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Trial record 14 of 292 for:    Sodium Fluoride OR Duraphat

To Evaluate the Efficacy and Tolerability of Sodium Bicarbonate Toothpaste

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ClinicalTrials.gov Identifier: NCT02207907
Recruitment Status : Completed
First Posted : August 4, 2014
Results First Posted : February 17, 2017
Last Update Posted : April 13, 2017
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 plus sodium fluoride
Drug: Sodium fluoride
Enrollment 247
Recruitment Details The participants were recruited at a clinical site in the USA.
Pre-assignment Details  
Arm/Group Title Sodium Bicarbonate Dentrifice 0% Sodium Bicarbonate Dentrifice
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
Period Title: Overall Study
Started 124 123
Completed 113 115
Not Completed 11 8
Reason Not Completed
Lost to Follow-up             3             1
Withdrawal by Subject             5             6
Did not meet study criteria             3             0
Pregnancy             0             1
Arm/Group Title Sodium Bicarbonate Dentrifice 0% Sodium Bicarbonate Dentrifice Total
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 Total of all reporting groups
Overall Number of Baseline Participants 124 123 247
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 124 participants 123 participants 247 participants
34.52  (13.162) 37.55  (13.977) 36.03  (13.631)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 124 participants 123 participants 247 participants
Female
69
  55.6%
72
  58.5%
141
  57.1%
Male
55
  44.4%
51
  41.5%
106
  42.9%
1.Primary Outcome
Title Number of Gingival Bleeding Sites at 24 Weeks
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement.
Arm/Group Title Sodium Bicarbonate Dentrifice 0% Sodium Bicarbonate Dentrifice
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 118 122
Mean (Standard Error)
Unit of Measure: number of gingival bleeding sites
Number of Bleeding Sites at Baseline 45.13  (1.393) 45.84  (1.448)
Number of Bleeding sites after 24 weeks 18.67  (1.142) 36.39  (1.510)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sodium Bicarbonate Dentrifice, 0% Sodium Bicarbonate Dentrifice
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 From ANCOVA analysis with treatment group and smoking status as factors and baseline MGI and BI as covariates
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -17.491
Confidence Interval (2-Sided) 95%
-20.317 to -14.664
Estimation Comments Difference is first named treatment minus second named treatment such that a negative difference favors the first named treatment.
2.Primary Outcome
Title Modified Gingival Index (MGI) at 24 Weeks
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement
Arm/Group Title Sodium Bicarbonate Dentrifice 0% Sodium Bicarbonate Dentrifice
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 118 122
Mean (Standard Error)
Unit of Measure: Units on a scale
Modified Gingival Index at Baseline 2.53  (0.017) 2.54  (0.018)
Modified Gingival Index after 24 weeks 2.23  (0.021) 2.43  (0.210)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sodium Bicarbonate Dentrifice, 0% Sodium Bicarbonate Dentrifice
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 From ANCOVA analysis with treatment group and smoking status as factors and baseline MGI and BI as covariates
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -0.201
Confidence Interval (2-Sided) 95%
-0.237 to -0.165
Estimation Comments Difference is first named treatment minus second named treatment 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 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement
Arm/Group Title Sodium Bicarbonate Dentrifice 0% Sodium Bicarbonate
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 118 122
Mean (Standard Error)
Unit of Measure: number of gingival bleeding sites
Number of Bleeding Sites at Baseline 45.13  (1.393) 45.84  (1.448)
Number of Bleeding Sites after 6 weeks 25.40  (0.999) 40.27  (1.448)
Number of Bleeding sites after 12 weeks 20.83  (0.915) 34.23  (1.260)
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 Baseline, 6 and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement
Arm/Group Title Sodium Bicarbonate Dentrifice 0% Sodium Bicarbonate Dentrifice
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 118 122
Mean (Standard Error)
Unit of Measure: Units on a scale
Modified Gingival Index at Baseline 2.53  (0.017) 2.54  (0.018)
Modified Gingival Index after 6 weeks 2.28  (0.017) 2.45  (0.018)
Modified Gingival Index after 12 weeks 2.24  (0.018) 2.40  (0.018)
5.Secondary Outcome
Title Bleeding Index at 6, 12 and 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 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement
Arm/Group Title Sodium Bicarbonate Dentrifice 0% Sodium Bicarbonate Dentrifice
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 118 122
Mean (Standard Error)
Unit of Measure: Units on a Scale
Bleeding Index Score at Baseline 0.45  (0.014) 0.47  (0.014)
Bleeding Index Score after 6 weeks 0.25  (0.010) 0.41  (0.014)
Bleeding Index Score after 12 weeks 0.21  (0.009) 0.35  (0.012)
Bleeding Index Score after 24 weeks 0.19  (0.012) 0.37  (0.014)
6.Secondary Outcome
Title Plaque Control (Overall and Interproximal Dental Plaque Scores) Using Turesky Modification of Quigley &Amp; Hein Plaque Index at 6, 12 and 24 Weeks.
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement
Arm/Group Title Sodium Bicarbonate Dentrifice 0% Sodium Bicarbonate Dentrifice
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 118 122
Mean (Standard Error)
Unit of Measure: Units on a scale
Overall Plaque Score at Baseline 3.04  (0.019) 3.00  (0.019)
Overall Plaque Score after 6 weeks 2.65  (0.030) 2.98  (0.021)
Overall Plaque Score after 12 weeks 2.55  (0.029) 2.92  (0.025)
Overall Plaque Score after 24 weeks 2.52  (0.032) 2.95  (0.020)
Interproximal Plaque Score at Baseline 3.12  (0.019) 3.08  (0.018)
Interproximal Plaque Score after 6 weeks 2.73  (0.029) 3.05  (0.020)
Interproximal Plaque Score after 12 weeks 2.64  (0.028) 3.01  (0.022)
Interproximal Plaque Score after 24 weeks 2.61  (0.031) 3.03  (0.019)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sodium Bicarbonate Dentrifice 0% Sodium Bicarbonate Dentrifice
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
All-Cause Mortality
Sodium Bicarbonate Dentrifice 0% Sodium Bicarbonate Dentrifice
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sodium Bicarbonate Dentrifice 0% Sodium Bicarbonate Dentrifice
Affected / at Risk (%) Affected / at Risk (%)
Total   0/124 (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 Dentrifice 0% Sodium Bicarbonate Dentrifice
Affected / at Risk (%) Affected / at Risk (%)
Total   7/124 (5.65%)   8/123 (6.50%) 
Gastrointestinal disorders     
ABDOMINAL PAIN  0/124 (0.00%)  1/123 (0.81%) 
GINGIVAL PAIN  0/124 (0.00%)  1/123 (0.81%) 
SENSITIVITY OF TEETH  0/124 (0.00%)  1/123 (0.81%) 
Infections and infestations     
BRONCHITIS  1/124 (0.81%)  0/123 (0.00%) 
NASOPHARYNGITIS  0/124 (0.00%)  1/123 (0.81%) 
Injury, poisoning and procedural complications     
MOUTH INJURY  3/124 (2.42%)  3/123 (2.44%) 
PROCEDURAL PAIN  1/124 (0.81%)  1/123 (0.81%) 
THERMAL BURN  1/124 (0.81%)  1/123 (0.81%) 
Respiratory, thoracic and mediastinal disorders     
OVARIAN CYST RUPTURED  1/124 (0.81%)  0/123 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02207907     History of Changes
Other Study ID Numbers: 202192
RH02433 ( Other Identifier: GSK )
First Submitted: July 31, 2014
First Posted: August 4, 2014
Results First Submitted: November 2, 2015
Results First Posted: February 17, 2017
Last Update Posted: April 13, 2017