Oral Hygiene
Conditions
Brief summary
The primary objectives of this study will be to compare the Gingival Bleeding and Gingival Inflammation following twice daily use of a sodium bicarbonate experimental dentifrice compared to a 0% sodium bicarbonate toothpaste after 24 weeks of use. The study will be conducted at Silverstone Research Group. Participants will be recruited from their database and by use of an external recruitment agency.
Interventions
DRUGSodium bicarbonate plus sodium fluoride
Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
DRUGSodium fluoride
Toothpaste containing 1100 ppm fluoride as sodium fluoride
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or oral/dental examination. * A minimum of 20 permanent gradable teeth * Moderate gingivitis present at the screening visit in the opinion of the investigator * A total of 20 bleeding sites or greater at baseline visit * Positive response to bleeding on brushing present at the screening visit
Exclusion criteria
* Pregnant or breast feeding women * Tobacco chewers * Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any other medical condition (e.g. Diabetes Mellitus) that would make the participant unlikely to fully complete the study or any that increases the risk to the participants or undermines the data validity. * Recent history (within the last year) of alcohol or other substance abuse * Participants requiring prophylactic antibiotic treatment prior to dental therapy * Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients * Have current active caries or any medical conditions which may directly influence gingival bleeding * Use of concomitant or any systemic medication that, in the opinion of the investigator, might interfere with the outcome of the study or have an effect on gingival conditions within 14 days of gingival examinations * Excessive calculus present that interferes with the probing examination for Gingival Bleeding Index * Participation in another clinical study or receipt of an investigational drug or oral care product within 30 days of the screening visit * An employee of the sponsor or the study site or members or their immediate family.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Gingival Bleeding Sites at 24 Weeks | Baseline, 24 weeks | 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. |
| Modified Gingival Index (MGI) at 24 Weeks | Baseline, 24 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Gingival Bleeding Sites at 6 and 12 Weeks. | Baseline, 6 and 12 weeks | 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. |
| Modified Gingival Index (MGI) at 6 and 12 Weeks. | Baseline, 6 and 12 weeks | 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 |
| Bleeding Index at 6, 12 and 24 Weeks | Baseline, 6, 12 and 24 weeks | 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 |
| Plaque Control (Overall and Interproximal Dental Plaque Scores) Using Turesky Modification of Quigley &Amp; Hein Plaque Index at 6, 12 and 24 Weeks. | Baseline, 6,12 and 24 weeks | 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 |
Countries
United States
Participant flow
Recruitment details
The participants were recruited at a clinical site in the USA.
Participants by arm
| Arm | Count |
|---|---|
| Sodium Bicarbonate Dentrifice Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride | 124 |
| 0% Sodium Bicarbonate Dentrifice Toothpaste containing 1100 ppm fluoride as sodium fluoride | 123 |
| Total | 247 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not meet study criteria | 3 | 0 |
| Overall Study | Lost to Follow-up | 3 | 1 |
| Overall Study | Pregnancy | 0 | 1 |
| Overall Study | Withdrawal by Subject | 5 | 6 |
Baseline characteristics
| Characteristic | Sodium Bicarbonate Dentrifice | 0% Sodium Bicarbonate Dentrifice | Total |
|---|---|---|---|
| Age, Continuous | 34.52 Years STANDARD_DEVIATION 13.162 | 37.55 Years STANDARD_DEVIATION 13.977 | 36.03 Years STANDARD_DEVIATION 13.631 |
| Sex: Female, Male Female | 69 Participants | 72 Participants | 141 Participants |
| Sex: Female, Male Male | 55 Participants | 51 Participants | 106 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 7 / 124 | 8 / 123 |
| serious Total, serious adverse events | 0 / 124 | 0 / 123 |
Outcome results
Primary
Modified Gingival Index (MGI) at 24 Weeks
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
Time frame: Baseline, 24 weeks
Population: Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sodium Bicarbonate Dentrifice | Modified Gingival Index (MGI) at 24 Weeks | Modified Gingival Index at Baseline | 2.53 Units on a scale | Standard Error 0.017 |
| Sodium Bicarbonate Dentrifice | Modified Gingival Index (MGI) at 24 Weeks | Modified Gingival Index after 24 weeks | 2.23 Units on a scale | Standard Error 0.021 |
| 0% Sodium Bicarbonate Dentrifice | Modified Gingival Index (MGI) at 24 Weeks | Modified Gingival Index at Baseline | 2.54 Units on a scale | Standard Error 0.018 |
| 0% Sodium Bicarbonate Dentrifice | Modified Gingival Index (MGI) at 24 Weeks | Modified Gingival Index after 24 weeks | 2.43 Units on a scale | Standard Error 0.21 |
p-value: <0.000195% CI: [-0.237, -0.165]ANCOVA
Primary
Number of Gingival Bleeding Sites at 24 Weeks
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.
Time frame: Baseline, 24 weeks
Population: Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sodium Bicarbonate Dentrifice | 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 |
| Sodium Bicarbonate Dentrifice | 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 |
| 0% Sodium Bicarbonate Dentrifice | Number of Gingival Bleeding Sites at 24 Weeks | Number of Bleeding Sites at Baseline | 45.84 number of gingival bleeding sites | Standard Error 1.448 |
| 0% Sodium Bicarbonate Dentrifice | Number of Gingival Bleeding Sites at 24 Weeks | Number of Bleeding sites after 24 weeks | 36.39 number of gingival bleeding sites | Standard Error 1.51 |
p-value: <0.000195% CI: [-20.317, -14.664]ANCOVA
Secondary
Bleeding Index at 6, 12 and 24 Weeks
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
Time frame: Baseline, 6, 12 and 24 weeks
Population: Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sodium Bicarbonate Dentrifice | Bleeding Index at 6, 12 and 24 Weeks | Bleeding Index Score at Baseline | 0.45 Units on a Scale | Standard Error 0.014 |
| Sodium Bicarbonate Dentrifice | Bleeding Index at 6, 12 and 24 Weeks | Bleeding Index Score after 6 weeks | 0.25 Units on a Scale | Standard Error 0.01 |
| Sodium Bicarbonate Dentrifice | Bleeding Index at 6, 12 and 24 Weeks | Bleeding Index Score after 12 weeks | 0.21 Units on a Scale | Standard Error 0.009 |
| Sodium Bicarbonate Dentrifice | 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% Sodium Bicarbonate Dentrifice | Bleeding Index at 6, 12 and 24 Weeks | Bleeding Index Score after 24 weeks | 0.37 Units on a Scale | Standard Error 0.014 |
| 0% Sodium Bicarbonate Dentrifice | Bleeding Index at 6, 12 and 24 Weeks | Bleeding Index Score at Baseline | 0.47 Units on a Scale | Standard Error 0.014 |
| 0% Sodium Bicarbonate Dentrifice | Bleeding Index at 6, 12 and 24 Weeks | Bleeding Index Score after 12 weeks | 0.35 Units on a Scale | Standard Error 0.012 |
| 0% Sodium Bicarbonate Dentrifice | Bleeding Index at 6, 12 and 24 Weeks | Bleeding Index Score after 6 weeks | 0.41 Units on a Scale | Standard Error 0.014 |
Secondary
Modified Gingival Index (MGI) at 6 and 12 Weeks.
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
Time frame: Baseline, 6 and 12 weeks
Population: Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sodium Bicarbonate Dentrifice | Modified Gingival Index (MGI) at 6 and 12 Weeks. | Modified Gingival Index at Baseline | 2.53 Units on a scale | Standard Error 0.017 |
| Sodium Bicarbonate Dentrifice | 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 |
| Sodium Bicarbonate Dentrifice | 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 |
| 0% Sodium Bicarbonate Dentrifice | Modified Gingival Index (MGI) at 6 and 12 Weeks. | Modified Gingival Index at Baseline | 2.54 Units on a scale | Standard Error 0.018 |
| 0% Sodium Bicarbonate Dentrifice | Modified Gingival Index (MGI) at 6 and 12 Weeks. | Modified Gingival Index after 6 weeks | 2.45 Units on a scale | Standard Error 0.018 |
| 0% Sodium Bicarbonate Dentrifice | Modified Gingival Index (MGI) at 6 and 12 Weeks. | Modified Gingival Index after 12 weeks | 2.40 Units on a scale | Standard Error 0.018 |
Secondary
Number of Gingival Bleeding Sites at 6 and 12 Weeks.
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.
Time frame: Baseline, 6 and 12 weeks
Population: Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sodium Bicarbonate Dentrifice | 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 |
| Sodium Bicarbonate Dentrifice | 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 |
| Sodium Bicarbonate Dentrifice | 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 |
| 0% Sodium Bicarbonate Dentrifice | Number of Gingival Bleeding Sites at 6 and 12 Weeks. | Number of Bleeding sites after 12 weeks | 34.23 number of gingival bleeding sites | Standard Error 1.26 |
| 0% Sodium Bicarbonate Dentrifice | Number of Gingival Bleeding Sites at 6 and 12 Weeks. | Number of Bleeding Sites at Baseline | 45.84 number of gingival bleeding sites | Standard Error 1.448 |
| 0% Sodium Bicarbonate Dentrifice | Number of Gingival Bleeding Sites at 6 and 12 Weeks. | Number of Bleeding Sites after 6 weeks | 40.27 number of gingival bleeding sites | Standard Error 1.448 |
Secondary
Plaque Control (Overall and Interproximal Dental Plaque Scores) Using Turesky Modification of Quigley &Amp; Hein Plaque Index at 6, 12 and 24 Weeks.
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
Time frame: Baseline, 6,12 and 24 weeks
Population: Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sodium Bicarbonate Dentrifice | 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 |
| Sodium Bicarbonate Dentrifice | 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 0.03 |
| Sodium Bicarbonate Dentrifice | 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 |
| Sodium Bicarbonate Dentrifice | 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 |
| Sodium Bicarbonate Dentrifice | 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 |
| Sodium Bicarbonate Dentrifice | 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 |
| Sodium Bicarbonate Dentrifice | 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 |
| Sodium Bicarbonate Dentrifice | 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 |
| 0% Sodium Bicarbonate Dentrifice | 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 | 3.03 Units on a scale | Standard Error 0.019 |
| 0% Sodium Bicarbonate Dentrifice | 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 | 3.00 Units on a scale | Standard Error 0.019 |
| 0% Sodium Bicarbonate Dentrifice | 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 | 3.08 Units on a scale | Standard Error 0.018 |
| 0% Sodium Bicarbonate Dentrifice | 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 | 2.98 Units on a scale | Standard Error 0.021 |
| 0% Sodium Bicarbonate Dentrifice | 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 | 3.01 Units on a scale | Standard Error 0.022 |
| 0% Sodium Bicarbonate Dentrifice | 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 | 2.92 Units on a scale | Standard Error 0.025 |
| 0% Sodium Bicarbonate Dentrifice | 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 | 3.05 Units on a scale | Standard Error 0.02 |
| 0% Sodium Bicarbonate Dentrifice | 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 | 2.95 Units on a scale | Standard Error 0.02 |