Trial · NCT02243046
The Clinical Investigation of a Zinc Based Toothpaste in Reducing Plaque and Gingivitis
NCT02243046, Phase 2, Completed, Colgate Palmolive; results first posted 2016-05-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Clinical Investigation of a Zinc Based Toothpaste in Reducing Plaque and Gingivitis. Trials, record NCT02243046. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02243046
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Clinical Investigation of a Zinc Based Toothpaste in Reducing Plaque and Gingivitis
- NCT number
- NCT02243046
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 162 participants, actual
- Lead sponsor
- Colgate Palmolive
- Conditions
- Dental Plaque and Gingivitis
- Interventions
- Control toothpaste, Experimental toothpaste, Active Comparator
- First posted
- 2014-09-17
- Last updated
- 2019-02-25
- Results first posted
- 2016-05-04
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Gingivitis Scores | Baseline | Gingivitis scale (Loe \& Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding) |
| Primary | Gingivitis Scores | 3 months (from Baseline) | Gingivitis scale (Loe \& Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding) |
| Primary | Gingivitis Scores | 6 months (from Baseline) | Gingivitis scale (Loe \& Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding) |
| Primary | Dental Plaque Scores | Baseline | Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth) |
| Primary | Dental Plaque Scores | 3 months (from Baseline) | Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth) |
| Primary | Dental Plaque Scores | 6 months (from Baseline) | Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth) |
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 | Gingivitis Scores | Baseline | units on a scale | MEAN | |
| PRIMARY | Gingivitis Scores | 3 months (from Baseline) | units on a scale | MEAN | |
| PRIMARY | Gingivitis Scores | 6 months (from Baseline) | units on a scale | MEAN | |
| PRIMARY | Dental Plaque Scores | Baseline | units on a scale | MEAN | |
| PRIMARY | Dental Plaque Scores | 3 months (from Baseline) | units on a scale | MEAN | |
| PRIMARY | Dental Plaque Scores | 6 months (from Baseline) | units on a scale | 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 |
|---|---|---|---|---|---|
| Gingivitis Scores | Control Toothpaste | 1.48 | Standard Deviation 0.23 | units on a scale | |
| Gingivitis Scores | Experimental Toothpaste | 1.57 | Standard Deviation 0.28 | units on a scale | |
| Gingivitis Scores | Active Comparator | 1.49 | Standard Deviation 0.20 | units on a scale | |
| Gingivitis Scores | Control Toothpaste | 1.46 | Standard Deviation 0.19 | units on a scale | |
| Gingivitis Scores | Experimental Toothpaste | 1.33 | Standard Deviation 0.23 | units on a scale | |
| Gingivitis Scores | Active Comparator | 1.25 | Standard Deviation 0.18 | units on a scale | |
| Gingivitis Scores | Control Toothpaste | 1.44 | Standard Deviation 0.20 | units on a scale | |
| Gingivitis Scores | Experimental Toothpaste | 1.23 | Standard Deviation 0.23 | units on a scale | |
| Gingivitis Scores | Active Comparator | 1.19 | Standard Deviation 0.17 | units on a scale | |
| Dental Plaque Scores | Control Toothpaste | 2.91 | Standard Deviation 0.24 | units on a scale |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Control Toothpaste | 55 | |
| Overall Study | STARTED | Experimental Toothpaste | 54 | |
| Overall Study | STARTED | Active Comparator | 53 | |
| Overall Study | 3 Month | Control Toothpaste | 54 | |
| Overall Study | 3 Month | Experimental Toothpaste | 53 | |
| Overall Study | 3 Month | Active Comparator | 51 | |
| Overall Study | 6 Month | Control Toothpaste | 54 | |
| Overall Study | 6 Month | Experimental Toothpaste | 53 | |
| Overall Study | 6 Month | Active Comparator | 49 | |
| Overall Study | COMPLETED | Control Toothpaste | 54 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Control Toothpaste | ||
| Total, all-cause mortality | Experimental Toothpaste | ||
| Total, all-cause mortality | Active Comparator | ||
| Total, other adverse events | Control Toothpaste | 0 | 55 |
| Total, other adverse events | Experimental Toothpaste | 0 | 54 |
| Total, other adverse events | Active Comparator | 0 | 53 |
| Total, serious adverse events | Control Toothpaste | 0 | 55 |
| Total, serious adverse events | Experimental Toothpaste | 0 | 54 |
| Total, serious adverse events | Active Comparator | 0 | 53 |
Source ClinicalTrials.gov
Papers0
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/NCT02243046
GET https://conductscience.org/api/trials/v1/NCT02243046/registered