Trial · NCT02195583
The Effect of Experimental Dentifrices on Remineralization of Caries Lesions In-situ
NCT02195583, Not applicable, Completed, GlaxoSmithKline; results first posted 2015-04-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. The Effect of Experimental Dentifrices on Remineralization of Caries Lesions In-situ. Trials, record NCT02195583. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02195583
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Effect of Experimental Dentifrices on Remineralization of Caries Lesions In-situ
- NCT number
- NCT02195583
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 62 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Oral Hygiene
- Interventions
- 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, Fluoride (0 ppm)
- First posted
- 2014-07-21
- Last updated
- 2015-05-01
- Results first posted
- 2015-04-07
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage Surface Microhardness Recovery (% SMHR) | 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. |
| Secondary | Enamel Fluoride Uptake | Baseline to 4 hours | 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). |
| Secondary | Percentage Net Acid Resistance (% NAR) | Baseline to 4 hours | 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. |
| Secondary | Percentage Comparative Acid Resistance (% CAR) | Baseline to 4 hours | 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. |
Source ClinicalTrials.gov
Outcomes4
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) | Baseline to 4 hours | 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. | Percentage of SMHR | LEAST_SQUARES_MEAN |
| SECONDARY | Enamel Fluoride Uptake | Baseline to 4 hours | The main population for the secondary efficacy analysis was the 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. | microgram per square centimeter(μg/cm^2) | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage Net Acid Resistance (% NAR) | Baseline to 4 hours | The main population for the secondary efficacy analysis was the 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. | Percentage of NAR | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage Comparative Acid Resistance (% CAR) | Baseline to 4 hours | The main population for the secondary efficacy analysis was the 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. | Percentage of CAR | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group24
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) | Sodium Fluoride (1426 Ppm) | 32.49 | Standard Error 1.167 | Percentage of SMHR | |
| Percentage Surface Microhardness Recovery (% SMHR) | Sodium Fluoride (1150 Ppm) | 31.81 | Standard Error 1.182 | Percentage of SMHR | |
| Percentage Surface Microhardness Recovery (% SMHR) | Sodium Fluoride (250 Ppm) | 27.56 | Standard Error 1.199 | Percentage of SMHR | |
| Percentage Surface Microhardness Recovery (% SMHR) | Sodium Fluoride (1426 Ppm) + Zinc Base A | 22.62 | Standard Error 1.175 | Percentage of SMHR | |
| Percentage Surface Microhardness Recovery (% SMHR) | Sodium Fluoride (1426 Ppm) + Zinc Base B | 23.22 | Standard Error 1.159 | Percentage of SMHR | |
| Percentage Surface Microhardness Recovery (% SMHR) | Sodium Fluoride (0 Ppm) | 24.78 | Standard Error 1.167 | Percentage of SMHR | |
| Enamel Fluoride Uptake | Sodium Fluoride (1426 Ppm) | 2.94 | Standard Error 0.083 | microgram per square centimeter(μg/cm^2) | |
| Enamel Fluoride Uptake | Sodium Fluoride (1150 Ppm) | 2.70 | Standard Error 0.084 | microgram per square centimeter(μg/cm^2) | |
| Enamel Fluoride Uptake | Sodium Fluoride (250 Ppm) | 1.85 | Standard Error 0.085 | microgram per square centimeter(μg/cm^2) | |
| Enamel Fluoride Uptake | Sodium Fluoride (1426 Ppm) + Zinc Base A | 2.62 | Standard Error 0.083 | microgram per square centimeter(μg/cm^2) |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Overall Participants | 62 | |
| Overall Study | Sodium Fluoride (1150 Ppm) | Overall Participants | 57 | |
| Overall Study | Sodium Fluoride (0 Ppm) | Overall Participants | 59 | |
| Overall Study | Sodium Fluoride (1426 Ppm) + Zinc Base A | Overall Participants | 58 | |
| Overall Study | Sodium Fluoride (250 Ppm) | Overall Participants | 55 | |
| Overall Study | Sodium Fluoride (1426 Ppm) | Overall Participants | 59 | |
| Overall Study | Sodium Fluoride (1426 Ppm) + Zinc Base B | Overall Participants | 60 | |
| Overall Study | COMPLETED | Overall Participants | 53 | |
| Overall Study | NOT COMPLETED | Overall Participants | 9 |
Source ClinicalTrials.gov
Adverse events84
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 | Oral Mucosal Erythema | Gastrointestinal disorders | Sodium Fluoride (1426 Ppm) | 2 | 59 | |
| other | Oral Mucosal Erythema | Gastrointestinal disorders | Sodium Fluoride (1150 Ppm) | 0 | 57 | |
| other | Oral Mucosal Erythema | Gastrointestinal disorders | Sodium Fluoride (250 Ppm) | 0 | 55 | |
| other | Oral Mucosal Erythema | Gastrointestinal disorders | Sodium Fluoride (1426 Ppm) + Zinc Base A | 0 | 58 | |
| other | Oral Mucosal Erythema | Gastrointestinal disorders | Sodium Fluoride (1426 Ppm) + Zinc Base B | 1 | 60 | |
| other | Oral Mucosal Erythema | Gastrointestinal disorders | Sodium Fluoride (0 Ppm) | 2 | 59 | |
| other | Abdominal Discomfort | Gastrointestinal disorders | Sodium Fluoride (1426 Ppm) | 0 | 59 | |
| other | Abdominal Discomfort | Gastrointestinal disorders | Sodium Fluoride (1150 Ppm) | 0 | 57 | |
| other | Abdominal Discomfort | Gastrointestinal disorders | Sodium Fluoride (250 Ppm) | 1 | 55 | |
| other | Abdominal Discomfort | Gastrointestinal disorders | Sodium Fluoride (1426 Ppm) + Zinc Base A | 0 | 58 |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sodium Fluoride (1426 Ppm) | ||
| Total, all-cause mortality | Sodium Fluoride (1150 Ppm) | ||
| Total, all-cause mortality | Sodium Fluoride (250 Ppm) | ||
| Total, all-cause mortality | Sodium Fluoride (1426 Ppm) + Zinc Base A | ||
| Total, all-cause mortality | Sodium Fluoride (1426 Ppm) + Zinc Base B | ||
| Total, all-cause mortality | Sodium Fluoride (0 Ppm) | ||
| Total, other adverse events | Sodium Fluoride (1426 Ppm) | 3 | 59 |
| Total, other adverse events | Sodium Fluoride (1150 Ppm) | 1 | 57 |
| Total, other adverse events | Sodium Fluoride (250 Ppm) | 5 | 55 |
| Total, other adverse events | Sodium Fluoride (1426 Ppm) + Zinc Base A | 1 | 58 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 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/NCT02195583
GET https://conductscience.org/api/trials/v1/NCT02195583/results?page=2