Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Evaluate the efficacy of an oral rinse on dental plaque and gingival inflammation
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Placebo Comparator | control mouthrinse |
|
| B | Experimental | new prototype mouthrinse |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iodine | Drug | Rinse 2 times per day for 6 weeks |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Gingival Index | 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 | 6 weeks |
| EIBI Bleeding Score: Eastman Indterdental Bleeding Index Scale | 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. | 6 weeks |
| Plaque Index (Quigley-Hein Score) | 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) | 6 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Matthew Cronin, DMD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Institutional Service Company | Northfield | New Jersey | 08225 | United States |
Not provided
At clinical site
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Negative Control Rinse | Placebo mouthrinse |
| FG001 | Iocide Mouthrinse | Experimental mouthrinse |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Negative Control Rinse | Placebo mouthrinse |
| BG001 | Iocide Mouthrinse | Experimental mouthrinse |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Gingival Index | 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 | Posted | Mean | Standard Deviation | Units on a scale | 6 weeks |
|
7 week study period
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Negative Control Rinse | Placebo mouthrinse |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| discomfort in mouth or body | Social circumstances | Non-systematic Assessment | 1 panelist reported discomfort from a popcorn kernel stuck between teeth. 7 panelists reported discomfort in ranging from a tooth ache to muscle pains. All unrelated to study product use and went away with no lingering effects to the panelist. |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William DeVizio - DMD | Colgate Palmolive | 732-878-7901 | william_devizio@colpal.com |
Not provided
| ID | Term |
|---|---|
| D003773 | Dental Plaque |
| ID | Term |
|---|---|
| D003741 | Dental Deposits |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007455 | Iodine |
| D014867 | Water |
| ID | Term |
|---|---|
| D006219 | Halogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D006878 | Hydroxides |
| D000468 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| water | Other | Use 2 times per day for 6 weeks |
|
|
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Primary | EIBI Bleeding Score: Eastman Indterdental Bleeding Index Scale | 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. | Posted | Mean | Standard Deviation | bleeding sites | 6 weeks |
|
|
|
|
| Primary | Plaque Index (Quigley-Hein Score) | 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) | Posted | Mean | Standard Deviation | Units on a scale | 6 weeks |
|
|
|
|
| 0 |
| 34 |
| 12 |
| 34 |
| EG001 | Iocide Mouthrinse | Experimental mouthrinse | 0 | 33 | 9 | 33 |
|
| Tooth staining | General disorders | Non-systematic Assessment | Panelist reports the appearence of yellow to brown staining of their teeth. All staining was removed after a dental cleaning. No lingering effects to the panelist. |
|
| slight swelling or inflammation of the gums | General disorders | Non-systematic Assessment | panelists reported slight iritation or tenderness or swelling or inflammation of the tongue or gums. All chages reported to the panelists oral health were resolved during the study and no lingering effects were noted. |
|
Not provided
| Alkalies |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |