Dental CariesPhase 4NCT01563172
Effect of Dentifrice Usage Regime on Delivery and Efficacy of Fluoride
A Phase 4 study testing Sodium fluoride / silica and carbopol, 0.5g, Sodium fluoride / silica and carbopol, 1.5g and Fluoride free dentifrice in people with Dental Caries, run by GlaxoSmithKline at 1 site in United States.
Trial summary
This study will evaluate and compare the effect of the amount of toothpaste used and brushing time on enamel strengthening (percent of surface microhardness recovery, % SMHR) and enamel fluoride uptake (EFU). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Sodium fluoride / silica and carbopol, 0.5g, Sodium fluoride / silica and carbopol, 1.5g and Fluoride free dentifrice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2009to 1 Jun 2009
- Phase
- Phase 4
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- General and Dental Health
- Good general and dental health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or oral examination
- Have no current active caries or periodontal disease that may compromise the study or the health of the subjects
- Residency: Currently living in the Indianapolis, Indiana area
- 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 mm x 7 mm)
Show all 9Show fewer
- Willing to have their denture modified to accommodate enamel test specimens and willing and capable of wearing their removable mandibular partial dentures 24 hours per day during the experimental periods
- 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/minute; gum base stimulated whole saliva flow rate ≥ 0.8 mL/minute)
Who cannot join
- Antibiotics: Use of antibiotics two weeks prior to a treatment visit or anticipated use during the study treatment periods
- Study Scale Use: Subjects unable to measure product weights accurately using the assigned study scale as determined by the study staff (as demonstrated on or before Visit 4)
- A member of the site study staff who is directly working on the project or living in that staff's household
- Any employee of any toothpaste manufacturer or their spouse or family member
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University School of Dentistry
Indianapolis, Indiana, 46202
About this study
Official title: A Study to Measure the Effect of Dentifrice Usage Regime on Delivery and Efficacy of Fluoride Using an In Situ Caries Model
This study will evaluate and compare the effect of the amount of toothpaste used and brushing time on enamel strengthening (percent of surface microhardness recovery, % SMHR) and enamel fluoride uptake (EFU).
- Conditions
- Dental Caries
- Being tested
- Sodium fluoride / silica and carbopol, 0.5g, Sodium fluoride / silica and carbopol, 1.5g, Fluoride free dentifrice
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium fluoride / silica and carbopol, 0.5gDrug
Dentifrice containing 1150 parts per million (ppm) fluoride as sodium fluoride / silica and 0.4% carbopol
Sodium fluoride / silica and carbopol, 1.5gDrug
Dentifrice containing 1150 ppm fluoride as sodium fluoride / silica and 0.4% carbopol
Sodium fluoride / silica and carbopol, 1.5gDrug
Dentifrice containing 250 ppm fluoride as sodium fluoride / silica and 0.4% carbopol
Fluoride free dentifriceOther
A non fluoride dentifrice was given to participants of each arm at washout period
| Study group | Role | What they receive |
|---|---|---|
| Experimental dentifrice 0.5g, 45 seconds brushing group | Experimental | Participants brush twice a daily for 45 seconds with experimental dentifrice. Receives: Drug: Sodium fluoride / silica and carbopol, 0.5g; Other: Fluoride free dentifrice |
| Experimental dentifrice 1.5g, 45 seconds brushing group | Experimental | Participants brush twice a daily for 45 seconds with experimental dentifrice. Receives: Drug: Sodium fluoride / silica and carbopol, 1.5g; Other: Fluoride free dentifrice |
| Experimental dentifrice 0.5g, 2 minutes brushing group | Experimental | Participants brush twice a daily for 2 minutes with experimental dentifrice. Receives: Drug: Sodium fluoride / silica and carbopol, 0.5g; Other: Fluoride free dentifrice |
| Experimental dentifrice 1.5g, 2 minutes brushing group | Experimental | Participants brush twice a daily for 2 minutes with experimental dentifrice. Receives: Drug: Sodium fluoride / silica and carbopol, 1.5g; Other: Fluoride free dentifrice |
| Contol group | Active comparator | Participants brush twice a daily for 2 minutes with controll dentifrice. Receives: Drug: Sodium fluoride / silica and carbopol, 1.5g; Other: Fluoride free dentifrice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Surface Micro Hardness Recovery (% SMH), of Brushing for 2 Minutes Versus (vs.) Brushing for 45 Seconds With 1.5g of Experimental Dentifrice.
SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and 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. % SMH recovery was calculated from indentation length (micrometer [μm]) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): [D1-R/D1-B] ×100.
Measured: At Baseline and at Day 14
Secondary outcomes (9)
Percentage Surface Micro Hardness (% SMH) Recovery , of Brushing for 2 Minutes vs. Brushing for 45 Seconds With 0.5g of Experimental Dentifrice.
SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and 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. % SMH recovery was calculated from indentation length (μm) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): [D1-R/D1-B] ×100.
Measured: At Baseline and at Day 14
Percentage Surface Micro Hardness (% SMH) Recovery, of Brushing for 2 Minutes With 0.5g of Experimental Dentifrice vs. Brushing for 2 Minutes With 1.5g of Experimental Dentifrice.
SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and 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. % SMH recovery was calculated from indentation length (μm) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): [D1-R/D1-B] ×100.
Measured: At Baseline and at Day 14
Percentage Surface Micro-hardness Recovery (% SMH), of Brushing for 45 Seconds With 0.5g of Experimental Dentifrice vs. Brushing for 45 Seconds With 1.5g of Experimental Dentifrice.
SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and 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. % SMH recovery was calculated from indentation length (μm) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): [D1-R/D1-B] ×100.
Measured: At Baseline and at Day 14
Percent Surface Micro-hardness (% SMH) Recovery, of Brushing for 2 Minutes With 1.5g of Experimental Dentifrice vs. Brushing for 2 Minutes With 1.5g of an Control Dentifrice.
SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and 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. % SMH recovery was calculated from indentation length (μm) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): [D1-R/D1-B] ×100.
Measured: At Baseline and at Day 14
Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes vs. Brushing for 45 Seconds With 1.5g of Experimental Dentifrice.
EFU was measured by using micro-drill analysis of the enamel specimens carried out after 14 days of intra-oral exposure for each of the toothpaste treatments. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores.
Measured: At Day 14
Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes vs. Brushing for 45 Seconds With 0.5g of Experimental Dentifrice.
EFU was measured by using micro-drill analysis of the enamel specimens carried out after 14 days of intra-oral exposure for each of the toothpaste treatments. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores.
Measured: At Day 14
Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes With 0.5g of Experimental Dentifrice vs. Brushing for 2 Minutes With 1.5g of Experimental Dentifrice.
EFU was measured by using micro-drill analysis of the enamel specimens carried out after 14 days of intra-oral exposure for each of the toothpaste treatments. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores.
Measured: At Day 14
Enamel Fluoride Uptake (EFU) After Brushing for 45 Seconds With 0.5g of Experimental Dentifrice vs. Brushing for 45 Seconds With 1.5g of Experimental Dentifrice.
EFU was measured by using micro-drill analysis of the enamel specimens carried out after 14 days of intra-oral exposure for each of the toothpaste treatments. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores.
Measured: At Day 14
Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes With 1.5g of Experimental Dentifrice vs. Brushing for 2 Minutes With 1.5g of Control Dentifrice.
EFU was measured by using micro-drill analysis of the enamel specimens carried out after 14 days of intra-oral exposure for each of the toothpaste treatments. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores.
Measured: At Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2012 (estimated)
- Study start1 Jan 2009
- Primary completion1 Jun 2009
- Study completion1 Jun 2009
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.
- Publications (2)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 65 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
- NCT01563172
- Sponsor's protocol ID
- T3158587
- Status last verified
- Jan 2018
- First submitted
- 16 Feb 2012
- Last updated
- 7 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
https://clinicaltrials.gov/ct2/show/results/NCT01563172?term=T3158587&rank=1
Creeth JE, Kelly SA, Gonzalez-Cabezas C, Karwal R, Martinez-Mier EA, Lynch RJM, Bosma ML, Zero DT. Effect of toothbrushing duration and dentifrice quantity on enamel remineralisation: An in situ randomized clinical trial. J Dent. 2016 Dec;55:61-67. doi: 10.1016/j.jdent.2016.10.003. Epub 2016 Oct 4.
PubMed 27717756
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Measure the Effect of Dentifrice Usage Regime on Delivery and Efficacy of Fluoride Using an In Situ Caries Model
- ClinicalTrials.gov ID
- NCT01563172
- Acronym / sponsor ID
- T3158587
- Conditions
- Dental Caries
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 1 Jun 2009 (actual)
- Study completion
- 1 Jun 2009 (actual)
- First posted
- 26 Mar 2012 (estimated)
- Results
- Posted 10 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate and compare the effect of the amount of toothpaste used and brushing time on enamel strengthening (percent of surface microhardness recovery, % SMHR) and enamel fluoride uptake (EFU).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Experimental dentifrice 0.5g, 45 seconds brushing group | Experimental | Drug: Sodium fluoride / silica and carbopol, 0.5g, Other: Fluoride free dentifriceParticipants brush twice a daily for 45 seconds with experimental dentifrice. |
| Experimental dentifrice 1.5g, 45 seconds brushing group | Experimental | Drug: Sodium fluoride / silica and carbopol, 1.5g, Other: Fluoride free dentifriceParticipants brush twice a daily for 45 seconds with experimental dentifrice. |
| Experimental dentifrice 0.5g, 2 minutes brushing group | Experimental | Drug: Sodium fluoride / silica and carbopol, 0.5g, Other: Fluoride free dentifriceParticipants brush twice a daily for 2 minutes with experimental dentifrice. |
| Experimental dentifrice 1.5g, 2 minutes brushing group | Experimental | Drug: Sodium fluoride / silica and carbopol, 1.5g, Other: Fluoride free dentifriceParticipants brush twice a daily for 2 minutes with experimental dentifrice. |
| Contol group | Active comparator | Drug: Sodium fluoride / silica and carbopol, 1.5g, Other: Fluoride free dentifriceParticipants brush twice a daily for 2 minutes with controll dentifrice. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- General and Dental Health
- Good general and dental health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or oral examination
- Have no current active caries or periodontal disease that may compromise the study or the health of the subjects
- Residency: 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 (required dimensions 12 mm x 7 mm)
Key exclusion criteria (4 listed)
- Antibiotics: Use of antibiotics two weeks prior to a treatment visit or anticipated use during the study treatment periods
- Study Scale Use: Subjects unable to measure product weights accurately using the assigned study scale as determined by the study staff (as demonstrated on or before Visit 4)
- A member of the site study staff who is directly working on the project or living in that staff's household
- Any employee of any toothpaste manufacturer or their spouse or family member
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 |
|---|---|---|
| Sodium fluoride / silica and carbopol, 0.5gDentifrice containing 1150 parts per million (ppm) fluoride as sodium fluoride / silica and 0.4% carbopol | Drug | Experimental dentifrice 0.5g, 2 minutes brushing group, Experimental dentifrice 0.5g, 45 seconds brushing group |
| Sodium fluoride / silica and carbopol, 1.5gDentifrice containing 1150 ppm fluoride as sodium fluoride / silica and 0.4% carbopol | Drug | Experimental dentifrice 1.5g, 2 minutes brushing group, Experimental dentifrice 1.5g, 45 seconds brushing group |
| Sodium fluoride / silica and carbopol, 1.5gDentifrice containing 250 ppm fluoride as sodium fluoride / silica and 0.4% carbopol | Drug | Contol group |
| Fluoride free dentifriceA non fluoride dentifrice was given to participants of each arm at washout period | Other | Contol group, Experimental dentifrice 0.5g, 2 minutes brushing group, Experimental dentifrice 0.5g, 45 seconds brushing group, Experimental dentifrice 1.5g, 2 minutes brushing group, Experimental dentifrice 1.5g, 45 seconds brushing group |
Primary outcome
Percentage Surface Micro Hardness Recovery (% SMH), of Brushing for 2 Minutes Versus (vs.) Brushing for 45 Seconds With 1.5g of Experimental Dentifrice.
Time frame: At Baseline and at Day 14
SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and 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. % SMH recovery was calculated from indentation length (micrometer [μm]) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): [D1-R/D1-B] ×100.
9 secondary outcomes
Percentage Surface Micro Hardness (% SMH) Recovery , of Brushing for 2 Minutes vs. Brushing for 45 Seconds With 0.5g of Experimental Dentifrice.
Time frame: At Baseline and at Day 14
Percentage Surface Micro Hardness (% SMH) Recovery, of Brushing for 2 Minutes With 0.5g of Experimental Dentifrice vs. Brushing for 2 Minutes With 1.5g of Experimental Dentifrice.
Time frame: At Baseline and at Day 14
Percentage Surface Micro-hardness Recovery (% SMH), of Brushing for 45 Seconds With 0.5g of Experimental Dentifrice vs. Brushing for 45 Seconds With 1.5g of Experimental Dentifrice.
Time frame: At Baseline and at Day 14
Percent Surface Micro-hardness (% SMH) Recovery, of Brushing for 2 Minutes With 1.5g of Experimental Dentifrice vs. Brushing for 2 Minutes With 1.5g of an Control Dentifrice.
Time frame: At Baseline and at Day 14
Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes vs. Brushing for 45 Seconds With 1.5g of Experimental Dentifrice.
Time frame: At Day 14
Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes vs. Brushing for 45 Seconds With 0.5g of Experimental Dentifrice.
Time frame: At Day 14
Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes With 0.5g of Experimental Dentifrice vs. Brushing for 2 Minutes With 1.5g of Experimental Dentifrice.
Time frame: At Day 14
Enamel Fluoride Uptake (EFU) After Brushing for 45 Seconds With 0.5g of Experimental Dentifrice vs. Brushing for 45 Seconds With 1.5g of Experimental Dentifrice.
Time frame: At Day 14
Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes With 1.5g of Experimental Dentifrice vs. Brushing for 2 Minutes With 1.5g of Control Dentifrice.
Time frame: At Day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationhttps://clinicaltrials.gov/ct2/show/results/NCT01563172?term=T3158587&rank=1
- Derived from this study: PubMed 27717756Creeth JE, Kelly SA, Gonzalez-Cabezas C, Karwal R, Martinez-Mier EA, Lynch RJM, Bosma ML, Zero DT. Effect of toothbrushing duration and dentifrice quantity on enamel remineralisation: An in situ randomized clinical trial. J Dent. 2016 Dec;55:61-67. doi: 10.1016/j.jdent.2016.10.003. Epub 2016 Oct 4.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sodium fluoride / silica and carbopol, 0.5g, Sodium fluoride / silica and carbopol, 1.5g and Fluoride free dentifrice in people with Dental Caries, run by GlaxoSmithKline at 1 site in United States.
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 9 inclusion and 4 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 7 Feb 2018. 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 States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 10 Aug 2017). 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 (% SMH), of Brushing for 2 Minutes Versus (vs.) Brushing for 45 Seconds With 1.5g of Experimental Dentifrice. (time frame: At Baseline and at Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01563172, which also lists 2 linked publications.
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 7 Feb 2018.