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To Evaluate Efficacy and Tolerability of Sodium Bicarbonate Toothpaste and Its Effect on Opportunistic or Resistant Organisms

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ClinicalTrials.gov Identifier: NCT02207400
Recruitment Status : Completed
First Posted : August 4, 2014
Results First Posted : July 26, 2016
Last Update Posted : July 31, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Oral Hygiene
Interventions Drug: Sodium bicarbonate and sodium fluoride
Drug: Sodium fluoride
Enrollment 246
Recruitment Details The participants were recruited at a clinical site in the USA.
Pre-assignment Details  
Arm/Group Title Sodium Bicarbonate and Sodium Fluoride Dentifrice Sodium Fluoride Dentifrice
Hide Arm/Group Description Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 parts per million (ppm) fluoride as sodium fluoride Toothpaste containing 1100 ppm fluoride as sodium fluoride
Period Title: Overall Study
Started 123 123
Completed 107 109
Not Completed 16 14
Reason Not Completed
Adverse Event             1             1
Lost to Follow-up             6             7
Protocol Violation             1             1
Withdrawal by Subject             8             4
Positive Urine Pregnancy Test             0             1
Arm/Group Title Sodium Bicarbonate and Sodium Fluoride Dentifrice Sodium Fluoride Dentifrice Total
Hide Arm/Group Description Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 parts per million (ppm) fluoride as sodium fluoride Toothpaste containing 1100 ppm fluoride as sodium fluoride Total of all reporting groups
Overall Number of Baseline Participants 123 123 246
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 123 participants 123 participants 246 participants
39.39  (14.284) 37.77  (12.615) 38.58  (13.473)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 123 participants 123 participants 246 participants
Female
74
  60.2%
78
  63.4%
152
  61.8%
Male
49
  39.8%
45
  36.6%
94
  38.2%
1.Primary Outcome
Title Number of Gingival Bleeding Sites at 24 Weeks
Hide Description 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 used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.
Arm/Group Title Sodium Bicarbonate and Sodium Fluoride Dentifrice Sodium Fluoride Dentifrice
Hide Arm/Group Description:
Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
Toothpaste containing 1100 ppm fluoride as sodium fluoride
Overall Number of Participants Analyzed 118 117
Mean (Standard Deviation)
Unit of Measure: Number of bleeding sites
13.24  (7.663) 24.90  (9.044)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sodium Bicarbonate and Sodium Fluoride Dentifrice, Sodium Fluoride Dentifrice
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -11.612
Confidence Interval (2-Sided) 95%
-13.191 to -10.033
Estimation Comments Difference is Sodium Bicarbonate and Sodium Fluoride Dentifrice minus Sodium Fluoride Dentifrice such that a negative difference favors the first named treatment.
2.Primary Outcome
Title Modified Gingival Index (MGI) at 24 Weeks
Hide Description 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 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.
Arm/Group Title Sodium Bicarbonate and Sodium Fluoride Dentifrice Sodium Fluoride Dentifrice
Hide Arm/Group Description:
Experimental dentifrice containing sodium bicarbonate plus 1150 ppm fluoride as sodium fluoride
Toothpaste containing 1100 ppm fluoride as sodium fluoride
Overall Number of Participants Analyzed 118 117
Mean (Standard Deviation)
Unit of Measure: Units on a scale
1.26  (0.505) 1.93  (0.408)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sodium Bicarbonate and Sodium Fluoride Dentifrice, Sodium Fluoride Dentifrice
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean difference
Estimated Value -0.652
Confidence Interval (2-Sided) 95%
-0.738 to -0.566
Estimation Comments Difference is Sodium Bicarbonate and Sodium Fluoride Dentifrice minus Sodium Fluoride Dentifrice such that a negative difference favors the first named treatment.
3.Secondary Outcome
Title Number of Gingival Bleeding Sites at 6 and 12 Weeks
Hide Description BI was performed 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 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 and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.
Arm/Group Title Sodium Bicarbonate and Sodium Fluoride Dentifrice Sodium Fluoride Dentifrice
Hide Arm/Group Description:
Experimental dentifrice containing sodium bicarbonate plus 1150 ppm fluoride as sodium fluoride
Toothpaste containing 1100 ppm fluoride as sodium fluoride
Overall Number of Participants Analyzed 118 117
Mean (Standard Deviation)
Unit of Measure: Number of bleeding sites
Number of Bleeding Sites at Baseline 29.76  (8.238) 29.05  (8.390)
Number of Bleeding Sites at 6 weeks 12.26  (9.339) 23.23  (10.993)
Number of Bleeding Sites at 12 weeks 15.73  (7.632) 23.86  (9.265)
4.Secondary Outcome
Title Modified Gingival Index (MGI)) at 6 and 12 Weeks.
Hide Description 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 6 and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.
Arm/Group Title Sodium Bicarbonate and Sodium Fluoride Dentifrice Sodium Fluoride Dentifrice
Hide Arm/Group Description:
Experimental dentifrice containing sodium bicarbonate plus 1150 ppm fluoride as sodium fluoride
Toothpaste containing 1100 ppm fluoride as sodium fluoride
Overall Number of Participants Analyzed 118 117
Mean (Standard Deviation)
Unit of Measure: Units on a scale
MGI at 6 weeks 1.50  (0.567) 1.96  (0.427)
MGI at 12 weeks 1.50  (0.536) 1.94  (0.464)
5.Secondary Outcome
Title Bleeding Index (BI) at 6, 12 and 24 Weeks
Hide Description BI was performed 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 used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed
Time Frame 6, 12 and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.
Arm/Group Title Sodium Bicarbonate and Sodium Fluoride Dentifrice Sodium Fluoride Dentifrice
Hide Arm/Group Description:
Experimental dentifrice containing sodium bicarbonate plus 1150 ppm fluoride as sodium fluoride
Toothpaste containing 1100 ppm fluoride as sodium fluoride
Overall Number of Participants Analyzed 118 117
Mean (Standard Deviation)
Unit of Measure: Units on a Scale
BI Score Score at 6 weeks 0.15  (0.133) 0.30  (0.172)
BI Score Score at 12 weeks 0.19  (0.112) 0.28  (0.135)
BI Score Score at 24 weeks 0.17  (0.116) 0.31  (0.159)
6.Secondary Outcome
Title Plaque Control (Overall and Interproximal Dental Plaque Scores) at 6, 12 and 24 Weeks.
Hide Description The dental examiner had used the Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth. Interproximal Dental Plaque Scores were analyzed in the same way as for Overall scores but just based on mesiofacial, facial, distofacial, mesiolingual, lingual and distolingual surfaces. Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5: 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 than 2/3 of the crown of the tooth; 5= Plaque covering 2/3 or more of the crown of the tooth.
Time Frame 6, 12 and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.
Arm/Group Title Sodium Bicarbonate and Sodium Fluoride Dentifrice Sodium Fluoride Dentifrice
Hide Arm/Group Description:
Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 ppm fluoride as sodium fluoride
Toothpaste containing 1100 ppm fluoride as sodium fluoride
Overall Number of Participants Analyzed 118 112
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Overall Plaque Score at 6 weeks 2.56  (0.536) 3.01  (0.411)
Overall Plaque Score at 12 weeks 2.54  (0.495) 2.90  (0.374)
Overall Plaque Score at 24 weeks 2.47  (0.437) 2.92  (0.399)
Interproximal Plaque Score at 6 weeks 2.78  (0.492) 3.19  (0.351)
Interproximal Plaque Score at 12 weeks 2.76  (0.437) 3.10  (0.311)
Interproximal Plaque Score at 24 weeks 2.71  (0.390) 3.11  (0.336)
7.Secondary Outcome
Title Bacterial Count at Baseline, After 6, 12, 24 and 32 Weeks
Hide Description Microbiological samples were collected at baseline, 6 weeks, 12 weeks, 24 weeks and 32 weeks. Plaque was harvested from contra-lateral 1st molar teeth, where no restorations are present, using a sterile paper point. The paper point was immersed into 4 ml of Calgon Ringer's solution in a sterile bijou and kept on ice until they can be taken to the laboratory for processing (within 24 hours).
Time Frame Baseline, 6, 12, 24 and 32 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.
Arm/Group Title Sodium Bicarbonate and Sodium Fluoride Dentifrice Sodium Fluoride Dentifrice
Hide Arm/Group Description:
Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 ppm)fluoride as sodium fluoride
Toothpaste containing 1100 ppm fluoride as sodium fluoride
Overall Number of Participants Analyzed 118 117
Mean (Standard Deviation)
Unit of Measure: colony forming units per sample
Staph Count at Baseline (n=24, 26) 0.2  (0.82) 0.2  (0.86)
Steph Count at 6 weeks (n=24, 26) 0.1  (0.34) 0  (0.20)
Steph Count at 12 weeks (n=24, 26) 1.8  (7.10) 3.2  (15.47)
Steph Count at 24 weeks (n=23, 25) 0.6  (1.59) 0.2  (0.37)
Steph Count at 32 weeks (n=21, 21) 0.2  (0.51) 0.1  (0.36)
Yeast Count at Baseline (n=24, 26) 203.4  (842.28) 647.8  (2958.78)
Yeast Count at 6 weeks (n=23, 26) 287.3  (1014.31) 784.3  (1796.75)
Yeast Count at 12 weeks (n=24, 25) 668.9  (812.81) 411.3  (906.19)
Yeast Count at 24 weeks (n=17, 22) 1479.6  (1165.48) 1522.3  (1008.13)
Yeast Count at 32 weeks (n= 14, 14) 2743.5  (2505.75) 1206.4  (1008.34)
Coliform count at Baseline (n= 24, 26) 3.9  (8.82) 3.8  (8.27)
Coliform count at 6 weeks (n= 24, 26) 2.6  (6.72) 5.7  (20.05)
Coliform count at 12 weeks (n= 24, 26) 10.9  (14.65) 26.9  (78.47)
Coliform count at 24 weeks (n=23, 25) 8.1  (16.86) 12.6  (19.24)
Coliform count at 32 weeks (n=21, 21) 10.9  (16.17) 17.8  (29.84)
E. Coli count at Baseline (n=24, 26) 0  (0) 0  (0.20)
E. Coli count at 6 weeks (n=24, 26) 0.1  (0.28) 0  (0.20)
E. Coli count at 12 weeks (n=24, 26) 0.1  (0.28) 0  (0)
E. Coli count at 24 weeks (n=23, 25) 0.3  (1.25) 0.2  (0.55)
E. Coli count at 32 weeks (n=21, 21) 0.6  (1.29) 0  (0.22)
Time Frame Adverse events were collected throughout the study from the start of the washout period, until five days following last treatment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sodium Bicarbonate and Sodium Fluoride Dentifrice Sodium Fluoride Dentifrice
Hide Arm/Group Description Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 ppm fluoride as sodium fluoride Toothpaste containing 1100 ppm fluoride as sodium fluoride
All-Cause Mortality
Sodium Bicarbonate and Sodium Fluoride Dentifrice Sodium Fluoride Dentifrice
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Sodium Bicarbonate and Sodium Fluoride Dentifrice Sodium Fluoride Dentifrice
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/123 (0.00%)      0/123 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sodium Bicarbonate and Sodium Fluoride Dentifrice Sodium Fluoride Dentifrice
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   17/123 (13.82%)      14/123 (11.38%)    
Endocrine disorders     
HYPOTHYROIDISM  1  1/123 (0.81%)  1 0/123 (0.00%)  0
Gastrointestinal disorders     
CHEILITIS  1  0/123 (0.00%)  0 1/123 (0.81%)  2
SENSITIVITY OF TEETH  1  1/123 (0.81%)  1 1/123 (0.81%)  1
APHTHOUS STOMATITIS  1  1/123 (0.81%)  1 0/123 (0.00%)  0
DIARRHOEA  1  0/123 (0.00%)  0 1/123 (0.81%)  1
GINGIVAL ULCERATION  1  1/123 (0.81%)  1 0/123 (0.00%)  0
MOUTH ULCERATION  1  0/123 (0.00%)  0 1/123 (0.81%)  1
TONGUE ULCERATION  1  1/123 (0.81%)  1 0/123 (0.00%)  0
Infections and infestations     
Cellulitis Orbital  1  2/123 (1.63%)  2 0/123 (0.00%)  0
Lower Respiratory Tract Infection  1  1/123 (0.81%)  2 0/123 (0.00%)  0
Pneumonia  1  2/123 (1.63%)  2 0/123 (0.00%)  0
Acute sinusitis  1  0/123 (0.00%)  0 1/123 (0.81%)  1
GASTROENTERITIS  1  1/123 (0.81%)  1 0/123 (0.00%)  0
PHARYNGITIS  1  0/123 (0.00%)  0 1/123 (0.81%)  1
PHARYNGITIS STREPTOCOCCAL  1  1/123 (0.81%)  1 0/123 (0.00%)  0
PULPITIS DENTAL  1  0/123 (0.00%)  0 1/123 (0.81%)  1
SINUSITIS  1  0/123 (0.00%)  0 1/123 (0.81%)  1
STAPHYLOCOCCAL INFECTION  1  1/123 (0.81%)  1 0/123 (0.00%)  0
TOOTH ABSCESS  1  1/123 (0.81%)  1 0/123 (0.00%)  0
GASTROENTERITIS VIRAL  1  0/123 (0.00%)  0 1/123 (0.81%)  1
Injury, poisoning and procedural complications     
MOUTH INJURY  1  4/123 (3.25%)  4 0/123 (0.00%)  0
TRAUMATIC ULCER  1  0/123 (0.00%)  0 3/123 (2.44%)  4
ARTHROPOD BITE  1  1/123 (0.81%)  1 0/123 (0.00%)  0
THERMAL BURN  1  0/123 (0.00%)  0 1/123 (0.81%)  1
Nervous system disorders     
BURNING SENSATION  1  1/123 (0.81%)  1 0/123 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
PULMONARY CONGESTION  1  0/123 (0.00%)  0 1/123 (0.81%)  1
Skin and subcutaneous tissue disorders     
INGROWING NAIL  1  1/123 (0.81%)  1 0/123 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02207400     History of Changes
Other Study ID Numbers: 202193
RH02434 ( Other Identifier: GSK )
First Submitted: July 21, 2014
First Posted: August 4, 2014
Results First Submitted: December 21, 2015
Results First Posted: July 26, 2016
Last Update Posted: July 31, 2018