understands and is willing, able and likely to comply with all study procedures and restrictions
- Consent:Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form
- General Health: Good general health with (in the opinion of the investigator) no clinically significant and/or relevant abnormalities of medical history or oral examination that could interfere with participant safety during the study period
Who cannot join
- Antibiotics:Currently taking antibiotics or have taken antibiotics in the two weeks prior to the screening visit
- Allergy/Intolerance:Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
- Pregnancy:Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
- Breast-feeding:Women who are breast-feeding.
- Clinical Study/Experimental Medication: Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit
- Personnel:An employee of the sponsor or the study site who is directly involved in the study
About this study
Official title: Exploratory Evaluation of an Experimental Fluoride Dentifrice Formulation Using an in Situ Remineralization/Fluoride Uptake Model
The purpose of this study is to determine whether an experimental fluoridated dentifrice is effective in the treatment of dental caries
Read the detailed description
Topical fluorides have been proven to be clinically effective in the prevention of dental caries. It is generally agreed that anti-caries effect of fluoride (F) is mainly by decreasing the rate of enamel demineralization and enhancing the rate of enamel remineralization. An in-situ Surface Micro-hardness (SMH) test is widely used to evaluate enamel demineralization and remineralization during the caries process. Determination of fluoride uptake in-situ also provides better estimation of true fluoride bioavailability of fluoride dentifrice products. In this study, an in-situ remineralization fluoride uptake model will be used to compare the efficacy of experimental dentifrice with a marketed dentifrice and placebo dentifrice. Participants wore partial dentures containing two partially demineralized enamel specimens for two weeks- 24 hours per day, except when brushing (twice daily) with test dentifrice. Following each treatment period, the enamel specimens were analyzed for SMH recovery and fluoride uptake through microdrill enamel biopsy technique.
- Conditions
- Dental Erosion
- Being tested
- NaF/ KNO3/isopentane Dentifrice, NaF/KNO3 Dentifrice, NaF Dentifrice, Placebo Dentifrice
- Keywords
- enamel fluoride uptake, erosion, enamel remineralization
- Medical subject headings
- Tooth Erosion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaF/ KNO3/isopentane DentifriceDrug
Experimental toothpaste
NaF/KNO3 DentifriceDrug
Experimental toothpaste
NaF DentifriceDrug
Active comparator
Placebo DentifriceOther
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| Sodium fluoride/potassium nitrate/Isopentane dentifrice | Experimental | Participants to brush their teeth for one timed minute twice daily with a gel to foam dentifrice containing active ingredients: 1450 ppm F as sodium fluoride (NaF) and 5% potassium nitrate (KNO3) and isopentane as an excipient ingredient. Receives: Drug: NaF/ KNO3/isopentane Dentifrice |
| NaF/KNO3 Dentifrice | Experimental | Participants to brush their teeth for one timed minute twice daily with a gel to foam dentifrice, containing as active ingredients: 1450 ppm NaF and 5% KNO3 but no isopentane. Receives: Drug: NaF/KNO3 Dentifrice |
| NaF Dentifrice | Active comparator | Participants to brush their teeth for one timed minute twice daily with a dentifrice containing 1450 ppm F as NaF. Receives: Drug: NaF Dentifrice |
| Placebo Dentifrice | Placebo comparator | Participants to brush their teeth for one timed minute twice daily with a fluoride free dentifrice (0 ppm F). Receives: Other: Placebo Dentifrice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Surface Micro-hardness Recovery (SMHR) of Enamel Specimens
SMH test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after intra-oral exposure (R) and after in-vitro demineralization (D) using formula: [(D-R)/ (D-B)]*100.
Measured: Baseline to 14 days
Secondary outcomes (1)
Adjusted Mean Change From Baseline in Enamel Fluoride Uptake
Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on the amount of fluoride (F) divided by the area of the enamel cores and expressed as ug*F/cm^3. The difference between treatments was calculated with respect to fluoride uptake by enamel.
Measured: Baseline to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2008 (estimated)
- Study startSep 2007
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dental ErosionStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 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
- NCT00752089
- Sponsor's protocol ID
- Z3120510
- Status last verified
- May 2016
- First submitted
- 11 Sep 2008
- Last updated
- 8 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Evaluation of an Experimental Fluoride Dentifrice Formulation Using an in Situ Remineralization/Fluoride Uptake Model
- ClinicalTrials.gov ID
- NCT00752089
- Acronym / sponsor ID
- Z3120510
- Conditions
- Dental Erosion
- Keywords
- enamel fluoride uptake, erosion, enamel remineralization
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 15 Sep 2008 (estimated)
- Results
- Posted 8 Dec 2016
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 determine whether an experimental fluoridated dentifrice is effective in the treatment of dental caries
Detailed description
Topical fluorides have been proven to be clinically effective in the prevention of dental caries. It is generally agreed that anti-caries effect of fluoride (F) is mainly by decreasing the rate of enamel demineralization and enhancing the rate of enamel remineralization. An in-situ Surface Micro-hardness (SMH) test is widely used to evaluate enamel demineralization and remineralization during the caries process. Determination of fluoride uptake in-situ also provides better estimation of true fluoride bioavailability of fluoride dentifrice products. In this study, an in-situ remineralization fluoride uptake model will be used to compare the efficacy of experimental dentifrice with a marketed dentifrice and placebo dentifrice. Participants wore partial dentures containing two partially demineralized enamel specimens for two weeks- 24 hours per day, except when brushing (twice daily) with test dentifrice. Following each treatment period, the enamel specimens were analyzed for SMH recovery and fluoride uptake through microdrill enamel biopsy technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sodium fluoride/potassium nitrate/Isopentane dentifrice | Experimental | Drug: NaF/ KNO3/isopentane DentifriceParticipants to brush their teeth for one timed minute twice daily with a gel to foam dentifrice containing active ingredients: 1450 ppm F as sodium fluoride (NaF) and 5% potassium nitrate (KNO3) and isopentane as an excipient ingredient. |
| NaF/KNO3 Dentifrice | Experimental | Drug: NaF/KNO3 DentifriceParticipants to brush their teeth for one timed minute twice daily with a gel to foam dentifrice, containing as active ingredients: 1450 ppm NaF and 5% KNO3 but no isopentane. |
| NaF Dentifrice | Active comparator | Drug: NaF DentifriceParticipants to brush their teeth for one timed minute twice daily with a dentifrice containing 1450 ppm F as NaF. |
| Placebo Dentifrice | Placebo comparator | Other: Placebo DentifriceParticipants to brush their teeth for one timed minute twice daily with a fluoride free dentifrice (0 ppm F). |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age: Aged between 18 and 78
- Fluoride: Currently living in the Indianapolis area which has a fluoridated water supply (1 ppm F) and not taking fluoride supplements for medical reasons
- Dentures: Currently wearing a removable mandibular partial denture with sufficient room in the posterior buccal flange area to accommodate two enamel specimens (required dimensions 12 x 7 mm). Willing and capable of wearing their removable partial dentures 24 hours per day during the experimental periods
- Dental health:Have no current active caries or periodontal disease that may compromise the study or the health of the participants and all restorations in a good state of repair
- Salivary flow:Have a salivary flow rate in the range of normal values (unstimulated whole saliva flow rate ≥ 0.2 mL/min; gum base stimulated whole saliva flow rate ≥ 0.8 mL/min
Key exclusion criteria (6 listed)
- Antibiotics:Currently taking antibiotics or have taken antibiotics in the two weeks prior to the screening visit
- Allergy/Intolerance:Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
- Pregnancy:Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
- Breast-feeding:Women who are breast-feeding.
- Clinical Study/Experimental Medication: 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 |
|---|---|---|
| NaF/ KNO3/isopentane DentifriceExperimental toothpaste | Drug | Sodium fluoride/potassium nitrate/Isopentane dentifrice |
| NaF/KNO3 DentifriceExperimental toothpaste | Drug | NaF/KNO3 Dentifrice |
| NaF DentifriceActive comparator | Drug | NaF Dentifrice |
| Placebo DentifricePlacebo comparator | Other | Placebo Dentifrice |
Primary outcome
Percentage Surface Micro-hardness Recovery (SMHR) of Enamel Specimens
Time frame: Baseline to 14 days
SMH test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after intra-oral exposure (R) and after in-vitro demineralization (D) using formula: [(D-R)/ (D-B)]*100.
1 secondary outcome
Adjusted Mean Change From Baseline in Enamel Fluoride Uptake
Time frame: Baseline to 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NaF/ KNO3/isopentane Dentifrice, NaF/KNO3 Dentifrice and NaF Dentifrice in people with Dental Erosion, 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 6 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 8 Dec 2016. 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.
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?
Yes. Results are posted in the registry (first posted 8 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage Surface Micro-hardness Recovery (SMHR) of Enamel Specimens (time frame: Baseline to 14 days). 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 8 Dec 2016.