Dental CariesNCT02751320
Efficacy of Three Toothpastes Using an in Situ Caries Model
A study testing 0.425 % w/w phytate,1150ppm F, 0.85 % w/w phytate,1150ppm F and 0.85 % w/w phytate,0.3%ZnCl2 0.5% sodium citrate, 1150ppm F in people with Dental Caries, run by GlaxoSmithKline at 1 site in United States.
Trial summary
This will be a single-centre, randomized, blinded, placebo-controlled, 6-treatment, 4-period crossover, incomplete block design, in situ caries study in healthy adults who wear a removable bilateral mandibular partial denture. 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?
- 0.425 % w/w phytate,1150ppm F, 0.85 % w/w phytate,1150ppm F and 0.85 % w/w phytate,0.3%ZnCl2 0.5% sodium citrate, 1150ppm F
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2016to 11 Aug 2016
- Phase
- Interventional
- 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 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).
- A salivary flow-rate in the range of normal values (unstimulated whole saliva flow- Rate ≥ 0.2 g/minute (min); gum base stimulated whole saliva flow-Rate ≥ 0.8 g/min).
- 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.
- Willing and capable of brushing their natural teeth with the lower partial denture in place.
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.
Trial locations and contacts
1 site in 1 country.
United States1 site
GSK Investigational Site
Indianapolis, Indiana, 46202
About this study
Official title: Clinical Efficacy of Three Experimental Toothpastes Using an in Situ Caries Model
This will be a single-centre, randomized, blinded, placebo-controlled, 6-treatment, 4-period crossover, incomplete block design, in situ caries study in healthy adults who wear a removable bilateral mandibular partial denture. The denture will be modified to accommodate 4 gauze-covered specimens of human dental enamel (4x3mm) that have been previously demineralized in vitro to form either S or low-R lesions (2 specimens of each lesion type will be used with each participant). After 14 days of twice daily product use off-site, the 2 S lesion specimens will be removed at the study site, with the remaining 2 low-R lesion specimens removed at the study site after a further 14 days of product use. To determine the remineralization ability of the treatments, all specimens will be analyzed by transverse microradiography (TMR) and enamel fluoride uptake (EFU), with the S lesions additionally analyzed by surface micro hardness (SMH) and the low-R lesions additionally analyzed by quantitative light fluorescence (QLF).
- Conditions
- Dental Caries
- Being tested
- 0.425 % w/w phytate,1150ppm F, 0.85 % w/w phytate,1150ppm F, 0.85 % w/w phytate,0.3%ZnCl2 0.5% sodium citrate, 1150ppm F, 0 ppm F, 1150ppm 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.
0.425 % w/w phytate,1150ppm FDrug
Participants were assigned with 1.5±0.1g twice daily dentifrice for one timed minute.
0.85 % w/w phytate,1150ppm FDrug
Participants were assigned with 1.5±0.1g twice daily dentifrice for one timed minute.
0.85 % w/w phytate,0.3%ZnCl2 0.5% sodium citrate, 1150ppm FDrug
Participants were assigned with 1.5±0.1g twice daily dentifrice for one timed minute.
0 ppm FOther
Participants were assigned with 1.5±0.1g twice daily dentifrice for one timed minute.
1150ppm FDrug
Participants were assigned with 1.5±0.1g twice daily dentifrice for one timed minute.
0.3%ZnCl2, 0.5% sodium citrate, 1150ppm FDrug
Participants were assigned with 1.5±0.1g twice daily dentifrice for one timed minute.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Dentifrice1 | Experimental | Participants will brush their natural teeth with a pre-wetted toothbrush and their assigned dentifrice for one timed minute, ensuring the enamel specimens retained within their mouths are not directly brushed. Participants should then rinse their mouths with 15ml of tap water for approximately 10s. Receives: Drug: 0.425 % w/w phytate,1150ppm F |
| Experimental Dentifrice 2 | Experimental | Participants will brush their natural teeth with a pre-wetted toothbrush and their assigned dentifrice for one timed minute, ensuring the enamel specimens retained within their mouths are not directly brushed. Participants should then rinse their mouths with 15ml of tap water for approximately 10s. Receives: Drug: 0.85 % w/w phytate,1150ppm F |
| Experimental Dentifrice 3 | Experimental | Participants will brush their natural teeth with a pre-wetted toothbrush and their assigned dentifrice for one timed minute, ensuring the enamel specimens retained within their mouths are not directly brushed. Participants should then rinse their mouths with 15ml of tap water for approximately 10s. Receives: Drug: 0.85 % w/w phytate,0.3%ZnCl2 0.5% sodium citrate, 1150ppm F |
| Reference Product 1 | Placebo comparator | Participants will brush their natural teeth with a pre-wetted toothbrush and their assigned dentifrice for one timed minute, ensuring the enamel specimens retained within their mouths are not directly brushed. Participants should then rinse their mouths with 15ml of tap water for approximately 10s. Receives: Other: 0 ppm F |
| Reference Product 2 | Active comparator | Participants will brush their natural teeth with a pre-wetted toothbrush and their assigned dentifrice for one timed minute, ensuring the enamel specimens retained within their mouths are not directly brushed. Participants should then rinse their mouths with 15ml of tap water for approximately 10s. Receives: Drug: 1150ppm F |
| Reference Product 3 | Active comparator | Participants will brush their natural teeth with a pre-wetted toothbrush and their assigned dentifrice for one timed minute, ensuring the enamel specimens retained within their mouths are not directly brushed. Participants should then rinse their mouths with 15ml of tap water for approximately 10s. Receives: Drug: 0.3%ZnCl2, 0.5% sodium citrate, 1150ppm F |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Surface Microhardness Recovery (SMHR) of Phyte (0% 0.425% and 0.85%) at 2 Weeks
SMHR test was used to assess the changes in mineralization status of partially demineralized enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. % SMHR was calculated from indentation length (micrometer [μm]) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization(D), indentation length (μm) after intra-oral exposure (R): [D-R/D-B]*100.
Measured: Baseline upto 2 weeks
Secondary outcomes (5)
% SMHR of 0.85% Phytate Compared to 0% Phytate, in Presence of 1150ppm Fluoride and 0.3% ZnCl2, 0.3% ZnCl2 Compared to 0% ZnCl2 in the Presence of 1150ppm Fluoride and 0.3% ZnCl2 Compared to 0% ZnCl2 in the Presence of 1150ppm Fluoride and 0.85% Phytate
SMHR test was used to assess the changes in mineralization status of partially demineralized enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. % SMHR was calculated from indentation length (μm) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization(D), indentation length (μm) after intra-oral exposure (R): [D-R/D-B]*100.
Measured: Baseline upto 2 weeks
Transverse Microradiography (TMR) Net Remineralization Change (ΔM) Value of Phytate (0% 0.452% and 0.85%) at 4 Weeks
TMR was used to assess changes in the mineral status of partially demineralized enamel specimens. Lesions were analyzed at baseline and Integrated Mineral Loss (∆Z): (∆Z =(lesion depth x 87) - area under the curve [Area under the curve which relates volume % mineral at distances from the specimen surface with respect to section thickness]). After treatment a further section was taken from each lesion specimen for radiography assessment; ∆Z was calculated. The change which occurred in mineral content (∆M) of the lesions as a result of treatment was calculated by: ∆M= (baseline ∆Z - Post-treatment ∆Z).
Measured: Baseline upto 4 weeks
TMR Δm Value of 0.85% Phytate Compared to 0% Phytate, in the Presence of 1150ppm F and 0.3% ZnCl2, 0.3% ZnCl2 Compared to 0% ZnCl2 in the Presence of 1150ppm F and 0.3% ZnCl2 Compared to 0% ZnCl2 in the Presence of 1150ppm F and 0.85% Phytate
TMR was used to assess changes in the mineral status of partially demineralized enamel specimens. Lesions were analyzed at baseline and Integrated Mineral Loss (∆Z): (∆Z =(lesion depth x 87) - area under the curve [Area under the curve which relates volume % mineral at distances from the specimen surface with respect to section thickness]). After treatment a further section was taken from each lesion specimen for radiography assessment; ∆Z was calculated. The change which occurred in mineral content (∆M) of the lesions as a result of treatment was calculated by: ∆M= (baseline ∆Z - Post-treatment ∆Z).
Measured: Baseline upto 4 weeks
Enamel Fluoride Uptake (EFU) of All Study Formulation Variables
The microdrill enamel biopsy technique was used to analyze the fluoride uptake by enamel. Each enamel specimen was mounted on the long axis of a drill attached to a microdrill and drilled to a depth of approximately 100 μm through the entire lesion (four cores per specimen). The enamel powder pooled from four drilling samples was then immediately analyzed for fluoride content using fluoride specific electrode and pH/ion meter. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as μg/cm^2.
Measured: At Week 2
Enamel Fluoride Uptake (EFU) of All Study Formulation Variables
The microdrill enamel biopsy technique was used to analyze the fluoride uptake by enamel. Each enamel specimen was mounted on the long axis of a drill attached to a microdrill and drilled to a depth of approximately 100 μm through the entire lesion (four cores per specimen). The enamel powder pooled from four drilling samples was then immediately analyzed for fluoride content using fluoride specific electrode and pH/ion meter. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as μg/cm^2.
Measured: At Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study start1 Feb 2016
- Primary completion1 Jul 2016
- Study completion11 Aug 2016
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 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 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
- NCT02751320
- Sponsor's protocol ID
- 202301
- Status last verified
- Jul 2017
- First submitted
- 21 Apr 2016
- Last updated
- 13 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Three Experimental Toothpastes Using an in Situ Caries Model
- ClinicalTrials.gov ID
- NCT02751320
- Acronym / sponsor ID
- 202301
- Conditions
- Dental Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 1 Jul 2016 (actual)
- Study completion
- 11 Aug 2016 (actual)
- First posted
- 26 Apr 2016 (estimated)
- Results
- Posted 13 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a single-centre, randomized, blinded, placebo-controlled, 6-treatment, 4-period crossover, incomplete block design, in situ caries study in healthy adults who wear a removable bilateral mandibular partial denture. The denture will be modified to accommodate 4 gauze-covered specimens of human dental enamel (4x3mm) that have been previously demineralized in vitro to form either S or low-R lesions (2 specimens of each lesion type will be used with each participant). After 14 days of twice daily product use off-site, the 2 S lesion specimens will be removed at the study site, with the remaining 2 low-R lesion specimens removed at the study site after a further 14 days of product use. To determine the remineralization ability of the treatments, all specimens will be analyzed by transverse microradiography (TMR) and enamel fluoride uptake (EFU), with the S lesions additionally analyzed by surface micro hardness (SMH) and the low-R lesions additionally analyzed by quantitative light fluorescence (QLF).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Experimental Dentifrice1 | Experimental | Drug: 0.425 % w/w phytate,1150ppm FParticipants will brush their natural teeth with a pre-wetted toothbrush and their assigned dentifrice for one timed minute, ensuring the enamel specimens retained within their mouths are not directly brushed. Participants should then rinse their mouths with 15ml of tap water for approximately 10s. |
| Experimental Dentifrice 2 | Experimental | Drug: 0.85 % w/w phytate,1150ppm FParticipants will brush their natural teeth with a pre-wetted toothbrush and their assigned dentifrice for one timed minute, ensuring the enamel specimens retained within their mouths are not directly brushed. Participants should then rinse their mouths with 15ml of tap water for approximately 10s. |
| Experimental Dentifrice 3 | Experimental | Drug: 0.85 % w/w phytate,0.3%ZnCl2 0.5% sodium citrate, 1150ppm FParticipants will brush their natural teeth with a pre-wetted toothbrush and their assigned dentifrice for one timed minute, ensuring the enamel specimens retained within their mouths are not directly brushed. Participants should then rinse their mouths with 15ml of tap water for approximately 10s. |
| Reference Product 1 | Placebo comparator | Other: 0 ppm FParticipants will brush their natural teeth with a pre-wetted toothbrush and their assigned dentifrice for one timed minute, ensuring the enamel specimens retained within their mouths are not directly brushed. Participants should then rinse their mouths with 15ml of tap water for approximately 10s. |
| Reference Product 2 | Active comparator | Drug: 1150ppm FParticipants will brush their natural teeth with a pre-wetted toothbrush and their assigned dentifrice for one timed minute, ensuring the enamel specimens retained within their mouths are not directly brushed. Participants should then rinse their mouths with 15ml of tap water for approximately 10s. |
| Reference Product 3 | Active comparator | Drug: 0.3%ZnCl2, 0.5% sodium citrate, 1150ppm FParticipants will brush their natural teeth with a pre-wetted toothbrush and their assigned dentifrice for one timed minute, ensuring the enamel specimens retained within their mouths are not directly brushed. Participants should then rinse their mouths with 15ml of tap water for approximately 10s. |
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).
- A salivary flow-rate in the range of normal values (unstimulated whole saliva flow- Rate ≥ 0.2 g/minute (min); gum base stimulated whole saliva flow-Rate ≥ 0.8 g/min).
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 |
|---|---|---|
| 0.425 % w/w phytate,1150ppm FParticipants were assigned with 1.5±0.1g twice daily dentifrice for one timed minute. | Drug | Experimental Dentifrice1 |
| 0.85 % w/w phytate,1150ppm FParticipants were assigned with 1.5±0.1g twice daily dentifrice for one timed minute. | Drug | Experimental Dentifrice 2 |
| 0.85 % w/w phytate,0.3%ZnCl2 0.5% sodium citrate, 1150ppm FParticipants were assigned with 1.5±0.1g twice daily dentifrice for one timed minute. | Drug | Experimental Dentifrice 3 |
| 0 ppm FParticipants were assigned with 1.5±0.1g twice daily dentifrice for one timed minute. | Other | Reference Product 1 |
| 1150ppm FParticipants were assigned with 1.5±0.1g twice daily dentifrice for one timed minute. | Drug | Reference Product 2 |
| 0.3%ZnCl2, 0.5% sodium citrate, 1150ppm FParticipants were assigned with 1.5±0.1g twice daily dentifrice for one timed minute. | Drug | Reference Product 3 |
Primary outcome
Percentage Surface Microhardness Recovery (SMHR) of Phyte (0% 0.425% and 0.85%) at 2 Weeks
Time frame: Baseline upto 2 weeks
SMHR test was used to assess the changes in mineralization status of partially demineralized enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. % SMHR was calculated from indentation length (micrometer [μm]) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization(D), indentation length (μm) after intra-oral exposure (R): [D-R/D-B]*100.
5 secondary outcomes
% SMHR of 0.85% Phytate Compared to 0% Phytate, in Presence of 1150ppm Fluoride and 0.3% ZnCl2, 0.3% ZnCl2 Compared to 0% ZnCl2 in the Presence of 1150ppm Fluoride and 0.3% ZnCl2 Compared to 0% ZnCl2 in the Presence of 1150ppm Fluoride and 0.85% Phytate
Time frame: Baseline upto 2 weeks
Transverse Microradiography (TMR) Net Remineralization Change (ΔM) Value of Phytate (0% 0.452% and 0.85%) at 4 Weeks
Time frame: Baseline upto 4 weeks
TMR Δm Value of 0.85% Phytate Compared to 0% Phytate, in the Presence of 1150ppm F and 0.3% ZnCl2, 0.3% ZnCl2 Compared to 0% ZnCl2 in the Presence of 1150ppm F and 0.3% ZnCl2 Compared to 0% ZnCl2 in the Presence of 1150ppm F and 0.85% Phytate
Time frame: Baseline upto 4 weeks
Enamel Fluoride Uptake (EFU) of All Study Formulation Variables
Time frame: At Week 2
Enamel Fluoride Uptake (EFU) of All Study Formulation Variables
Time frame: At Week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2017.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.425 % w/w phytate,1150ppm F, 0.85 % w/w phytate,1150ppm F and 0.85 % w/w phytate,0.3%ZnCl2 0.5% sodium citrate, 1150ppm F 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 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: finished, as of the sponsor's last update on 13 Oct 2017. 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. 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?
Yes. Results are posted in the registry (first posted 13 Oct 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 Microhardness Recovery (SMHR) of Phyte (0% 0.425% and 0.85%) at 2 Weeks (time frame: Baseline upto 2 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 Oct 2017.