Trial Outcomes & Findings for Potential of Stannous Fluoride Toothpaste to Reduce Gum Disease (NCT NCT02750943)
NCT ID: NCT02750943
Last Updated: 2017-10-26
Results Overview
Number of bleeding sites was measured as bleeding index (BI) via a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI was assessed on the facial and lingual gingival surfaces of each scorable tooth (7-7 in each arch). The BI scoring system used to measure bleeding sites is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed. Bleeding sites were assessed as the number of bleeding sites with a BI score of 1 or 2.
COMPLETED
NA
253 participants
Week 12
2017-10-26
Participant Flow
Participants were recruited in a single center in Germany.
A total of 317 participants were screened. Out of which only 253 participants were randomized.
Participant milestones
| Measure |
Stannous Fluoride
Participants were instructed to apply a full ribbon of dentifrice containing 0.454% weight by weight (w/w) stannous fluoride to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
|
Sodium Monofluorophosphate
Participants were instructed to apply a full ribbon of dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
125
|
128
|
|
Overall Study
COMPLETED
|
119
|
119
|
|
Overall Study
NOT COMPLETED
|
6
|
9
|
Reasons for withdrawal
| Measure |
Stannous Fluoride
Participants were instructed to apply a full ribbon of dentifrice containing 0.454% weight by weight (w/w) stannous fluoride to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
|
Sodium Monofluorophosphate
Participants were instructed to apply a full ribbon of dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
5
|
7
|
Baseline Characteristics
Potential of Stannous Fluoride Toothpaste to Reduce Gum Disease
Baseline characteristics by cohort
| Measure |
Stannous Fluoride
n=125 Participants
Participants were instructed to apply a full ribbon of dentifrice containing 0.454% w/w stannous fluoride to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
|
Sodium Monofluorophosphate
n=128 Participants
Participants were instructed to apply a full ribbon of dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
|
Total
n=253 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.39 Years
STANDARD_DEVIATION 13.610 • n=5 Participants
|
36.37 Years
STANDARD_DEVIATION 13.179 • n=7 Participants
|
37.86 Years
STANDARD_DEVIATION 13.453 • n=5 Participants
|
|
Sex: Female, Male
Female
|
71 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: Intent to treat (ITT) population which included all participants who were randomized, received at least one dose of study product and had at least one post-baseline efficacy measurement. Number of participants analyzed is the number of participants from ITT population evaluated for this outcome at Week 12 for respective treatment arm.
Number of bleeding sites was measured as bleeding index (BI) via a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI was assessed on the facial and lingual gingival surfaces of each scorable tooth (7-7 in each arch). The BI scoring system used to measure bleeding sites is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed. Bleeding sites were assessed as the number of bleeding sites with a BI score of 1 or 2.
Outcome measures
| Measure |
Stannous Fluoride
n=119 Participants
Participants were instructed to apply a full ribbon of dentifrice containing 0.454% w/w stannous fluoride to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
|
Sodium Monofluorophosphate
n=119 Participants
Participants were instructed to apply a full ribbon of dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
|
|---|---|---|
|
Number of Bleeding Sites at Week 12
|
42.02 number of bleeding sites
Standard Error 1.91
|
67.36 number of bleeding sites
Standard Error 1.91
|
SECONDARY outcome
Timeframe: Week 4Population: Intent to treat (ITT) population which included all participants who were randomized, received at least one dose of study product and had at least one post-baseline efficacy measurement. Number of participants analyzed is the number of participants from ITT population evaluated for this outcome at Week 4 for respective treatment arm.
Number of bleeding sites was measured as BI 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. The BI was assessed on the facial and lingual gingival surfaces of each scorable tooth (7-7 in each arch). The BI scoring system used to measure bleeding sites is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed. Bleeding sites were assessed as the number of bleeding sites with a BI score of 1 or 2.
Outcome measures
| Measure |
Stannous Fluoride
n=121 Participants
Participants were instructed to apply a full ribbon of dentifrice containing 0.454% w/w stannous fluoride to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
|
Sodium Monofluorophosphate
n=122 Participants
Participants were instructed to apply a full ribbon of dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
|
|---|---|---|
|
Number of Bleeding Sites at Week 4
|
45.44 number of bleeding sites
Standard Error 1.92
|
68.30 number of bleeding sites
Standard Error 1.91
|
SECONDARY outcome
Timeframe: Week 4, Week 12Population: Intent to treat (ITT) population which included all participants who were randomized, received at least one dose of study product and had at least one post-baseline efficacy measurement. Number of participants analyzed is the number of participants from ITT population evaluated for this outcome at specific time points for respective treatment arm.
BI was assessed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1mm into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system to be used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed
Outcome measures
| Measure |
Stannous Fluoride
n=122 Participants
Participants were instructed to apply a full ribbon of dentifrice containing 0.454% w/w stannous fluoride to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
|
Sodium Monofluorophosphate
n=123 Participants
Participants were instructed to apply a full ribbon of dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
|
|---|---|---|
|
Bleeding Index (BI) at Week 4 and Week 12
BI at Week 4 (n=121, 122)
|
0.29 score on a scale
Standard Error 0.01
|
0.44 score on a scale
Standard Error 0.01
|
|
Bleeding Index (BI) at Week 4 and Week 12
BI at Week 12 (n=119, 119)
|
0.27 score on a scale
Standard Error 0.01
|
0.43 score on a scale
Standard Error 0.01
|
SECONDARY outcome
Timeframe: Week 4, Week 12Population: Intent to treat (ITT) population which included all participants who were randomized, received at least one dose of study product and had at least one post-baseline efficacy measurement. Number of participants analyzed is the number of participants from ITT population evaluated for this outcome at specific time points for respective treatment arm.
MGI was assessed on facial and lingual surfaces at two sites on each tooth (papillae and margin). The scoring of the MGI was performed under dental office conditions using a standard dental light for illuminating the oral cavity. This procedure was performed by a single examiner. The MGI scoring system is as follows: 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 but involving the entire marginal or papillar gingival units; 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.
Outcome measures
| Measure |
Stannous Fluoride
n=122 Participants
Participants were instructed to apply a full ribbon of dentifrice containing 0.454% w/w stannous fluoride to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
|
Sodium Monofluorophosphate
n=123 Participants
Participants were instructed to apply a full ribbon of dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
|
|---|---|---|
|
Modified Gingival Index (MGI) at Week 4 and Week 12
MGI at Week 4
|
2.27 score on a scale
Standard Error 0.01
|
2.40 score on a scale
Standard Error 0.01
|
|
Modified Gingival Index (MGI) at Week 4 and Week 12
MGI at Week 12
|
2.29 score on a scale
Standard Error 0.01
|
2.47 score on a scale
Standard Error 0.01
|
SECONDARY outcome
Timeframe: Week 4, Week 12Population: Intent to treat (ITT) population which included all participants who were randomized, received at least one dose of study product and had at least one post-baseline efficacy measurement. Number of participants analyzed is the number of participants from ITT population evaluated for this outcome at specific time points for respective treatment arm.
Visible blood in expectorate for each participant was classified as (i) Present (Trace or Substantial) (ii) Absent. The number of participants with blood 'Present' (Trace or Substantial) or 'absent' in expectorate was analyzed.
Outcome measures
| Measure |
Stannous Fluoride
n=122 Participants
Participants were instructed to apply a full ribbon of dentifrice containing 0.454% w/w stannous fluoride to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
|
Sodium Monofluorophosphate
n=123 Participants
Participants were instructed to apply a full ribbon of dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
|
|---|---|---|
|
Number of Participants With Visible Blood in Expectorate (Presence [Trace, Substantial]/Absence) at Week4 and Week 12
At Week 4, Visible blood= Present
|
92 number of participants
|
89 number of participants
|
|
Number of Participants With Visible Blood in Expectorate (Presence [Trace, Substantial]/Absence) at Week4 and Week 12
At Week 4, Visible blood= Trace
|
35 number of participants
|
31 number of participants
|
|
Number of Participants With Visible Blood in Expectorate (Presence [Trace, Substantial]/Absence) at Week4 and Week 12
At Week 4, Visible blood= Substantial
|
57 number of participants
|
58 number of participants
|
|
Number of Participants With Visible Blood in Expectorate (Presence [Trace, Substantial]/Absence) at Week4 and Week 12
At Week 4, Visible blood= Absent
|
30 number of participants
|
34 number of participants
|
|
Number of Participants With Visible Blood in Expectorate (Presence [Trace, Substantial]/Absence) at Week4 and Week 12
At Week 12, Visible blood= Present
|
72 number of participants
|
78 number of participants
|
|
Number of Participants With Visible Blood in Expectorate (Presence [Trace, Substantial]/Absence) at Week4 and Week 12
At Week 12, Visible blood= Trace
|
18 number of participants
|
13 number of participants
|
|
Number of Participants With Visible Blood in Expectorate (Presence [Trace, Substantial]/Absence) at Week4 and Week 12
At Week 12, Visible blood= Substantial
|
54 number of participants
|
65 number of participants
|
|
Number of Participants With Visible Blood in Expectorate (Presence [Trace, Substantial]/Absence) at Week4 and Week 12
At Week 12, Visible blood= Absent
|
47 number of participants
|
41 number of participants
|
Adverse Events
Stannous Fluoride
Sodium Monofluorophosphate
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Stannous Fluoride
n=125 participants at risk
Participants were instructed to apply a full ribbon of dentifrice containing 0.454% w/w stannous fluoride to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
|
Sodium Monofluorophosphate
n=128 participants at risk
Participants were instructed to apply a full ribbon of dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Oral hyperkeratosis
|
12.0%
15/125
|
14.8%
19/128
|
|
Gastrointestinal disorders
Gingival pain
|
1.6%
2/125
|
0.00%
0/128
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/125
|
0.78%
1/128
|
|
Injury, poisoning and procedural complications
Face Injury
|
0.00%
0/125
|
0.78%
1/128
|
|
Injury, poisoning and procedural complications
Gingival injury
|
0.80%
1/125
|
0.00%
0/128
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/125
|
0.78%
1/128
|
|
Injury, poisoning and procedural complications
Neck injury
|
0.00%
0/125
|
0.78%
1/128
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/125
|
0.78%
1/128
|
|
Infections and infestations
Nasopharyngitis
|
0.80%
1/125
|
0.00%
0/128
|
|
Infections and infestations
Oral herpes
|
0.80%
1/125
|
0.00%
0/128
|
Additional Information
GSK Response Center
GlaxoSmithKline
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