Trial Outcomes & Findings for To Evaluate the Efficacy and Tolerability of Sodium Bicarbonate Toothpaste (NCT NCT02207907)
NCT ID: NCT02207907
Last Updated: 2017-04-13
Results Overview
Number of gingival bleeding sites were measured as bleeding index 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 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. A bleeding site was considered as a BI score of 1 or 2.
COMPLETED
PHASE2
247 participants
Baseline, 24 weeks
2017-04-13
Participant Flow
The participants were recruited at a clinical site in the USA.
Participant milestones
| Measure |
Sodium Bicarbonate Dentrifice
Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
|
0% Sodium Bicarbonate Dentrifice
Toothpaste containing 1100 ppm fluoride as sodium fluoride
|
|---|---|---|
|
Overall Study
STARTED
|
124
|
123
|
|
Overall Study
COMPLETED
|
113
|
115
|
|
Overall Study
NOT COMPLETED
|
11
|
8
|
Reasons for withdrawal
| Measure |
Sodium Bicarbonate Dentrifice
Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
|
0% Sodium Bicarbonate Dentrifice
Toothpaste containing 1100 ppm fluoride as sodium fluoride
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
6
|
|
Overall Study
Did not meet study criteria
|
3
|
0
|
|
Overall Study
Pregnancy
|
0
|
1
|
Baseline Characteristics
To Evaluate the Efficacy and Tolerability of Sodium Bicarbonate Toothpaste
Baseline characteristics by cohort
| Measure |
Sodium Bicarbonate Dentrifice
n=124 Participants
Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
|
0% Sodium Bicarbonate Dentrifice
n=123 Participants
Toothpaste containing 1100 ppm fluoride as sodium fluoride
|
Total
n=247 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.52 Years
STANDARD_DEVIATION 13.162 • n=99 Participants
|
37.55 Years
STANDARD_DEVIATION 13.977 • n=107 Participants
|
36.03 Years
STANDARD_DEVIATION 13.631 • n=206 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=99 Participants
|
72 Participants
n=107 Participants
|
141 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
106 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, 24 weeksPopulation: Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement.
Number of gingival bleeding sites were measured as bleeding index 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 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. A bleeding site was considered as a BI score of 1 or 2.
Outcome measures
| Measure |
Sodium Bicarbonate Dentrifice
n=118 Participants
Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
|
0% Sodium Bicarbonate Dentrifice
n=122 Participants
Toothpaste containing 1100 ppm fluoride as sodium fluoride
|
|---|---|---|
|
Number of Gingival Bleeding Sites at 24 Weeks
Number of Bleeding Sites at Baseline
|
45.13 number of gingival bleeding sites
Standard Error 1.393
|
45.84 number of gingival bleeding sites
Standard Error 1.448
|
|
Number of Gingival Bleeding Sites at 24 Weeks
Number of Bleeding sites after 24 weeks
|
18.67 number of gingival bleeding sites
Standard Error 1.142
|
36.39 number of gingival bleeding sites
Standard Error 1.510
|
PRIMARY outcome
Timeframe: Baseline, 24 weeksPopulation: Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement
The Modified Gingival Index (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. Compressed air, water and mouth mirrors were available to each examiner. 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 |
Sodium Bicarbonate Dentrifice
n=118 Participants
Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
|
0% Sodium Bicarbonate Dentrifice
n=122 Participants
Toothpaste containing 1100 ppm fluoride as sodium fluoride
|
|---|---|---|
|
Modified Gingival Index (MGI) at 24 Weeks
Modified Gingival Index at Baseline
|
2.53 Units on a scale
Standard Error 0.017
|
2.54 Units on a scale
Standard Error 0.018
|
|
Modified Gingival Index (MGI) at 24 Weeks
Modified Gingival Index after 24 weeks
|
2.23 Units on a scale
Standard Error 0.021
|
2.43 Units on a scale
Standard Error 0.210
|
SECONDARY outcome
Timeframe: Baseline, 6 and 12 weeksPopulation: Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement
Number of gingival bleeding sites were measured as bleeding index 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 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. A bleeding site was considered as a BI score of 1 or 2.
Outcome measures
| Measure |
Sodium Bicarbonate Dentrifice
n=118 Participants
Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
|
0% Sodium Bicarbonate Dentrifice
n=122 Participants
Toothpaste containing 1100 ppm fluoride as sodium fluoride
|
|---|---|---|
|
Number of Gingival Bleeding Sites at 6 and 12 Weeks.
Number of Bleeding Sites after 6 weeks
|
25.40 number of gingival bleeding sites
Standard Error 0.999
|
40.27 number of gingival bleeding sites
Standard Error 1.448
|
|
Number of Gingival Bleeding Sites at 6 and 12 Weeks.
Number of Bleeding sites after 12 weeks
|
20.83 number of gingival bleeding sites
Standard Error 0.915
|
34.23 number of gingival bleeding sites
Standard Error 1.260
|
|
Number of Gingival Bleeding Sites at 6 and 12 Weeks.
Number of Bleeding Sites at Baseline
|
45.13 number of gingival bleeding sites
Standard Error 1.393
|
45.84 number of gingival bleeding sites
Standard Error 1.448
|
SECONDARY outcome
Timeframe: Baseline, 6 and 12 weeksPopulation: Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement
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. Compressed air, water and mouth mirrors were available to each examiner. 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 |
Sodium Bicarbonate Dentrifice
n=118 Participants
Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
|
0% Sodium Bicarbonate Dentrifice
n=122 Participants
Toothpaste containing 1100 ppm fluoride as sodium fluoride
|
|---|---|---|
|
Modified Gingival Index (MGI) at 6 and 12 Weeks.
Modified Gingival Index at Baseline
|
2.53 Units on a scale
Standard Error 0.017
|
2.54 Units on a scale
Standard Error 0.018
|
|
Modified Gingival Index (MGI) at 6 and 12 Weeks.
Modified Gingival Index after 6 weeks
|
2.28 Units on a scale
Standard Error 0.017
|
2.45 Units on a scale
Standard Error 0.018
|
|
Modified Gingival Index (MGI) at 6 and 12 Weeks.
Modified Gingival Index after 12 weeks
|
2.24 Units on a scale
Standard Error 0.018
|
2.40 Units on a scale
Standard Error 0.018
|
SECONDARY outcome
Timeframe: Baseline, 6, 12 and 24 weeksPopulation: Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement
The Bleeding Index was performed by 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 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 |
Sodium Bicarbonate Dentrifice
n=118 Participants
Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
|
0% Sodium Bicarbonate Dentrifice
n=122 Participants
Toothpaste containing 1100 ppm fluoride as sodium fluoride
|
|---|---|---|
|
Bleeding Index at 6, 12 and 24 Weeks
Bleeding Index Score at Baseline
|
0.45 Units on a Scale
Standard Error 0.014
|
0.47 Units on a Scale
Standard Error 0.014
|
|
Bleeding Index at 6, 12 and 24 Weeks
Bleeding Index Score after 6 weeks
|
0.25 Units on a Scale
Standard Error 0.010
|
0.41 Units on a Scale
Standard Error 0.014
|
|
Bleeding Index at 6, 12 and 24 Weeks
Bleeding Index Score after 12 weeks
|
0.21 Units on a Scale
Standard Error 0.009
|
0.35 Units on a Scale
Standard Error 0.012
|
|
Bleeding Index at 6, 12 and 24 Weeks
Bleeding Index Score after 24 weeks
|
0.19 Units on a Scale
Standard Error 0.012
|
0.37 Units on a Scale
Standard Error 0.014
|
SECONDARY outcome
Timeframe: Baseline, 6,12 and 24 weeksPopulation: Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement
The dental examiner used the Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth. The plaque was first disclosed using a dye solution. Participants then rinsed with disclosing solution according to instructions. They had expectorated and rinsed with 10 mL of water for 10 seconds and expectorated again. Plaque was assessed with each tooth being divided into 6 areas including the mesiofacial, facial, distofacial, mesiolingual, lingual and distolingual surfaces. Disclosed plaque was scored as follows: 0= No plaque; 1= Slight flecks of plaque at the cervical margin of the tooth; 2= A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth; 3= A band of plaque wider than 1 mm but covering less than 1/3 of the crown of the tooth; 4= Plaque covering at least 1/3 but less tan 2/3 of the crown of the tooth; 5= Plaque covering 2/3 or more of the crown of the tooth
Outcome measures
| Measure |
Sodium Bicarbonate Dentrifice
n=118 Participants
Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
|
0% Sodium Bicarbonate Dentrifice
n=122 Participants
Toothpaste containing 1100 ppm fluoride as sodium fluoride
|
|---|---|---|
|
Plaque Control (Overall and Interproximal Dental Plaque Scores) Using Turesky Modification of Quigley &Amp; Hein Plaque Index at 6, 12 and 24 Weeks.
Interproximal Plaque Score after 12 weeks
|
2.64 Units on a scale
Standard Error 0.028
|
3.01 Units on a scale
Standard Error 0.022
|
|
Plaque Control (Overall and Interproximal Dental Plaque Scores) Using Turesky Modification of Quigley &Amp; Hein Plaque Index at 6, 12 and 24 Weeks.
Overall Plaque Score at Baseline
|
3.04 Units on a scale
Standard Error 0.019
|
3.00 Units on a scale
Standard Error 0.019
|
|
Plaque Control (Overall and Interproximal Dental Plaque Scores) Using Turesky Modification of Quigley &Amp; Hein Plaque Index at 6, 12 and 24 Weeks.
Overall Plaque Score after 6 weeks
|
2.65 Units on a scale
Standard Error 0.030
|
2.98 Units on a scale
Standard Error 0.021
|
|
Plaque Control (Overall and Interproximal Dental Plaque Scores) Using Turesky Modification of Quigley &Amp; Hein Plaque Index at 6, 12 and 24 Weeks.
Overall Plaque Score after 12 weeks
|
2.55 Units on a scale
Standard Error 0.029
|
2.92 Units on a scale
Standard Error 0.025
|
|
Plaque Control (Overall and Interproximal Dental Plaque Scores) Using Turesky Modification of Quigley &Amp; Hein Plaque Index at 6, 12 and 24 Weeks.
Overall Plaque Score after 24 weeks
|
2.52 Units on a scale
Standard Error 0.032
|
2.95 Units on a scale
Standard Error 0.020
|
|
Plaque Control (Overall and Interproximal Dental Plaque Scores) Using Turesky Modification of Quigley &Amp; Hein Plaque Index at 6, 12 and 24 Weeks.
Interproximal Plaque Score at Baseline
|
3.12 Units on a scale
Standard Error 0.019
|
3.08 Units on a scale
Standard Error 0.018
|
|
Plaque Control (Overall and Interproximal Dental Plaque Scores) Using Turesky Modification of Quigley &Amp; Hein Plaque Index at 6, 12 and 24 Weeks.
Interproximal Plaque Score after 6 weeks
|
2.73 Units on a scale
Standard Error 0.029
|
3.05 Units on a scale
Standard Error 0.020
|
|
Plaque Control (Overall and Interproximal Dental Plaque Scores) Using Turesky Modification of Quigley &Amp; Hein Plaque Index at 6, 12 and 24 Weeks.
Interproximal Plaque Score after 24 weeks
|
2.61 Units on a scale
Standard Error 0.031
|
3.03 Units on a scale
Standard Error 0.019
|
Adverse Events
Sodium Bicarbonate Dentrifice
0% Sodium Bicarbonate Dentrifice
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sodium Bicarbonate Dentrifice
n=124 participants at risk
Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
|
0% Sodium Bicarbonate Dentrifice
n=123 participants at risk
Toothpaste containing 1100 ppm fluoride as sodium fluoride
|
|---|---|---|
|
Injury, poisoning and procedural complications
MOUTH INJURY
|
2.4%
3/124
|
2.4%
3/123
|
|
Injury, poisoning and procedural complications
PROCEDURAL PAIN
|
0.81%
1/124
|
0.81%
1/123
|
|
Injury, poisoning and procedural complications
THERMAL BURN
|
0.81%
1/124
|
0.81%
1/123
|
|
Infections and infestations
BRONCHITIS
|
0.81%
1/124
|
0.00%
0/123
|
|
Infections and infestations
NASOPHARYNGITIS
|
0.00%
0/124
|
0.81%
1/123
|
|
Respiratory, thoracic and mediastinal disorders
OVARIAN CYST RUPTURED
|
0.81%
1/124
|
0.00%
0/123
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/124
|
0.81%
1/123
|
|
Gastrointestinal disorders
GINGIVAL PAIN
|
0.00%
0/124
|
0.81%
1/123
|
|
Gastrointestinal disorders
SENSITIVITY OF TEETH
|
0.00%
0/124
|
0.81%
1/123
|
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