Trial Outcomes & Findings for A Phase 3 Clinical Study Investigating the Gingivitis Efficacy of a Test Dentifrice Containing Stannous Fluoride (NCT NCT04123665)
NCT ID: NCT04123665
Last Updated: 2020-01-31
Results Overview
BI-to assess bleeding elicited on probing as a measure of gingival condition. Gingivae were air dried and examiner assessed bleeding using a probe which was gently inserted into gingival crevice to depth of approximately(app)1millimeter(mm)and run around tooth(angle of app60\[degrees(deg)\] to long axis of tooth), gently stretching epithelium while sweeping from interproximal to interproximal along sulcular epithelium. BI assessed on facial and lingual gingival surfaces of each scorable tooth(7in each arch). 3scores were recorded buccally/labially,3scores lingually/palatally. All scorable teeth in one quadrant were probed first(app30seconds\[sec\])before recording number of gingival units which bled. Values presented as means across all tooth surfaces with minimum and maximum scores in agreement with minimum and maximum index values(i.e.,0-2).BI score:0=no bleeding after30sec,1=bleeding upon probing after30sec,2=immediate bleeding observed. Lower scores indicate better results.
COMPLETED
PHASE3
98 participants
At Week 24
2020-01-31
Participant Flow
Participants were recruited from one center in United States.
A total of 125 participants were screened for the study. Of these, 98 participants were enrolled and allocated to a randomized treatment. 27 participants were not enrolled, of which, 19 did not meet study criteria, 3 lost to follow-up and 5 withdrew their consent.
Participant milestones
| Measure |
Experimental Test Stannous Fluoride Dentifrice
In this arm, participants applied a full ribbon of dentifrice (0.454% weight by weight \[w/w\] stannous fluoride) to the bristles of a study toothbrush and brushed their teeth in their usual manner for one timed minute twice daily (morning and evening) and recorded on their study diary completed brushings for 24 weeks.
|
Control Sodium Monofluorophosphate Dentifrice
In this arm, participants applied a full ribbon of negative control dentifrice (1000 parts per million \[ppm\] fluoride as sodium monofluorophosphate \[SMFP\] to the bristles of a study toothbrush and brushed their teeth in their usual manner for one timed minute twice daily (morning and evening) and recorded on their study diary completed brushings for 24 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
48
|
|
Overall Study
COMPLETED
|
42
|
48
|
|
Overall Study
NOT COMPLETED
|
8
|
0
|
Reasons for withdrawal
| Measure |
Experimental Test Stannous Fluoride Dentifrice
In this arm, participants applied a full ribbon of dentifrice (0.454% weight by weight \[w/w\] stannous fluoride) to the bristles of a study toothbrush and brushed their teeth in their usual manner for one timed minute twice daily (morning and evening) and recorded on their study diary completed brushings for 24 weeks.
|
Control Sodium Monofluorophosphate Dentifrice
In this arm, participants applied a full ribbon of negative control dentifrice (1000 parts per million \[ppm\] fluoride as sodium monofluorophosphate \[SMFP\] to the bristles of a study toothbrush and brushed their teeth in their usual manner for one timed minute twice daily (morning and evening) and recorded on their study diary completed brushings for 24 weeks.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
7
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
A subgroup analysis using MGI stratification based upon gender
Baseline characteristics by cohort
| Measure |
Experimental Test Stannous Fluoride Dentifrice
n=50 Participants
In this arm, participants applied a full ribbon of dentifrice (0.454% weight by weight \[w/w\] stannous fluoride) to the bristles of a study toothbrush and brushed their teeth in their usual manner for one timed minute twice daily (morning and evening) and recorded on their study diary completed brushings for 24 weeks.
|
Control Sodium Monofluorophosphate Dentifrice
n=48 Participants
In this arm, participants applied a full ribbon of negative control dentifrice (1000 parts per million \[ppm\] fluoride as sodium monofluorophosphate \[SMFP\] to the bristles of a study toothbrush and brushed their teeth in their usual manner for one timed minute twice daily (morning and evening) and recorded on their study diary completed brushings for 24 weeks.
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.5 Years
STANDARD_DEVIATION 14.55 • n=50 Participants
|
38.8 Years
STANDARD_DEVIATION 12.44 • n=48 Participants
|
39.2 Years
STANDARD_DEVIATION 13.49 • n=98 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=50 Participants
|
31 Participants
n=48 Participants
|
65 Participants
n=98 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=50 Participants
|
17 Participants
n=48 Participants
|
33 Participants
n=98 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=50 Participants
|
0 Participants
n=48 Participants
|
1 Participants
n=98 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=50 Participants
|
1 Participants
n=48 Participants
|
1 Participants
n=98 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=50 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=98 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=50 Participants
|
8 Participants
n=48 Participants
|
12 Participants
n=98 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=50 Participants
|
39 Participants
n=48 Participants
|
82 Participants
n=98 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=50 Participants
|
0 Participants
n=48 Participants
|
2 Participants
n=98 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=50 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=98 Participants
|
|
Baseline Modified Gingival Index (MGI) strata
Male · MGI less than or equal to [<=] 2.00
|
5 Participants
n=16 Participants • A subgroup analysis using MGI stratification based upon gender
|
5 Participants
n=17 Participants • A subgroup analysis using MGI stratification based upon gender
|
10 Participants
n=33 Participants • A subgroup analysis using MGI stratification based upon gender
|
|
Baseline Modified Gingival Index (MGI) strata
Male · MGI more than [>] 2.00
|
11 Participants
n=16 Participants • A subgroup analysis using MGI stratification based upon gender
|
12 Participants
n=17 Participants • A subgroup analysis using MGI stratification based upon gender
|
23 Participants
n=33 Participants • A subgroup analysis using MGI stratification based upon gender
|
|
Baseline Modified Gingival Index (MGI) strata
Female · MGI less than or equal to [<=] 2.00
|
18 Participants
n=34 Participants • A subgroup analysis using MGI stratification based upon gender
|
16 Participants
n=31 Participants • A subgroup analysis using MGI stratification based upon gender
|
34 Participants
n=65 Participants • A subgroup analysis using MGI stratification based upon gender
|
|
Baseline Modified Gingival Index (MGI) strata
Female · MGI more than [>] 2.00
|
16 Participants
n=34 Participants • A subgroup analysis using MGI stratification based upon gender
|
15 Participants
n=31 Participants • A subgroup analysis using MGI stratification based upon gender
|
31 Participants
n=65 Participants • A subgroup analysis using MGI stratification based upon gender
|
PRIMARY outcome
Timeframe: At Week 24Population: Intent-to-treat (ITT) population \[N=91\] included all participants who received study treatment and had at least one post-baseline efficacy measurement. Number analyzed in this outcome measure signifies those who were evaluated.
BI-to assess bleeding elicited on probing as a measure of gingival condition. Gingivae were air dried and examiner assessed bleeding using a probe which was gently inserted into gingival crevice to depth of approximately(app)1millimeter(mm)and run around tooth(angle of app60\[degrees(deg)\] to long axis of tooth), gently stretching epithelium while sweeping from interproximal to interproximal along sulcular epithelium. BI assessed on facial and lingual gingival surfaces of each scorable tooth(7in each arch). 3scores were recorded buccally/labially,3scores lingually/palatally. All scorable teeth in one quadrant were probed first(app30seconds\[sec\])before recording number of gingival units which bled. Values presented as means across all tooth surfaces with minimum and maximum scores in agreement with minimum and maximum index values(i.e.,0-2).BI score:0=no bleeding after30sec,1=bleeding upon probing after30sec,2=immediate bleeding observed. Lower scores indicate better results.
Outcome measures
| Measure |
Experimental Test Stannous Fluoride Dentifrice
n=43 Participants
In this arm, participants applied a full ribbon of dentifrice (0.454% weight by weight \[w/w\] stannous fluoride) to the bristles of a study toothbrush and brushed their teeth in their usual manner for one timed minute twice daily (morning and evening) and recorded on their study diary completed brushings for 24 weeks.
|
Control Sodium Monofluorophosphate Dentifrice
n=48 Participants
In this arm, participants applied a full ribbon of negative control dentifrice (1000 parts per million \[ppm\] fluoride as sodium monofluorophosphate \[SMFP\] to the bristles of a study toothbrush and brushed their teeth in their usual manner for one timed minute twice daily (morning and evening) and recorded on their study diary completed brushings for 24 weeks.
|
|---|---|---|
|
Evaluation and Comparison of Gingival Health Measured by Bleeding Index (BI) at 24 Weeks
|
0.11 Score on scale
Standard Deviation 0.094
|
0.19 Score on scale
Standard Deviation 0.105
|
SECONDARY outcome
Timeframe: At Week 12Population: ITT population \[N=91\] included all participants who were enrolled and randomly allocated to treatment and are analyzed in the groups to which they were randomized.
BI-to assess bleeding elicited on probing as a measure of gingival condition. Gingivae were air dried and examiner assessed bleeding using a probe which was gently inserted into gingival crevice to depth of app 1 mm and run around tooth (angle of app 60 deg to long axis of tooth), gently stretching epithelium while sweeping from interproximal to interproximal along sulcular epithelium. BI assessed on facial and lingual gingival surfaces of each scorable tooth (7in each arch). 3 scores were recorded buccally/ labially, 3scores lingually/ palatally. All scorable teeth in one quadrant were probed first (app 30 sec) before recording number of gingival units which bled. Values presented as means across all tooth surfaces with minimum and maximum scores in agreement with minimum and maximum index values (i.e.,0-2). BI score:0=no bleeding after 30 sec, 1=bleeding upon probing after 30 sec,2=immediate bleeding observed. Lower scores indicate better results.
Outcome measures
| Measure |
Experimental Test Stannous Fluoride Dentifrice
n=43 Participants
In this arm, participants applied a full ribbon of dentifrice (0.454% weight by weight \[w/w\] stannous fluoride) to the bristles of a study toothbrush and brushed their teeth in their usual manner for one timed minute twice daily (morning and evening) and recorded on their study diary completed brushings for 24 weeks.
|
Control Sodium Monofluorophosphate Dentifrice
n=48 Participants
In this arm, participants applied a full ribbon of negative control dentifrice (1000 parts per million \[ppm\] fluoride as sodium monofluorophosphate \[SMFP\] to the bristles of a study toothbrush and brushed their teeth in their usual manner for one timed minute twice daily (morning and evening) and recorded on their study diary completed brushings for 24 weeks.
|
|---|---|---|
|
Evaluation and Comparison of Gingival Health Measured by BI at 12 Weeks
|
0.11 Score on scale
Standard Deviation 0.104
|
0.23 Score on scale
Standard Deviation 0.124
|
SECONDARY outcome
Timeframe: At Week 12 and Week 24Population: Analysis was performed on a subgroup of ITT population (included all participants who received study treatment and had at least one post-baseline efficacy measurement) that included participants with MGI \<=2.00 \[N=39\] . Number analyzed included participants with available data for each specified category.
BI-to assess bleeding elicited on probing as measure of gingival condition.Gingivae were air dried,examiner assessed bleeding using probe gently inserted into gingival crevice to depth of app.1mm and run around tooth(at angle of app.60deg to long axis of tooth),gently stretching epithelium while sweeping from interproximal to interproximal along sulcular epithelium.BI assessed on facial,lingual gingival surfaces of each scorable tooth(7in each arch).3scores recorded buccally/labially and 3lingually/palatally. All scorable teeth in 1quadrant probed first(app.30sec)before recording number of gingival units which bled.Participants stratified based upon gender and baseline MGI score(Low:\<=2.00,High: \>2.00).Whole mouth mean of BI calculated by-taking average overall tooth sites assessed;to compare magnitude of differences in two strata.BI scoring:0=no bleeding after 30sec,1=bleeding upon probing after 30sec,2=immediate bleeding observed. Lower scores- better results.
Outcome measures
| Measure |
Experimental Test Stannous Fluoride Dentifrice
n=18 Participants
In this arm, participants applied a full ribbon of dentifrice (0.454% weight by weight \[w/w\] stannous fluoride) to the bristles of a study toothbrush and brushed their teeth in their usual manner for one timed minute twice daily (morning and evening) and recorded on their study diary completed brushings for 24 weeks.
|
Control Sodium Monofluorophosphate Dentifrice
n=21 Participants
In this arm, participants applied a full ribbon of negative control dentifrice (1000 parts per million \[ppm\] fluoride as sodium monofluorophosphate \[SMFP\] to the bristles of a study toothbrush and brushed their teeth in their usual manner for one timed minute twice daily (morning and evening) and recorded on their study diary completed brushings for 24 weeks.
|
|---|---|---|
|
Evaluation and Comparison of Gingival Health Measured by BI Indices in Low MGI Subgroups (<=2.00) After 12 and 24 Weeks
At week 12 with baseline MGI <=2.00
|
0.11 Score on scale
Standard Deviation 0.119
|
0.21 Score on scale
Standard Deviation 0.093
|
|
Evaluation and Comparison of Gingival Health Measured by BI Indices in Low MGI Subgroups (<=2.00) After 12 and 24 Weeks
At week 24 with baseline MGI <=2.00
|
0.10 Score on scale
Standard Deviation 0.097
|
0.16 Score on scale
Standard Deviation 0.082
|
SECONDARY outcome
Timeframe: At Week 12 and Week 24Population: Analysis was performed on a subgroup of ITT population (included all participants who received study treatment and had at least one post-baseline efficacy measurement) that included participants with MGI \>2.00 \[N=52\] . Number analyzed included participants with available data for each specified category.
BI-to assess bleeding elicited on probing as measure of gingival condition.Gingivae were air dried,examiner assessed bleeding using probe gently inserted into gingival crevice to depth of app.1mm and run around tooth(at angle of app.60deg to long axis of tooth),gently stretching epithelium while sweeping from interproximal to interproximal along sulcular epithelium.BI assessed on facial,lingual gingival surfaces of each scorable tooth(7in each arch).3scores recorded buccally/labially and 3lingually/palatally. All scorable teeth in 1quadrant probed first(app.30sec)before recording number of gingival units which bled.Participants stratified based upon gender and baseline MGI score(Low:\<=2.00,High: \>2.00).Whole mouth mean of BI calculated by-taking average overall tooth sites assessed;to compare magnitude of differences in two strata.BI scoring:0=no bleeding after 30sec,1=bleeding upon probing after 30sec,2=immediate bleeding observed. Lower scores- better results.
Outcome measures
| Measure |
Experimental Test Stannous Fluoride Dentifrice
n=25 Participants
In this arm, participants applied a full ribbon of dentifrice (0.454% weight by weight \[w/w\] stannous fluoride) to the bristles of a study toothbrush and brushed their teeth in their usual manner for one timed minute twice daily (morning and evening) and recorded on their study diary completed brushings for 24 weeks.
|
Control Sodium Monofluorophosphate Dentifrice
n=27 Participants
In this arm, participants applied a full ribbon of negative control dentifrice (1000 parts per million \[ppm\] fluoride as sodium monofluorophosphate \[SMFP\] to the bristles of a study toothbrush and brushed their teeth in their usual manner for one timed minute twice daily (morning and evening) and recorded on their study diary completed brushings for 24 weeks.
|
|---|---|---|
|
Evaluation and Comparison of Gingival Health Measured by BI Indices in High MGI Subgroup (>2.00) at 12 and 24 Weeks
At week 12 with baseline MGI >2.00
|
0.11 Score on scale
Standard Deviation 0.094
|
0.25 Score on scale
Standard Deviation 0.144
|
|
Evaluation and Comparison of Gingival Health Measured by BI Indices in High MGI Subgroup (>2.00) at 12 and 24 Weeks
At week 24 with baseline MGI >2.00
|
0.12 Score on scale
Standard Deviation 0.092
|
0.21 Score on scale
Standard Deviation 0.117
|
SECONDARY outcome
Timeframe: At Week 12 and Week 24Population: Analysis was performed on ITT population \[N=91\] which included all participants who received study treatment and had at least one post-baseline efficacy measurement. Number analyzed included participants with available data for each specified category.
MGI- to assess visual symptoms of gingivitis on facial and lingual surfaces of each scorable tooth (7 in each arch). 2scores recorded buccally/labially, 2scores lingually/palatally. Values presented as means across all tooth surfaces with minimum and maximum scores in agreement with minimum and maximum index values (i.e.,0-4). Scoring was performed using standard dental light:0=absence of inflammation,1=mild inflammation;slight change in color,little change in color; little change in texture of any portion of the marginal or papillary gingival unit,2=mild inflammation; criteria as above plus the entire marginal or papillar gingival unit,3=moderate inflammation;glazing, redness, edema, and/or hypertrophy of the marginal or papillary gingival unit,4=severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit,spontaneous bleeding,congestion,or ulceration. Lower scores indicate better results.
Outcome measures
| Measure |
Experimental Test Stannous Fluoride Dentifrice
n=43 Participants
In this arm, participants applied a full ribbon of dentifrice (0.454% weight by weight \[w/w\] stannous fluoride) to the bristles of a study toothbrush and brushed their teeth in their usual manner for one timed minute twice daily (morning and evening) and recorded on their study diary completed brushings for 24 weeks.
|
Control Sodium Monofluorophosphate Dentifrice
n=48 Participants
In this arm, participants applied a full ribbon of negative control dentifrice (1000 parts per million \[ppm\] fluoride as sodium monofluorophosphate \[SMFP\] to the bristles of a study toothbrush and brushed their teeth in their usual manner for one timed minute twice daily (morning and evening) and recorded on their study diary completed brushings for 24 weeks.
|
|---|---|---|
|
Evaluation and Comparison of Gingival Health Measured by Modified Gingival Index (MGI) at 12 and 24 Weeks
At week 12
|
1.43 Score on scale
Standard Deviation 0.403
|
1.87 Score on scale
Standard Deviation 0.237
|
|
Evaluation and Comparison of Gingival Health Measured by Modified Gingival Index (MGI) at 12 and 24 Weeks
At week 24
|
1.46 Score on scale
Standard Deviation 0.373
|
1.78 Score on scale
Standard Deviation 0.316
|
SECONDARY outcome
Timeframe: At Week 12 and Week 24Population: Analysis was performed on a subgroup of ITT population (included all participants who received study treatment and had at least one post-baseline efficacy measurement) that included participants with MGI \<=2.00 \[N=39\] . Number analyzed included participants with available data for each specified category.
MGI-to assess gingivitis symptoms on facial, lingual surfaces of each scorable tooth(7in each arch).2 scores recorded buccally/labially(papilla,margin),2lingually/palatally(papilla,margin).Participants stratified based upon gender and baseline MGI score(Low:\<=2.00,High:\>2.00).Whole mouth mean of MGI calculated by-taking average overall tooth sites assessed;to compare magnitude of differences in two strata.MGI scoring:0=absence of inflammation, 1=mild inflammation;slight change in color,little change in color;little change in texture of any portion of the marginal or papillary gingival unit,2=mild inflammation;criteria as above plus the entire marginal or papillar gingival unit,3=moderate inflammation;glazing,redness,edema,and/or hypertrophy of the marginal or papillary gingival unit,4=severe inflammation;marked redness,edema and/or hypertrophy of the marginal or papillary gingival unit,spontaneous bleeding,congestion or ulceration. Lower scores indicate better results.
Outcome measures
| Measure |
Experimental Test Stannous Fluoride Dentifrice
n=18 Participants
In this arm, participants applied a full ribbon of dentifrice (0.454% weight by weight \[w/w\] stannous fluoride) to the bristles of a study toothbrush and brushed their teeth in their usual manner for one timed minute twice daily (morning and evening) and recorded on their study diary completed brushings for 24 weeks.
|
Control Sodium Monofluorophosphate Dentifrice
n=21 Participants
In this arm, participants applied a full ribbon of negative control dentifrice (1000 parts per million \[ppm\] fluoride as sodium monofluorophosphate \[SMFP\] to the bristles of a study toothbrush and brushed their teeth in their usual manner for one timed minute twice daily (morning and evening) and recorded on their study diary completed brushings for 24 weeks.
|
|---|---|---|
|
Evaluation and Comparison of Gingival Health Measured by MGI Indices in Low MGI Subgroup (<=2.00) at 12 and 24 Weeks
At week 12 with baseline MGI <=2.00
|
1.26 Score on scale
Standard Deviation 0.409
|
1.74 Score on scale
Standard Deviation 0.199
|
|
Evaluation and Comparison of Gingival Health Measured by MGI Indices in Low MGI Subgroup (<=2.00) at 12 and 24 Weeks
At week 24 with baseline MGI <=2.00
|
1.29 Score on scale
Standard Deviation 0.383
|
1.60 Score on scale
Standard Deviation 0.319
|
SECONDARY outcome
Timeframe: At Week 12 and Week 24Population: Analysis was performed on a subgroup of ITT population (included all participants who received study treatment and had at least one post-baseline efficacy measurement) that included participants with MGI \>2.00 \[N=52\] . Number analyzed included participants with available data for each specified category.
MGI-to assess gingivitis symptoms on facial, lingual surfaces of each scorable tooth(7in each arch).2 scores recorded buccally/labially(papilla,margin),2lingually/palatally(papilla,margin).Participants stratified based upon gender and baseline MGI score(Low:\<=2.00,High:\>2.00).Whole mouth mean of MGI calculated by-taking average overall tooth sites assessed;to compare magnitude of differences in two strata.MGI scoring:0=absence of inflammation, 1=mild inflammation;slight change in color,little change in color;little change in texture of any portion of the marginal or papillary gingival unit,2=mild inflammation;criteria as above plus the entire marginal or papillar gingival unit,3=moderate inflammation;glazing,redness,edema,and/or hypertrophy of the marginal or papillary gingival unit,4=severe inflammation;marked redness,edema and/or hypertrophy of the marginal or papillary gingival unit,spontaneous bleeding,congestion or ulceration. Lower scores indicate better results.
Outcome measures
| Measure |
Experimental Test Stannous Fluoride Dentifrice
n=25 Participants
In this arm, participants applied a full ribbon of dentifrice (0.454% weight by weight \[w/w\] stannous fluoride) to the bristles of a study toothbrush and brushed their teeth in their usual manner for one timed minute twice daily (morning and evening) and recorded on their study diary completed brushings for 24 weeks.
|
Control Sodium Monofluorophosphate Dentifrice
n=27 Participants
In this arm, participants applied a full ribbon of negative control dentifrice (1000 parts per million \[ppm\] fluoride as sodium monofluorophosphate \[SMFP\] to the bristles of a study toothbrush and brushed their teeth in their usual manner for one timed minute twice daily (morning and evening) and recorded on their study diary completed brushings for 24 weeks.
|
|---|---|---|
|
Evaluation and Comparison of Gingival Health Measured by MGI Indices in High MGI Subgroup (>2.00) at 12 and 24 Weeks
At week 12 with baseline MGI >2.00
|
1.54 Score on scale
Standard Deviation 0.364
|
1.96 Score on scale
Standard Deviation 0.220
|
|
Evaluation and Comparison of Gingival Health Measured by MGI Indices in High MGI Subgroup (>2.00) at 12 and 24 Weeks
At week 24 with baseline MGI >2.00
|
1.57 Score on scale
Standard Deviation 0.324
|
1.93 Score on scale
Standard Deviation 0.231
|
SECONDARY outcome
Timeframe: At Week 12 and Week 24Population: Analysis was performed on ITT population \[N=91\] which included all participants who received study treatment and had at least one post-baseline efficacy measurement. Number analyzed included participants with available data for each specified category.
Turesky Modification of Quigley Hein Plaque Index-to assess plaque on all gradable teeth. Participants rinsed the plaque in dye solution of 5milliliters(mL)of solution for 10 sec, then expectorated and rinsed with 10 mL of water for 10 sec and then expectorated again. Plaque was assessed with each tooth being divided into 6 areas including mesiofacial, facial, distofacial, mesiolingual, lingual and distolingual surfaces. Values presented as means across all tooth surfaces with minimum and maximum scores in agreement with minimum and maximum index values (i.e.,0-5). Disclosed plaque scored as:0=no plaque, 1=slight flecks of plaque at the cervical margin of the tooth,2=a thin continuous band of plaque (1mm or smaller) at the cervical margin of the tooth, 3=a band of plaque wider than 1mm but covering less than 1/3 of the area, 4=plaque covering at least 1/3 but less than 2/3 of the area,5=plaque covering 2/3 or more of the crown of the tooth. Lower scores indicate better results.
Outcome measures
| Measure |
Experimental Test Stannous Fluoride Dentifrice
n=43 Participants
In this arm, participants applied a full ribbon of dentifrice (0.454% weight by weight \[w/w\] stannous fluoride) to the bristles of a study toothbrush and brushed their teeth in their usual manner for one timed minute twice daily (morning and evening) and recorded on their study diary completed brushings for 24 weeks.
|
Control Sodium Monofluorophosphate Dentifrice
n=48 Participants
In this arm, participants applied a full ribbon of negative control dentifrice (1000 parts per million \[ppm\] fluoride as sodium monofluorophosphate \[SMFP\] to the bristles of a study toothbrush and brushed their teeth in their usual manner for one timed minute twice daily (morning and evening) and recorded on their study diary completed brushings for 24 weeks.
|
|---|---|---|
|
Evaluation and Comparison of Supra-gingival Plaque Levels Measured by Overall and Inter-proximal Plaque Index (PI) at 12 and 24 Weeks
Overall analysis at week 12
|
2.60 Score on scale
Standard Deviation 0.454
|
2.90 Score on scale
Standard Deviation 0.407
|
|
Evaluation and Comparison of Supra-gingival Plaque Levels Measured by Overall and Inter-proximal Plaque Index (PI) at 12 and 24 Weeks
Overall analysis at week 24
|
2.56 Score on scale
Standard Deviation 0.527
|
2.83 Score on scale
Standard Deviation 0.355
|
|
Evaluation and Comparison of Supra-gingival Plaque Levels Measured by Overall and Inter-proximal Plaque Index (PI) at 12 and 24 Weeks
Interproximal analysis at week 12
|
2.82 Score on scale
Standard Deviation 0.399
|
3.05 Score on scale
Standard Deviation 0.354
|
|
Evaluation and Comparison of Supra-gingival Plaque Levels Measured by Overall and Inter-proximal Plaque Index (PI) at 12 and 24 Weeks
Interproximal analysis at week 24
|
2.78 Score on scale
Standard Deviation 0.469
|
3.00 Score on scale
Standard Deviation 0.317
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At Week 12 and Week 24Population: Analysis was performed on ITT population \[N=91\] which included all participants who received study treatment and had at least one post-baseline efficacy measurement. Number analyzed included participants with available data for each specified category.
Number of gingival bleeding sites were measured as part of bleeding index via a single examiner using a color-coded periodontal probe. The probe was engaged approximately 1 mm into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. For each participant, the scoring system used to measure bleeding sites is as follows: 0= no bleeding after 30 sec, 1= bleeding upon probing after 30 sec, 2= immediate bleeding observed. Lower bleeding sites indicate better results.
Outcome measures
| Measure |
Experimental Test Stannous Fluoride Dentifrice
n=43 Participants
In this arm, participants applied a full ribbon of dentifrice (0.454% weight by weight \[w/w\] stannous fluoride) to the bristles of a study toothbrush and brushed their teeth in their usual manner for one timed minute twice daily (morning and evening) and recorded on their study diary completed brushings for 24 weeks.
|
Control Sodium Monofluorophosphate Dentifrice
n=48 Participants
In this arm, participants applied a full ribbon of negative control dentifrice (1000 parts per million \[ppm\] fluoride as sodium monofluorophosphate \[SMFP\] to the bristles of a study toothbrush and brushed their teeth in their usual manner for one timed minute twice daily (morning and evening) and recorded on their study diary completed brushings for 24 weeks.
|
|---|---|---|
|
Number of Bleeding Sites After 12 and 24 Weeks
At week 12
|
12.26 Number of bleeding sites
Standard Deviation 10.468
|
23.92 Number of bleeding sites
Standard Deviation 11.024
|
|
Number of Bleeding Sites After 12 and 24 Weeks
At week 24
|
12.69 Number of bleeding sites
Standard Deviation 10.120
|
20.19 Number of bleeding sites
Standard Deviation 9.225
|
Adverse Events
Experimental Test Stannous Fluoride Dentifrice
Control Sodium Monofluorophosphate Dentifrice
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Experimental Test Stannous Fluoride Dentifrice
n=50 participants at risk
In this arm, participants applied a full ribbon of dentifrice (0.454% weight by weight \[w/w\] stannous fluoride) to the bristles of a study toothbrush and brushed their teeth in their usual manner for one timed minute twice daily (morning and evening) and recorded on their study diary completed brushings for 24 weeks.
|
Control Sodium Monofluorophosphate Dentifrice
n=48 participants at risk
In this arm, participants applied a full ribbon of negative control dentifrice (1000 parts per million \[ppm\] fluoride as sodium monofluorophosphate \[SMFP\] to the bristles of a study toothbrush and brushed their teeth in their usual manner for one timed minute twice daily (morning and evening) and recorded on their study diary completed brushings for 24 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Mouth Ulceration
|
0.00%
0/50 • From baseline up to week 24
The Safety Population (N=98) included all participants who received at least 1 dose of the study product (test or reference product). Adverse Events (AEs) were regarded as treatment-emergent if they occurred on or after the first study product administration.
|
2.1%
1/48 • Number of events 1 • From baseline up to week 24
The Safety Population (N=98) included all participants who received at least 1 dose of the study product (test or reference product). Adverse Events (AEs) were regarded as treatment-emergent if they occurred on or after the first study product administration.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER