Oral HygieneNCT02195583

The Effect of Experimental Dentifrices on Remineralization of Caries Lesions In-situ

A study testing Sodium fluoride (1426 ppm), Sodium fluoride (1150 ppm) and Sodium fluoride (250 ppm) in people with Oral Hygiene, run by GlaxoSmithKline at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will evaluate the effect of experimental sodium fluoride-silica dentifrice formulations, with and without zinc, on remineralization of enamel in situ. Following the remineralization phase, the acid resistance of the new mineral formed will be assessed. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Oral Hygiene
What is being tested?: Sodium fluoride (1426 ppm), Sodium fluoride (1150 ppm) and Sodium fluoride (250 ppm)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 62 participants
Where: 1 siteUnited States
Study dates: Jun 2014to Aug 2014
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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Good general health with no clinically significant and relevant abnormalities of medical history or oral examination
Participants with maxillary dental arch suitable for the retention of the palatal appliance

Who cannot join

Participants taking fluoride supplement
Pregnant or breast-feeding women

Trial locations and contacts

1 site in 1 country.

United States1 site

GSK Investigational Site
Indianapolis, Indiana, 46202

Other trials in United States

About this study

Conditions: Oral Hygiene
Being tested: Sodium fluoride (1426 ppm), Sodium fluoride (1150 ppm), Sodium fluoride (250 ppm), Sodium fluoride (1426 ppm) + zinc base A, Sodium fluoride (1426 ppm) + zinc base B

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sodium fluoride (1426 ppm)Drug
Non-zinc, 1426ppm fluoride as sodium fluoride in a silica gel base
Sodium fluoride (1150 ppm)Drug
Non-zinc, 1150ppm fluoride as sodium fluoride in a silica gel base
Sodium fluoride (250 ppm)Drug
Non-zinc, 250ppm fluoride as sodium fluoride in a silica gel base
Sodium fluoride (1426 ppm) + zinc base ADrug
Zinc base A, 1426ppm fluoride as sodium fluoride in a silica gel base
Sodium fluoride (1426 ppm) + zinc base BDrug
Zinc base B, 1426ppm fluoride as sodium fluoride in a silica gel base
Fluoride (0 ppm)Drug
Non-zinc, 0ppm fluoride in a silica gel base

Study groups in NCT02195583
Study group	Role	What they receive
Sodium fluoride (1426 ppm)	Experimental	Non-zinc, 1426ppm fluoride as sodium fluoride in a silica gel base Receives: Drug: Sodium fluoride (1426 ppm)
Sodium fluoride (1150 ppm)	Experimental	Non-zinc, 1150ppm fluoride as sodium fluoride in a silica gel base Receives: Drug: Sodium fluoride (1150 ppm)
Sodium fluoride (250 ppm)	Experimental	Non-zinc, 250ppm fluoride as sodium fluoride in a silica gel base Receives: Drug: Sodium fluoride (250 ppm)
Sodium fluoride (1426 ppm) + zinc base A	Experimental	Zinc base A, 1426ppm fluoride as sodium fluoride in a silica gel base Receives: Drug: Sodium fluoride (1426 ppm) + zinc base A
Sodium fluoride (1426 ppm) + zinc base B	Experimental	Zinc base B, 1426ppm fluoride as sodium fluoride in a silica gel base Receives: Drug: Sodium fluoride (1426 ppm) + zinc base B
Fluoride (0 ppm)	Placebo comparator	Non-zinc, 0ppm fluoride in a silica gel base Receives: Drug: Fluoride (0 ppm)

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage Surface Microhardness Recovery (% SMHR)
Changes in the mineral content of the four centrally-located enamel specimens were evaluated using the Surface Microhardness (SMH) Test. The SMH was measured using a Wilson 2100 Hardness Tester. The baseline SMH was determined prior to the in vitro acid challenge. SMH was determined again after the in vitro acid challenge, after the in situ remineralization test, and again after the second in vitro acid challenge. The extent of remineralization was calculated as the % recovery in SMH using the equation: % SMHR= [(D1-R)/(D1-B)]*100 Where B = indentation length (μm) of sound enamel at baseline; D1 = indentation length (μm) after first acid challenge; R = indentation length (μm) after in situ remineralization.
Measured: Baseline to 4 hours

Secondary outcomes (3)

Enamel Fluoride Uptake
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 micrometer (μm) through the entire lesion (four cores per specimen). The enamel powder pooled from four drilling sample 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 microgram per square centimeter (μg/cm^2).
Measured: Baseline to 4 hours
Percentage Net Acid Resistance (% NAR)
Changes in the mineral content of the four centrally-located enamel specimens were evaluated using the SMH Test. The SMH was measured using a Wilson 2100 Hardness Tester. The baseline SMH was measured prior to the in vitro acid challenge. SMH was measured again after the in vitro acid challenge, after the in situ remineralization test, and again after the second in vitro acid challenge. The % NAR was calculated using the equation: % NAR= [(D1-D2)/(D1-B)]*100 where B= Indentation length (μm) of sound enamel at baseline; D1= Indentation length (μm) after first acid challenge and D2= Indentation length (μm) after second acid challenge.
Measured: Baseline to 4 hours
Percentage Comparative Acid Resistance (% CAR)
Changes in the mineral content of the four centrally-located enamel specimens were evaluated using the SMH Test. The SMH was measured using a Wilson 2100 Hardness Tester. The baseline SMH was measured prior to the in vitro acid challenge. SMH was measured again after the in vitro acid challenge, after the in situ remineralization test, and again after the second in vitro acid challenge. The % CAR was calculated using the equation: % CAR= [(D2-R)/(D1-B)]*100 where B= Indentation length (μm) of sound enamel at baseline; R= Indentation length (μm) of enamel after in situ remineralization; D1= Indentation length (μm) after first acid challenge; D2= Indentation length (μm) after second acid challenge.
Measured: Baseline to 4 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2014Aug 2014

First posted21 Jul 2014 (estimated)
Study startJun 2014
Primary completionAug 2014
Study completionAug 2014

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 Oral HygieneStudies 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 62 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02195583
Sponsor's protocol ID: 202194
Other IDs: RH02437
Status last verified: Mar 2015
First submitted: 17 Jul 2014
Last updated: 1 May 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis
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Not yet recruiting
Game-based Oral Health Promotion
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All Oral Hygiene trials

Study at a glance

From the registry record, last updated by the sponsor on 1 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Experimental Dentifrices on Remineralization of Caries Lesions In-situ
ClinicalTrials.gov ID: NCT02195583
Acronym / sponsor ID: 202194
Conditions: Oral Hygiene
Study type: Interventional
Recruitment status: Completed
Enrolment: 62 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Jun 2014
Primary completion: Aug 2014 (actual)
Study completion: Aug 2014 (actual)
First posted: 21 Jul 2014 (estimated)
Results: Posted 7 Apr 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Sodium fluoride (1426 ppm)	Experimental	Drug: Sodium fluoride (1426 ppm)Non-zinc, 1426ppm fluoride as sodium fluoride in a silica gel base
Sodium fluoride (1150 ppm)	Experimental	Drug: Sodium fluoride (1150 ppm)Non-zinc, 1150ppm fluoride as sodium fluoride in a silica gel base
Sodium fluoride (250 ppm)	Experimental	Drug: Sodium fluoride (250 ppm)Non-zinc, 250ppm fluoride as sodium fluoride in a silica gel base
Sodium fluoride (1426 ppm) + zinc base A	Experimental	Drug: Sodium fluoride (1426 ppm) + zinc base AZinc base A, 1426ppm fluoride as sodium fluoride in a silica gel base
Sodium fluoride (1426 ppm) + zinc base B	Experimental	Drug: Sodium fluoride (1426 ppm) + zinc base BZinc base B, 1426ppm fluoride as sodium fluoride in a silica gel base
Fluoride (0 ppm)	Placebo comparator	Drug: Fluoride (0 ppm)Non-zinc, 0ppm fluoride in a silica gel base

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Good general health with no clinically significant and relevant abnormalities of medical history or oral examination
Participants with maxillary dental arch suitable for the retention of the palatal appliance

Key exclusion criteria (2 listed)

Participants taking fluoride supplement
Pregnant or breast-feeding women

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 (1426 ppm)Non-zinc, 1426ppm fluoride as sodium fluoride in a silica gel base	Drug	Sodium fluoride (1426 ppm)
Sodium fluoride (1150 ppm)Non-zinc, 1150ppm fluoride as sodium fluoride in a silica gel base	Drug	Sodium fluoride (1150 ppm)
Sodium fluoride (250 ppm)Non-zinc, 250ppm fluoride as sodium fluoride in a silica gel base	Drug	Sodium fluoride (250 ppm)
Sodium fluoride (1426 ppm) + zinc base AZinc base A, 1426ppm fluoride as sodium fluoride in a silica gel base	Drug	Sodium fluoride (1426 ppm) + zinc base A
Sodium fluoride (1426 ppm) + zinc base BZinc base B, 1426ppm fluoride as sodium fluoride in a silica gel base	Drug	Sodium fluoride (1426 ppm) + zinc base B
Fluoride (0 ppm)Non-zinc, 0ppm fluoride in a silica gel base	Drug	Fluoride (0 ppm)

Primary outcome

Percentage Surface Microhardness Recovery (% SMHR)
Time frame: Baseline to 4 hours
Changes in the mineral content of the four centrally-located enamel specimens were evaluated using the Surface Microhardness (SMH) Test. The SMH was measured using a Wilson 2100 Hardness Tester. The baseline SMH was determined prior to the in vitro acid challenge. SMH was determined again after the in vitro acid challenge, after the in situ remineralization test, and again after the second in vitro acid challenge. The extent of remineralization was calculated as the % recovery in SMH using the equation: % SMHR= [(D1-R)/(D1-B)]*100 Where B = indentation length (μm) of sound enamel at baseline; D1 = indentation length (μm) after first acid challenge; R = indentation length (μm) after in situ remineralization.

3 secondary outcomes

Enamel Fluoride Uptake
Time frame: Baseline to 4 hours
Percentage Net Acid Resistance (% NAR)
Time frame: Baseline to 4 hours
Percentage Comparative Acid Resistance (% CAR)
Time frame: Baseline to 4 hours

Results and safety

Results posted to the registry on 7 Apr 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Overall Participants	62	53

Primary outcome: Percentage Surface Microhardness Recovery (% SMHR)

Time frame: Baseline to 4 hours. Least squares mean (Standard Error). Unit: Percentage of SMHR

Measure	Sodium Fluoride (1426 Ppm) n = 59	Sodium Fluoride (1150 Ppm) n = 57	Sodium Fluoride (250 Ppm) n = 55	Sodium Fluoride (1426 Ppm) + Zinc Base A n = 58	Sodium Fluoride (1426 Ppm) + Zinc Base B n = 60	Sodium Fluoride (0 Ppm) n = 59
Value	32.49 (1.167)	31.81 (1.182)	27.56 (1.199)	22.62 (1.175)	23.22 (1.159)	24.78 (1.167)

Sodium Fluoride (1426 Ppm) vs Sodium Fluoride (1150 Ppm) vs Sodium Fluoride (250 Ppm): p <0.0001, ANOVA
Sodium Fluoride (1426 Ppm) vs Sodium Fluoride (1150 Ppm) vs Sodium Fluoride (250 Ppm): p = 0.2274, ANOVA
Sodium Fluoride (1426 Ppm) vs Sodium Fluoride (1150 Ppm): Mean Difference (Net): 0.68 (95% CI -1.84 to 3.20), p = 0.5950, ANOVA

Population analysed: The primary population for the efficacy analysis was the Per Protocol (PP) population, including participants with a protocol violation affecting some (but not all) of the efficacy assessments. However, data from assessments when a violation occurred were excluded.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events (AEs) were collected from the start of the investigational product (or washout product) and until five days following last administration of the investigational product.Serious adverse events (SAEs) were collected over the same time period.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sodium Fluoride (1426 Ppm)	0 of 59 (0%)	3 of 59 (5.1%)	Not reported
Sodium Fluoride (1150 Ppm)	0 of 57 (0%)	1 of 57 (1.8%)	Not reported
Sodium Fluoride (250 Ppm)	0 of 55 (0%)	5 of 55 (9.1%)	Not reported
Sodium Fluoride (1426 Ppm) + Zinc Base A	0 of 58 (0%)	1 of 58 (1.7%)	Not reported
Sodium Fluoride (1426 Ppm) + Zinc Base B	1 of 60 (1.7%)	4 of 60 (6.7%)	Not reported
Sodium Fluoride (0 Ppm)	0 of 59 (0%)	5 of 59 (8.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2015.
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 Sodium fluoride (1426 ppm), Sodium fluoride (1150 ppm) and Sodium fluoride (250 ppm) in people with Oral Hygiene, 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 2 inclusion and 2 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 1 May 2015. 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 7 Apr 2015). 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) (time frame: Baseline to 4 hours). 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 NCT02195583.

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 1 May 2015.