An interventional study of Test Dentifrice and Reference Dentifrice in Tooth Erosion, sponsored by GlaxoSmithKline. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-01-18.
Sponsored by GlaxoSmithKline · Not applicable, Interventional, and Basic science
The aim of this study is to assess the impact of formulation differences on fluoride retention clearance with US levels of fluoride (1150 ppm of fluoride) by evaluating and comparing between treatments the concentrations of fluoride and calcium ions in saliva over 60 minutes after a single brushing with US marketed fluoridated dentifrices and following a dietary acid challenge post 60 minutes of brushing with study treatment.
47 studies on the registry are indexed under Tooth Erosion; 7 are open to participants now.
This study's enrollment of 29 is below the median of 33 across 33 interventional studies indexed under Tooth Erosion.
Browse Tooth Erosion studies →GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 118 are open to participants now.
Of its 264 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
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Good general and mental health with, in the opinion of the investigator or medically qualified designee:
Exclusion Criteria:
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
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Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
Other: Test Dentifrice · Other: Orange Juice · Other: De-ionised water
1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL water rinse
Other: Reference Dentifrice · Other: De-ionised water
1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
Other: Comparator Dentifrice · Other: Orange Juice · Other: De-ionised water
Marketed dentifrice containing 1150ppm fluoride and 5% w/w KNO3
Marketed dentifrice containing 1150ppm fluoride and 5% w/w KNO3
Marketed dentifrice containing 1150ppm fluoride and 5% w/w KNO3
Teeth will be rinsed with orange juice followed by rinsing with de-ionised water in test dentifrice and comparator dentifrice arms.
Teeth will be rinsed with de-ionised water followed by reference dentifrice and followed by rinsing with orange juice in test dentifrice and comparator dentifrice arms.
Concentrations of Fluoride Ions in Saliva 60 Minutes Post Brushing Prior to Administration of the Orange Juice or De-ionised Water Rinse
Concentration of fluoride ions in saliva at 60 minutes after a single brushing with a fluoride dentifrice prior to rinsing with either de-ionised (DI) water or orange juice (OJ). Descriptive data is presented as least square (LS) mean and standard error (SE). SE for Fluoride is the SE of the raw mean.
Time frame: 60 minutes
Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse
Concentration of fluoride and calcium ions in saliva at baseline, 1, 5, 10, 15, 30 and 60 minutes (for calcium only) after a single brushing with a fluoride dentifrice
Time frame: up to 60 minutes
Concentrations of Fluoride and Calcium Ions in Saliva Following Administration of the Orange Juice or De-ionised Water Rinse
Concentration of fluoride and calcium ions in saliva following a rinse with either de ionised water or OJ 60 minutes after a single brushing with a fluoride dentifrice
Time frame: 60 minutes
Concentrations of Fluoride and Calcium Ions in the Initial Expectorate, De-ionised Water Rinse Post Brushing Expectorate, and 60 Minutes Post Brushing Following Administration of Orange Juice or De-ionised Water Rinse
Concentration of fluoride and calcium ions in the initial expectorate, de-ionized water rinse post brushing expectorate, and 60 minutes post brushing following administration of orange juice or de-ionised water rinse
Time frame: up to 60 minutes
Participants were recruited at one Centre United Kingdom.
| Milestone | Sequence 1: Test/Comparator/Reference: Dentifrice | Sequence 2: Test/Reference/Comparator: Dentifrice | Sequence 3: Comparator/Test/Reference: Dentifrice | Sequence 4: Comparator/Reference/Test: Dentifrice | Sequence 5: Reference/Test/Comparator: Dentifrice | Sequence 6: Reference/Comparator/Test: Dentifrice |
|---|---|---|---|---|---|---|
| Started | 5 | 5 | 4 | 5 | 5 | 5 |
| Completed | 5 | 5 | 4 | 5 | 5 | 5 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Sequence 1: Test/Comparator/Reference: Dentifrice | Sequence 2: Test/Reference/Comparator: Dentifrice | Sequence 3: Comparator/Test/Reference: Dentifrice | Sequence 4: Comparator/Reference/Test: Dentifrice | Sequence 5: Reference/Test/Comparator: Dentifrice | Sequence 6: Reference/Comparator/Test: Dentifrice |
|---|---|---|---|---|---|---|
| Started | 5 | 5 | 4 | 5 | 5 | 5 |
| Completed | 5 | 5 | 4 | 5 | 4 | 5 |
| Not completed | 0 | 0 | 0 | 0 | 1 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 0 | 1 | 0 |
| Milestone | Sequence 1: Test/Comparator/Reference: Dentifrice | Sequence 2: Test/Reference/Comparator: Dentifrice | Sequence 3: Comparator/Test/Reference: Dentifrice | Sequence 4: Comparator/Reference/Test: Dentifrice | Sequence 5: Reference/Test/Comparator: Dentifrice | Sequence 6: Reference/Comparator/Test: Dentifrice |
|---|---|---|---|---|---|---|
| Started | 5 | 5 | 4 | 5 | 4 | 5 |
| Completed | 5 | 5 | 4 | 5 | 4 | 5 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Sequence 1: Test/Comparator/Reference: Dentifrice | Sequence 2: Test/Reference/Comparator: Dentifrice | Sequence 3: Comparator/Test/Reference: Dentifrice | Sequence 4: Comparator/Reference/Test: Dentifrice | Sequence 5: Reference/Test/Comparator: Dentifrice | Sequence 6: Reference/Comparator/Test: Dentifrice |
|---|---|---|---|---|---|---|
| Started | 5 | 5 | 4 | 5 | 4 | 5 |
| Completed | 5 | 5 | 4 | 5 | 4 | 5 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Sequence 1: Test/Comparator/Reference: Dentifrice | Sequence 2: Test/Reference/Comparator: Dentifrice | Sequence 3: Comparator/Test/Reference: Dentifrice | Sequence 4: Comparator/Reference/Test: Dentifrice | Sequence 5: Reference/Test/Comparator: Dentifrice | Sequence 6: Reference/Comparator/Test: Dentifrice |
|---|---|---|---|---|---|---|
| Started | 5 | 5 | 4 | 5 | 4 | 5 |
| Completed | 5 | 5 | 4 | 5 | 4 | 5 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
Concentration of fluoride ions in saliva at 60 minutes after a single brushing with a fluoride dentifrice prior to rinsing with either de-ionised (DI) water or orange juice (OJ). Descriptive data is presented as least square (LS) mean and standard error (SE). SE for Fluoride is the SE of the raw mean.
| parts per million(ppm) | Test Dentifrice | Reference Dentifrice | Comparator Dentifrice |
|---|---|---|---|
| Concentrations of Fluoride Ions in Saliva 60 Minutes Post Brushing Prior to Administration of the Orange Juice or De-ionised Water Rinse | 0.23 ± 0.0469 | 0.23 ± 0.0430 | 0.15 ± 0.0485 |
Concentration of fluoride and calcium ions in saliva at baseline, 1, 5, 10, 15, 30 and 60 minutes (for calcium only) after a single brushing with a fluoride dentifrice
| ppm | Test Dentifrice | Reference Dentifrice | Comparator Dentifrice |
|---|---|---|---|
| Fluoride: At baseline (n=26, 28, 26) | 0.045 ± 0.0125 | 0.032 ± 0.0084 | 0.031 ± 0.0072 |
| Fluoride: At 1 minute (n=27, 28, 26) | 8.775 ± 0.8301 | 8.794 ± 1.0562 | 7.630 ± 0.7497 |
| Fluoride: At 5 minute (n=27, 27, 27) | 3.881 ± 0.4115 | 4.132 ± 0.4759 | 3.492 ± 0.4664 |
| Fluoride: At 10 minute (n=26, 26, 26) | 1.831 ± 0.1980 | 1.951 ± 0.2654 | 1.476 ± 0.1524 |
| Fluoride: At 15 minute (n=27, 27, 26) | 1.346 ± 0.1827 | 1.188 ± 0.1550 | 0.942 ± 0.1432 |
| Fluoride: At 30 minute (n=26, 27, 27) | 0.656 ± 0.1065 | 0.600 ± 0.0810 | 0.479 ± 0.0723 |
| Calcium: At Baseline (n=26, 25, 22) | 29.749 ± 0.9428 | 28.357 ± 1.0162 | 28.661 ± 1.0657 |
| Calcium: At 1 minute (n=23, 28, 25) | 28.300 ± 1.5171 | 27.217 ± 1.0689 | 14.931 ± 1.0999 |
| Calcium: At 5 minute (n=16, 17, 22) | 27.818 ± 1.3743 | 26.070 ± 1.4638 | 17.227 ± 0.9170 |
| Calcium: At 10 minute (n=16, 16, 21) | 27.472 ± 1.0061 | 25.672 ± 1.1944 | 20.133 ± 1.0395 |
| Calcium: At 15 minute (n=18, 20, 20) | 28.319 ± 1.0783 | 27.227 ± 0.8656 | 23.761 ± 1.2803 |
| Calcium: At 30 minute (n=17, 18, 20) | 28.650 ± 1.0725 | 27.323 ± 1.0325 | 24.196 ± 1.3196 |
| Calcium: At 60 minute (n=23, 20, 22) | 28.198 ± 1.0073 | 27.094 ± 1.0560 | 27.104 ± 1.3777 |
Concentration of fluoride and calcium ions in saliva following a rinse with either de ionised water or OJ 60 minutes after a single brushing with a fluoride dentifrice
| ppm | Test Dentifrice | Reference Dentifrice | Comparator Dentifrice |
|---|---|---|---|
| Fluoride Ion concentration(n=27, 28, 27) | 0.349 ± 0.0349 | 0.169 ± 0.1104 | 0.277 ± 0.1601 |
| Calcium Ion concentration (n=26, 22, 25) | 15.015 ± 4.3355 | 27.263 ± 4.7113 | 14.805 ± 4.0473 |
Concentration of fluoride and calcium ions in the initial expectorate, de-ionized water rinse post brushing expectorate, and 60 minutes post brushing following administration of orange juice or de-ionised water rinse
| ppm | Test Dentifrice | Reference Dentifrice | Comparator Dentifrice |
|---|---|---|---|
| Fluoride: In initial expectorate | 178.522 ± 61.1593 | 168.728 ± 54.3780 | 164.708 ± 54.2632 |
| Fluoride: Post-Brushing De-Ionised Water Rinse Ex | 8.377 ± 4.2346 | 7.721 ± 4.1721 | 7.443 ± 3.4546 |
| Fluoride: 60 Minutes Post Brushing | 0.166 ± 0.0609 | 0.046 ± 0.0370 | 0.135 ± 0.0563 |
| Calcium: In initial expectorate | 17.096 ± 4.7864 | 17.467 ± 4.1241 | 2.500 ± 0.0000 |
| Calcium: Post-Brushing De-Ionised Water Rinse Ex | 4.959 ± 2.2712 | 4.438 ± 2.2141 | 2.500 ± 0.0000 |
| Calcium: 60 Minutes Post Brushing | 96.165 ± 9.2357 | 4.600 ± 2.0507 | 99.189 ± 17.2771 |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Test Dentifrice | — | 0/28 (0%) | 8/28 (28.6%) |
| Reference Dentifrice | — | 0/29 (0%) | 3/29 (10.3%) |
| Comparator Dentifrice | — | 0/28 (0%) | 5/28 (17.9%) |
| Event | Test Dentifrice | Reference Dentifrice | Comparator Dentifrice |
|---|---|---|---|
| Oral herpesInfections and infestations | 0/28 | 0/29 | 2/28 |
| Mouth injuryInjury, poisoning and procedural complications | 2/28 | 0/29 | 1/28 |
| Chapped LipsGastrointestinal disorders | 1/28 | 0/29 | 0/28 |
| NauseaGastrointestinal disorders | 1/28 | 0/29 | 0/28 |
| Device failureGeneral disorders | 1/28 | 0/29 | 0/28 |
| Medical device complicationGeneral disorders | 1/28 | 0/29 | 0/28 |
| InfluenzaInfections and infestations | 0/28 | 0/29 | 1/28 |
| RhinitisInfections and infestations | 0/28 | 0/29 | 1/28 |
| HeadacheNervous system disorders | 1/28 | 0/29 | 1/28 |
| Oropharyngeal PainRespiratory, thoracic and mediastinal disorders | 1/28 | 0/29 | 0/28 |
| Age, Continuous(Years) | Overall Study |
|---|---|
| Mean | 34.8 ± 9.12 |
| Gender(Participants) | Overall Study |
|---|---|
| Female | 23 |
| Male | 6 |
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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