Trial · NCT02399163
Evaluation of Oral Hygiene Products in an In Situ Caries Model
NCT02399163, Not applicable, Completed, GlaxoSmithKline; results first posted 2016-05-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluation of Oral Hygiene Products in an In Situ Caries Model. Trials, record NCT02399163. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02399163
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Oral Hygiene Products in an In Situ Caries Model
- NCT number
- NCT02399163
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 80 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Dental Caries
- Interventions
- Fluoride free toothpaste, Fluoride toothpaste, Fluoride mouthwash
- First posted
- 2015-03-26
- Last updated
- 2016-05-12
- Results first posted
- 2016-05-12
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage Surface Microhardness Recovery (%SMHR) of Placebo Dentifrice/Fluoride Rinse Compared to Placebo Dentifrice/No Rinse | Baseline to 14 days | SMHR test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was performed ex-vivo 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. |
| Secondary | Percentage Surface Microhardness Recovery (SMHR) of Placebo Dentifrice/Fluoride Rinse, Placebo Dentifrice/No Rinse, Fluoride Dentifrice/No Rinse and Fluoride Dentifrice/Fluoride Rinse | Baseline to 14 days | SMHR test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was performed ex-vivo 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 rehardening 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. |
| Secondary | Enamel Fluoride Uptake | Baseline to 14 days | 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 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 microgram per square centimeter (μg/cm\^2). |
| Secondary | Change in Saliva Fluoride Concentration From Baseline (Pre-treatment) to Day 14 | Baseline to Day14 | Fluoride concentration in saliva was measured after collecting saliva samples at the following time points: - at Day 1 baseline prior to supervised treatment. - at day 1 post supervised treatment at site. - at Day 14 post treatment. The amount of fluoride in the samples was calculated based on the amount of fluoride divided by the volume of the sample and expressed as μg/mL of sample. |
| Secondary | Change in Saliva Fluoride Concentration From Baseline (Post-treatment) to Day 14 | Baseline up to Day 14 | Fluoride concentration in saliva was measured after collecting saliva samples at the following time points: - at Day 1 post supervised treatment at site. - at Day 14 post treatment. The amount of fluoride in the samples was calculated based on the amount of fluoride divided by the volume of the sample and expressed as μg/mL of sample. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage Surface Microhardness Recovery (%SMHR) of Placebo Dentifrice/Fluoride Rinse Compared to Placebo Dentifrice/No Rinse | Baseline to 14 days | Per-protocol (PP) population included all participants who were randomized into the study, received at least one dose of study product, had at least one post-baseline efficacy assessment and had no protocol violations deemed to affect efficacy during the study. | % SMHR | MEAN |
| SECONDARY | Percentage Surface Microhardness Recovery (SMHR) of Placebo Dentifrice/Fluoride Rinse, Placebo Dentifrice/No Rinse, Fluoride Dentifrice/No Rinse and Fluoride Dentifrice/Fluoride Rinse | Baseline to 14 days | PP population included all participants who were randomized into the study, received at least one dose of study product, had at least one post-baseline efficacy assessment and had no protocol violations deemed to affect efficacy during the study. | % SMHR | MEAN |
| SECONDARY | Enamel Fluoride Uptake | Baseline to 14 days | PP population included all participants who were randomized into the study, received at least one dose of study product, had at least one post-baseline efficacy assessment and had no protocol violations deemed to affect efficacy during the study. | microgram per square centimeter(μg/cm^2) | MEAN |
| SECONDARY | Change in Saliva Fluoride Concentration From Baseline (Pre-treatment) to Day 14 | Baseline to Day14 | PP population included all participants who were randomized into the study, received at least one dose of study product, had at least one post-baseline efficacy assessment and had no protocol violations deemed to affect efficacy during the study. | microgram per mililitre(μg/mL ) | MEAN |
| SECONDARY | Change in Saliva Fluoride Concentration From Baseline (Post-treatment) to Day 14 | Baseline up to Day 14 | PP population included all participants who were randomized into the study, received at least one dose of study product, had at least one post-baseline efficacy assessment and had no protocol violations deemed to affect efficacy during the study. | μg/mL | MEAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage Surface Microhardness Recovery (%SMHR) of Placebo Dentifrice/Fluoride Rinse Compared to Placebo Dentifrice/No Rinse | Placebo Dentifrice/Fluoride Rinse | 24.48 | Standard Deviation 16.088 | % SMHR | |
| Percentage Surface Microhardness Recovery (%SMHR) of Placebo Dentifrice/Fluoride Rinse Compared to Placebo Dentifrice/No Rinse | Placebo Dentifrice/No Rinse | 8.09 | Standard Deviation 25.892 | % SMHR | |
| Percentage Surface Microhardness Recovery (SMHR) of Placebo Dentifrice/Fluoride Rinse, Placebo Dentifrice/No Rinse, Fluoride Dentifrice/No Rinse and Fluoride Dentifrice/Fluoride Rinse | Placebo Dentifrice/Fluoride Rinse | 24.48 | Standard Deviation 16.088 | % SMHR | |
| Percentage Surface Microhardness Recovery (SMHR) of Placebo Dentifrice/Fluoride Rinse, Placebo Dentifrice/No Rinse, Fluoride Dentifrice/No Rinse and Fluoride Dentifrice/Fluoride Rinse | Placebo Dentifrice/No Rinse | 8.09 | Standard Deviation 25.892 | % SMHR | |
| Percentage Surface Microhardness Recovery (SMHR) of Placebo Dentifrice/Fluoride Rinse, Placebo Dentifrice/No Rinse, Fluoride Dentifrice/No Rinse and Fluoride Dentifrice/Fluoride Rinse | Fluoride Dentifrice/No Rinse | 28.36 | Standard Deviation 21.037 | % SMHR | |
| Percentage Surface Microhardness Recovery (SMHR) of Placebo Dentifrice/Fluoride Rinse, Placebo Dentifrice/No Rinse, Fluoride Dentifrice/No Rinse and Fluoride Dentifrice/Fluoride Rinse | Fluoride Dentifrice/Fluoride Rinse | 30.01 | Standard Deviation 18.203 | % SMHR | |
| Enamel Fluoride Uptake | Placebo Dentifrice/Fluoride Rinse | 7.22 | Standard Deviation 3.016 | microgram per square centimeter(μg/cm^2) | |
| Enamel Fluoride Uptake | Placebo Dentifrice/No Rinse | 1.60 | Standard Deviation 0.670 | microgram per square centimeter(μg/cm^2) | |
| Enamel Fluoride Uptake | Fluoride Dentifrice/No Rinse | 8.01 | Standard Deviation 3.925 | microgram per square centimeter(μg/cm^2) | |
| Enamel Fluoride Uptake | Fluoride Dentifrice/Fluoride Rinse | 9.97 | Standard Deviation 4.962 | microgram per square centimeter(μg/cm^2) |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Overall Study | 62 | |
| Overall Study | COMPLETED | Overall Study | 53 | |
| Overall Study | NOT COMPLETED | Overall Study | 9 |
Source ClinicalTrials.gov
Adverse events204
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Glossodynia | Gastrointestinal disorders | Placebo Dentifrice/Fluoride Rinse | 0 | 60 | |
| other | Glossodynia | Gastrointestinal disorders | Placebo Dentifrice/No Rinse | 2 | 56 | |
| other | Glossodynia | Gastrointestinal disorders | Fluoride Dentifrice/No Rinse | 1 | 59 | |
| other | Glossodynia | Gastrointestinal disorders | Fluoride Dentifrice/Fluoride Rinse | 2 | 57 | |
| other | Tongue Geographic | Gastrointestinal disorders | Placebo Dentifrice/Fluoride Rinse | 0 | 60 | |
| other | Tongue Geographic | Gastrointestinal disorders | Placebo Dentifrice/No Rinse | 0 | 56 | |
| other | Tongue Geographic | Gastrointestinal disorders | Fluoride Dentifrice/No Rinse | 0 | 59 | |
| other | Tongue Geographic | Gastrointestinal disorders | Fluoride Dentifrice/Fluoride Rinse | 2 | 57 | |
| other | Dry Mouth | Gastrointestinal disorders | Placebo Dentifrice/Fluoride Rinse | 0 | 60 | |
| other | Dry Mouth | Gastrointestinal disorders | Placebo Dentifrice/No Rinse | 0 | 56 |
1 to 10 of 204Source ClinicalTrials.gov
See all 204 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo Dentifrice/Fluoride Rinse | ||
| Total, all-cause mortality | Placebo Dentifrice/No Rinse | ||
| Total, all-cause mortality | Fluoride Dentifrice/No Rinse | ||
| Total, all-cause mortality | Fluoride Dentifrice/Fluoride Rinse | ||
| Total, other adverse events | Placebo Dentifrice/Fluoride Rinse | 15 | 60 |
| Total, other adverse events | Placebo Dentifrice/No Rinse | 13 | 56 |
| Total, other adverse events | Fluoride Dentifrice/No Rinse | 18 | 59 |
| Total, other adverse events | Fluoride Dentifrice/Fluoride Rinse | 17 | 57 |
| Total, serious adverse events | Placebo Dentifrice/Fluoride Rinse | 1 | 60 |
| Total, serious adverse events | Placebo Dentifrice/No Rinse | 1 | 56 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02399163
GET https://conductscience.org/api/trials/v1/NCT02399163/events?page=2