Trial · NCT02751320
Efficacy of Three Toothpastes Using an in Situ Caries Model
NCT02751320, Not applicable, Completed, GlaxoSmithKline; results first posted 2017-10-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy of Three Toothpastes Using an in Situ Caries Model. Trials, record NCT02751320. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02751320
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of Three Toothpastes Using an in Situ Caries Model
- NCT number
- NCT02751320
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 58 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Dental Caries
- Interventions
- 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, 0.3%ZnCl2, 0.5% sodium citrate, 1150ppm F
- First posted
- 2016-04-26
- Last updated
- 2017-10-13
- Results first posted
- 2017-10-13
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage Surface Microhardness Recovery (SMHR) of Phyte (0% 0.425% and 0.85%) at 2 Weeks | 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. |
| Secondary | % 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 | 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 (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. |
| Secondary | Transverse Microradiography (TMR) Net Remineralization Change (ΔM) Value of Phytate (0% 0.452% and 0.85%) at 4 Weeks | Baseline upto 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). |
| Secondary | 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 | Baseline upto 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). |
| Secondary | Enamel Fluoride Uptake (EFU) of All Study Formulation Variables | At Week 2 | 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. |
| Secondary | Enamel Fluoride Uptake (EFU) of All Study Formulation Variables | At Week 4 | 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. |
Source ClinicalTrials.gov
Outcomes6
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 Phyte (0% 0.425% and 0.85%) at 2 Weeks | Baseline upto 2 weeks | Intent-to-treat (ITT) population, all participants who were randomized, received the study products at least once and provided at least one post-baseline assessment of efficacy. Number of participants who missed enamel specimens were: Test product 1- \[1\], Test product 2- \[1\], Reference Product 1- \[1\], and Reference Product 2- \[1\]. | % SMHR | MEAN |
| SECONDARY | % 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 | Baseline upto 2 weeks | ITT population, all participants who were randomized, received the study products at least once and provided at least one post-baseline assessment of efficacy. Number of participants who missed enamel specimens were: Test product 2- \[1\], Test product 3- \[2\], Reference Product 2- \[1\], and Reference Product 3- \[1\]. | % SMHR | MEAN |
| SECONDARY | Transverse Microradiography (TMR) Net Remineralization Change (ΔM) Value of Phytate (0% 0.452% and 0.85%) at 4 Weeks | Baseline upto 4 weeks | ITT population, all participants who were randomized, received the study products at least once and provided at least one post-baseline assessment of efficacy. Number of participants who missed enamel specimens were: Test product 1- \[1\], Test product 2- \[1\], and Reference Product 2- \[1\]. | [%vol mineral x µm | MEAN |
| SECONDARY | 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 | Baseline upto 4 weeks | ITT population, all participants who were randomized, received the study products at least once and provided at least one post-baseline assessment of efficacy. Number of participants who missed enamel specimens were: Test product 2 - \[1\], Test product 3 - \[2\], Reference Product 2 - \[1\] and Reference Product 3 \[1\]. | [%vol mineral x µm | MEAN |
| SECONDARY | Enamel Fluoride Uptake (EFU) of All Study Formulation Variables | At Week 2 | ITT population, all participants who were randomized, received the study products at least once and provided at least one post-baseline assessment of efficacy. Number of participants who missed enamel specimens were: Test product1-\[1\], Test product2-\[1\], Test product3-\[2\], Reference Product1-\[1\], Reference Product2-\[1\] and Reference Product3-\[1\]. | μg/cm^2 | MEAN |
| SECONDARY | Enamel Fluoride Uptake (EFU) of All Study Formulation Variables | At Week 4 | ITT population, all participants who were randomized, received the study products at least once and provided at least one post-baseline assessment of efficacy. Number of participants who missed enamel specimens were: Test product1-\[1\], Test product2-\[2\], Test product3-\[3\], Reference Product1-\[1\], Reference Product2-\[1\] and Reference Product3-\[1\]. | μg/cm^2 | MEAN |
Source ClinicalTrials.gov
Results by group28
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 Phyte (0% 0.425% and 0.85%) at 2 Weeks | Test Product 1 | 25.53 | Standard Deviation 21.513 | % SMHR | |
| Percentage Surface Microhardness Recovery (SMHR) of Phyte (0% 0.425% and 0.85%) at 2 Weeks | Test Product 2 | 26.81 | Standard Deviation 18.059 | % SMHR | |
| Percentage Surface Microhardness Recovery (SMHR) of Phyte (0% 0.425% and 0.85%) at 2 Weeks | Reference Product 1 | 7.41 | Standard Deviation 18.648 | % SMHR | |
| Percentage Surface Microhardness Recovery (SMHR) of Phyte (0% 0.425% and 0.85%) at 2 Weeks | Reference Product 2 | 28.88 | Standard Deviation 21.046 | % SMHR | |
% 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 | Test Product 2 | 26.81 | Standard Deviation 18.059 | % SMHR | |
% 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 | Test Product 3 | 23.38 | Standard Deviation 20.177 | % SMHR | |
% 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 | Reference Product 2 | 28.88 | Standard Deviation 21.046 | % SMHR | |
% 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 | Reference Product 3 | 28.80 | Standard Deviation 20.830 | % SMHR | |
| Transverse Microradiography (TMR) Net Remineralization Change (ΔM) Value of Phytate (0% 0.452% and 0.85%) at 4 Weeks | Test Product 1 | 3055.36 | Standard Deviation 1459.283 | [%vol mineral x µm | |
| Transverse Microradiography (TMR) Net Remineralization Change (ΔM) Value of Phytate (0% 0.452% and 0.85%) at 4 Weeks | Test Product 2 | 2772.96 | Standard Deviation 989.567 | [%vol mineral x µm |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 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 Study | 45 | |
| Overall Study | Received Test Product 1 | Overall Study | 29 | |
| Overall Study | Received Test Prodcut 2 | Overall Study | 28 | |
| Overall Study | Received Test Prodcut 3 | Overall Study | 28 | |
| Overall Study | Received Reference Product 1 | Overall Study | 29 | |
| Overall Study | Received Reference Product 2 | Overall Study | 28 | |
| Overall Study | Received Reference Product 3 | Overall Study | 28 | |
| Overall Study | COMPLETED | Overall Study | 42 | |
| Overall Study | NOT COMPLETED | Overall Study | 3 |
Source ClinicalTrials.gov
Adverse events234
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 | GINGIVAL ERYTHEMA | Gastrointestinal disorders | Test Product 1 | 2 | 28 | |
| other | GINGIVAL ERYTHEMA | Gastrointestinal disorders | Test Product 2 | 3 | 28 | |
| other | GINGIVAL ERYTHEMA | Gastrointestinal disorders | Test Product 3 | 2 | 28 | |
| other | GINGIVAL ERYTHEMA | Gastrointestinal disorders | Reference Product 1 | 1 | 29 | |
| other | GINGIVAL ERYTHEMA | Gastrointestinal disorders | Reference Product 2 | 1 | 27 | |
| other | GINGIVAL ERYTHEMA | Gastrointestinal disorders | Reference Product 3 | 1 | 28 | |
| other | Mouth ulceration | Gastrointestinal disorders | Test Product 1 | 2 | 28 | |
| other | Mouth ulceration | Gastrointestinal disorders | Test Product 2 | 1 | 28 | |
| other | Mouth ulceration | Gastrointestinal disorders | Test Product 3 | 1 | 28 | |
| other | Mouth ulceration | Gastrointestinal disorders | Reference Product 1 | 1 | 29 |
1 to 10 of 234Source ClinicalTrials.gov
See all 234 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Test Product 1 | 0 | 28 |
| Total, all-cause mortality | Test Product 2 | 0 | 28 |
| Total, all-cause mortality | Test Product 3 | 0 | 28 |
| Total, all-cause mortality | Reference Product 1 | 0 | 29 |
| Total, all-cause mortality | Reference Product 2 | 0 | 27 |
| Total, all-cause mortality | Reference Product 3 | 0 | 28 |
| Total, other adverse events | Test Product 1 | 9 | 28 |
| Total, other adverse events | Test Product 2 | 9 | 28 |
| Total, other adverse events | Test Product 3 | 10 | 28 |
| Total, other adverse events | Reference Product 1 | 7 | 29 |
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
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The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02751320
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