Trial · NCT00762528
Compare Anti-inflammatory Dentifrices
NCT00762528, Phase 4, Completed, Colgate Palmolive; results first posted 2012-04-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Compare Anti-inflammatory Dentifrices. Trials, record NCT00762528. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00762528
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Compare Anti-inflammatory Dentifrices
- NCT number
- NCT00762528
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 49 participants, actual
- Lead sponsor
- Colgate Palmolive
- Conditions
- Gingivitis
- Interventions
- Triclosan/Copolymer/fluoride toothpaste, Sodium monofluorophosphate toothpaste
- First posted
- 2008-09-30
- Last updated
- 2015-09-10
- Results first posted
- 2012-04-03
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Gingival Index (GI) | 29 days | Gingival Index(GI)recorded on scale of 0-3 detailed below: 0=normal gingiva, 1=Mild inflammation(slight change in color, slight edema)no bleeding on palpation,2=Moderate inflammation(redness,edema,glazing)bleeding upon probing, 3=Severe inflammation(marked redness,edema)ulceration \& tendency to spontaneously bleed |
| Primary | Prostaglandin E2 (PGE2) | 29 days | Inflammatory biomarker found in gingival crevicular fluid (GCF). Higher Levels found in GCF may be a factor in tissue destruction as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis. |
| Primary | Interleukin - 1 Beta (IL-ß) | 29 days | Inflammatory biomarkers found in gingival crevicular fluid (GCF) that may be a factor in oral tissue destruction as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis. |
| Primary | Interleukin-6 (IL-6) | 29 days | Inflammatory biomarker found in gingival crevicular fluid (GCF). Higher Levels found in GCF may be a factor in tissue destruction as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis. |
| Primary | Nuclear Factor Kappa B Ligand (RANK-L) | 29 days | Receptor activator found in gingival crevicular fluid (GCF). Presence in GCF may indicate tissue damage as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis. |
| Primary | 8-iso-prostaglandinF2α (8-iso-PGF2α) | 29 days | Inflammatory biomarker found in gingival crevicular fluid (GCF). Presence in GCF may indicate tissue damage as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis. |
| Secondary | Dental Plaque Index (PI) | 29 days | measurement of supragingival dental plaque on scale of 0-3. 0=No plaque in gingival area,1=a film of plaque adhering to the free gingival margin and the adjacent tooth,2=Moderate accumulation of soft deposits within the gingival pocket and on the gingival margin and/or adjacent tooth-visible by the naked eye, 3=Abundance of soft matter within the gingival pocket and/or gingival margin and adjacent tooth surfaces. |
| Secondary | Bleeding on Probing (BOP) | 29 days | Presence or absence of bleeding to manual probing as a dichotomous variable as follows: 0 = No bleeding within 10 seconds after probing, 1 = Bleeding within 10 seconds after probing. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Gingival Index (GI) | 29 days | units on a scale | MEAN | |
| PRIMARY | Prostaglandin E2 (PGE2) | 29 days | pg/µl | LOG_MEAN | |
| PRIMARY | Interleukin - 1 Beta (IL-ß) | 29 days | pg/µl | LOG_MEAN | |
| SECONDARY | Dental Plaque Index (PI) | 29 days | Units on a scale | MEAN | |
| SECONDARY | Bleeding on Probing (BOP) | 29 days | Units on a scale | MEAN | |
| PRIMARY | Interleukin-6 (IL-6) | 29 days | pg/µl | LOG_MEAN | |
| PRIMARY | Nuclear Factor Kappa B Ligand (RANK-L) | 29 days | pg/µl | LOG_MEAN | |
| PRIMARY | 8-iso-prostaglandinF2α (8-iso-PGF2α) | 29 days | pg/µl | LOG_MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Gingival Index (GI) | Total Toothpaste | 1.04 | Standard Deviation 0.22 | units on a scale | |
| Gingival Index (GI) | Fluoride Toothpaste | 1.01 | Standard Deviation 0.19 | units on a scale | |
| Prostaglandin E2 (PGE2) | Total Toothpaste | 5.8 | Standard Deviation 2.7 | pg/µl | |
| Prostaglandin E2 (PGE2) | Fluoride Toothpaste | 5.2 | Standard Deviation 3 | pg/µl | |
| Interleukin - 1 Beta (IL-ß) | Total Toothpaste | 6.9 | Standard Deviation 0.8 | pg/µl | |
| Interleukin - 1 Beta (IL-ß) | Fluoride Toothpaste | 6.6 | Standard Deviation 1.2 | pg/µl | |
| Dental Plaque Index (PI) | Total Toothpaste | 1.69 | Standard Deviation 0.30 | Units on a scale | |
| Dental Plaque Index (PI) | Fluoride Toothpaste | 1.65 | Standard Deviation 0.35 | Units on a scale | |
| Bleeding on Probing (BOP) | Total Toothpaste | 0.24 | Standard Deviation 0.10 | Units on a scale | |
| Bleeding on Probing (BOP) | Fluoride Toothpaste | 0.26 | Standard Deviation 0.12 | Units on a scale |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Total Toothpaste | 24 | |
| Overall Study | STARTED | Fluoride Toothpaste | 25 | |
| Overall Study | COMPLETED | Total Toothpaste | 24 | |
| Overall Study | COMPLETED | Fluoride Toothpaste | 25 | |
| Overall Study | NOT COMPLETED | Total Toothpaste | 0 | |
| Overall Study | NOT COMPLETED | Fluoride Toothpaste | 0 |
Source ClinicalTrials.gov
Adverse events10
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 | Teeth Sensitive to cold | General disorders | Total Toothpaste | 0 | 24 | 0 |
| other | Teeth Sensitive to cold | General disorders | Fluoride Toothpaste | 2 | 25 | 2 |
| other | Oral Irritation | General disorders | Total Toothpaste | 0 | 24 | 0 |
| other | Oral Irritation | General disorders | Fluoride Toothpaste | 1 | 25 | 1 |
| other | chest cold, upper respiratory infection | General disorders | Total Toothpaste | 1 | 24 | 1 |
| other | chest cold, upper respiratory infection | General disorders | Fluoride Toothpaste | 1 | 25 | 1 |
| other | Pulled muscle in back | General disorders | Total Toothpaste | 0 | 24 | 0 |
| other | Pulled muscle in back | General disorders | Fluoride Toothpaste | 1 | 25 | 1 |
| other | Fever, chills & sore throat | General disorders | Total Toothpaste | 0 | 24 | 0 |
| other | Fever, chills & sore throat | General disorders | Fluoride Toothpaste | 1 | 25 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Total Toothpaste | ||
| Total, all-cause mortality | Fluoride Toothpaste | ||
| Total, other adverse events | Total Toothpaste | 1 | 24 |
| Total, other adverse events | Fluoride Toothpaste | 6 | 25 |
| Total, serious adverse events | Total Toothpaste | 0 | 24 |
| Total, serious adverse events | Fluoride Toothpaste | 0 | 25 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Total Toothpaste vs Fluoride Toothpaste: serious adverse events |
Source Trial comparisons
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/NCT00762528
GET https://conductscience.org/api/trials/v1/NCT00762528/registered