Trial Outcomes & Findings for Assessing Gingivitis of 3 Different Dentifrices Compared to a Negative Control. (NCT NCT06892834)
NCT ID: NCT06892834
Last Updated: 2026-05-04
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
120 participants
Primary outcome timeframe
4 weeks (~1 month) and 12 weeks (~3 months)
Results posted on
2026-05-04
Participant Flow
Participant milestones
| Measure |
Negative Control
0.76% Sodium Monofluorophosphate
|
Experimental #1
0.243% NaF with 0.1% Hops, Humulus lupulus extract \[0.045% hops β-acids\]
|
Experimental #2
0.243% NaF with 0.5% Hops, Humulus lupulus extract \[0.225% hops β-acids\]
|
Positive Control
0.454% stannous fluoride, 0.533% zinc citrate
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Assessing Gingivitis of 3 Different Dentifrices Compared to a Negative Control.
Baseline characteristics by cohort
| Measure |
Negative Control
n=30 Participants
0.76% Sodium Monofluorophosphate
Sodium monofluorophosphate dentifrice: Each subject will be randomly assigned to one of four treatment products and will be asked to brush 2x a day (1 minute per brushing) for 3 months.
|
Experimental #1
n=30 Participants
0.243% NaF with 0.1% Hops, Humulus lupulus extract \[0.045% hops β-acids\]
Sodium Fluoride Dentifrice: Each subject will be randomly assigned to one of four treatment products and will be asked to brush 2x a day (1 minute per brushing) for 3 months.
|
Experimental #2
n=30 Participants
0.243% NaF with 0.5% Hops, Humulus lupulus extract \[0.225% hops β-acids\]
Sodium Fluoride Dentifrice: Each subject will be randomly assigned to one of four treatment products and will be asked to brush 2x a day (1 minute per brushing) for 3 months.
|
Positive Control
n=30 Participants
0.454% stannous fluoride, 0.533% zinc citrate
Stannous Fluoride Dentifrice: Each subject will be randomly assigned to one of four treatment products and will be asked to brush 2x a day (1 minute per brushing) for 3 months.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
46.00 years
STANDARD_DEVIATION 15.326 • n=54 Participants
|
51.20 years
STANDARD_DEVIATION 14.639 • n=60 Participants
|
48.23 years
STANDARD_DEVIATION 15.664 • n=114 Participants
|
43.63 years
STANDARD_DEVIATION 16.155 • n=1 Participants
|
47.27 years
STANDARD_DEVIATION 15.516 • n=9 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=54 Participants
|
20 Participants
n=60 Participants
|
22 Participants
n=114 Participants
|
20 Participants
n=1 Participants
|
82 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=54 Participants
|
10 Participants
n=60 Participants
|
8 Participants
n=114 Participants
|
10 Participants
n=1 Participants
|
38 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
1 Participants
n=1 Participants
|
4 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=54 Participants
|
29 Participants
n=60 Participants
|
29 Participants
n=114 Participants
|
29 Participants
n=1 Participants
|
116 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=54 Participants
|
6 Participants
n=60 Participants
|
9 Participants
n=114 Participants
|
8 Participants
n=1 Participants
|
27 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=54 Participants
|
5 Participants
n=60 Participants
|
12 Participants
n=114 Participants
|
11 Participants
n=1 Participants
|
41 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=54 Participants
|
18 Participants
n=60 Participants
|
9 Participants
n=114 Participants
|
11 Participants
n=1 Participants
|
51 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=9 Participants
|
|
Region of Enrollment
Canada
|
30 participants
n=54 Participants
|
30 participants
n=60 Participants
|
30 participants
n=114 Participants
|
30 participants
n=1 Participants
|
120 participants
n=9 Participants
|
PRIMARY outcome
Timeframe: 4 weeks (~1 month) and 12 weeks (~3 months)Population: Number of Bleeding sites
Outcome measures
| Measure |
Negative Control
n=30 Participants
0.76% Sodium Monofluorophosphate
Sodium monofluorophosphate dentifrice: Each subject will be randomly assigned to one of four treatment products and will be asked to brush 2x a day (1 minute per brushing) for 3 months.
|
Experimental #1
n=30 Participants
0.243% NaF with 0.1% Hops, Humulus lupulus extract \[0.045% hops β-acids\]
Sodium Fluoride Dentifrice: Each subject will be randomly assigned to one of four treatment products and will be asked to brush 2x a day (1 minute per brushing) for 3 months.
|
Experimental #2
n=30 Participants
0.243% NaF with 0.5% Hops, Humulus lupulus extract \[0.225% hops β-acids\]
Sodium Fluoride Dentifrice: Each subject will be randomly assigned to one of four treatment products and will be asked to brush 2x a day (1 minute per brushing) for 3 months.
|
Positive Control
n=30 Participants
0.454% stannous fluoride, 0.533% zinc citrate
Stannous Fluoride Dentifrice: Each subject will be randomly assigned to one of four treatment products and will be asked to brush 2x a day (1 minute per brushing) for 3 months.
|
|---|---|---|---|---|
|
Number Bleeding Sites
4 weeks (~1 month)
|
31.52 number of bleeding sites
Standard Error 0.471
|
25.90 number of bleeding sites
Standard Error 0.700
|
21.65 number of bleeding sites
Standard Error 0.507
|
19.13 number of bleeding sites
Standard Error 1.017
|
|
Number Bleeding Sites
12 weeks (~3 Months)
|
28.37 number of bleeding sites
Standard Error 0.555
|
20.18 number of bleeding sites
Standard Error 0.700
|
13.92 number of bleeding sites
Standard Error 0.443
|
9.22 number of bleeding sites
Standard Error 0.866
|
SECONDARY outcome
Timeframe: 4 weeks (~1 month) and 12 weeks (~3 months)scored on a scale of 0-3; 0 Normal gingiva; 1 Mild inflammation - slight change in colour, slight edema. No bleeding on probing; 2 Moderate inflammation - redness, edema, and glazing. Bleeding on probing; 3 Severe inflammation - marked redness, edema. Ulceration. Tendency to spontaneous bleeding
Outcome measures
| Measure |
Negative Control
n=30 Participants
0.76% Sodium Monofluorophosphate
Sodium monofluorophosphate dentifrice: Each subject will be randomly assigned to one of four treatment products and will be asked to brush 2x a day (1 minute per brushing) for 3 months.
|
Experimental #1
n=30 Participants
0.243% NaF with 0.1% Hops, Humulus lupulus extract \[0.045% hops β-acids\]
Sodium Fluoride Dentifrice: Each subject will be randomly assigned to one of four treatment products and will be asked to brush 2x a day (1 minute per brushing) for 3 months.
|
Experimental #2
n=30 Participants
0.243% NaF with 0.5% Hops, Humulus lupulus extract \[0.225% hops β-acids\]
Sodium Fluoride Dentifrice: Each subject will be randomly assigned to one of four treatment products and will be asked to brush 2x a day (1 minute per brushing) for 3 months.
|
Positive Control
n=30 Participants
0.454% stannous fluoride, 0.533% zinc citrate
Stannous Fluoride Dentifrice: Each subject will be randomly assigned to one of four treatment products and will be asked to brush 2x a day (1 minute per brushing) for 3 months.
|
|---|---|---|---|---|
|
Löe-Silness Gingivitis Evaluation
1 Month
|
1.18 score on scale
Standard Error 0.006
|
1.11 score on scale
Standard Error 0.005
|
1.07 score on scale
Standard Error 0.006
|
1.06 score on scale
Standard Error 0.009
|
|
Löe-Silness Gingivitis Evaluation
3 Months
|
1.16 score on scale
Standard Error 0.006
|
1.06 score on scale
Standard Error 0.007
|
0.98 score on scale
Standard Error 0.012
|
0.93 score on scale
Standard Error 0.010
|
Adverse Events
Positive Control
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Experimental #1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental #2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Negative Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Positive Control
n=30 participants at risk
0.454% stannous fluoride, 0.533% zinc citrate
Stannous Fluoride Dentifrice: Each subject will be randomly assigned to one of four treatment products and will be asked to brush 2x a day (1 minute per brushing) for 12 weeks (\~3 months).
|
Experimental #1
n=30 participants at risk
0.243% NaF with 0.1% Hops, Humulus lupulus extract \[0.045% hops β-acids\]
Sodium Fluoride Dentifrice: Each subject will be randomly assigned to one of four treatment products and will be asked to brush 2x a day (1 minute per brushing) for 12 weeks (\~3 months).
|
Experimental #2
n=30 participants at risk
0.243% NaF with 0.5% Hops, Humulus lupulus extract \[0.225% hops β-acids\]
Sodium Fluoride Dentifrice: Each subject will be randomly assigned to one of four treatment products and will be asked to brush 2x a day (1 minute per brushing) for 12 weeks (\~3 months).
|
Negative Control
n=30 participants at risk
0.76% Sodium Monofluorophosphate
Sodium monofluorophosphate dentifrice: Each subject will be randomly assigned to one of four treatment products and will be asked to brush 2x a day (1 minute per brushing) for 12 weeks (\~3 months).
|
|---|---|---|---|---|
|
Nervous system disorders
HEADACHE
|
6.7%
2/30 • Number of events 2 • Data collected over 12 weeks (~3 months) of product use.
|
0.00%
0/30 • Data collected over 12 weeks (~3 months) of product use.
|
0.00%
0/30 • Data collected over 12 weeks (~3 months) of product use.
|
0.00%
0/30 • Data collected over 12 weeks (~3 months) of product use.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI agrees not to publish the results of a study without the prior written consent of Sponsor.
- Publication restrictions are in place
Restriction type: OTHER