Trial · NCT01021007
Clinical Research Study Efficacy of a Prototype Oral Rinse
NCT01021007, Phase 3, Completed, Colgate Palmolive; results first posted 2009-11-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clinical Research Study Efficacy of a Prototype Oral Rinse. Trials, record NCT01021007. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01021007
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Research Study Efficacy of a Prototype Oral Rinse
- NCT number
- NCT01021007
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 67 participants, actual
- Lead sponsor
- Colgate Palmolive
- Conditions
- Dental Plaque
- Interventions
- Iodine, water
- First posted
- 2009-11-26
- Last updated
- 2009-12-01
- Results first posted
- 2009-11-26
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Gingival Index | 6 weeks | 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 | EIBI Bleeding Score: Eastman Indterdental Bleeding Index Scale | 6 weeks | 0 = no bleeding or 1=spontaneous bleeding. Both upper and lower gums around each tooth in the mouth are checked for bleeding sites . The total number of 0 \& 1 scores are added together and then divided by the total number of sites in the mouth evaluated to give the average number of bleeding sites in the mouth. |
| Primary | Plaque Index (Quigley-Hein Score) | 6 weeks | 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
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Gingival Index | 6 weeks | Units on a scale | MEAN | |
| PRIMARY | EIBI Bleeding Score: Eastman Indterdental Bleeding Index Scale | 6 weeks | bleeding sites | MEAN | |
| PRIMARY | Plaque Index (Quigley-Hein Score) | 6 weeks | Units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Gingival Index | Negative Control Rinse | 1.90 | Standard Deviation 0.19 | Units on a scale | |
| Gingival Index | Iocide Mouthrinse | 1.84 | Standard Deviation 0.23 | Units on a scale | |
| EIBI Bleeding Score: Eastman Indterdental Bleeding Index Scale | Negative Control Rinse | 40.82 | Standard Deviation 16.93 | bleeding sites | |
| EIBI Bleeding Score: Eastman Indterdental Bleeding Index Scale | Iocide Mouthrinse | 34.91 | Standard Deviation 23.83 | bleeding sites | |
| Plaque Index (Quigley-Hein Score) | Negative Control Rinse | 2.47 | Standard Deviation 0.61 | Units on a scale | |
| Plaque Index (Quigley-Hein Score) | Iocide Mouthrinse | 2.11 | Standard Deviation 0.70 | Units on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Negative Control Rinse | 36 | |
| Overall Study | STARTED | Iocide Mouthrinse | 37 | |
| Overall Study | COMPLETED | Negative Control Rinse | 34 | |
| Overall Study | COMPLETED | Iocide Mouthrinse | 33 | |
| Overall Study | NOT COMPLETED | Negative Control Rinse | 2 | |
| Overall Study | NOT COMPLETED | Iocide Mouthrinse | 4 |
Source ClinicalTrials.gov
Adverse events6
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 | discomfort in mouth or body | Social circumstances | Negative Control Rinse | 8 | 34 | 8 |
| other | discomfort in mouth or body | Social circumstances | Iocide Mouthrinse | 0 | 33 | 0 |
| other | Tooth staining | General disorders | Negative Control Rinse | 1 | 34 | 1 |
| other | Tooth staining | General disorders | Iocide Mouthrinse | 7 | 33 | 7 |
| other | slight swelling or inflammation of the gums | General disorders | Negative Control Rinse | 3 | 34 | 3 |
| other | slight swelling or inflammation of the gums | General disorders | Iocide Mouthrinse | 2 | 33 | 2 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Negative Control Rinse | ||
| Total, all-cause mortality | Iocide Mouthrinse | ||
| Total, other adverse events | Negative Control Rinse | 12 | 34 |
| Total, other adverse events | Iocide Mouthrinse | 9 | 33 |
| Total, serious adverse events | Negative Control Rinse | 0 | 34 |
| Total, serious adverse events | Iocide Mouthrinse | 0 | 33 |
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 |
|---|
| Negative Control Rinse vs Iocide Mouthrinse: 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/NCT01021007
GET https://conductscience.org/api/trials/v1/NCT01021007/registered