To Evaluate the Efficacy and Tolerability of Sodium Bicarbonate Toothpaste

Study Overview
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Brief Summary
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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.

Official Title
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A Six Month Clinical Study Based in the US to Evaluate the Efficacy and Tolerability of Sodium Bicarbonate Toothpaste

Conditions
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Oral Hygiene

Intervention / Treatment
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* Drug: Sodium bicarbonate plus sodium fluoride
* Drug: Sodium fluoride


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sodium bicarbonate plus sodium fluoride<br>Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride | Drug: Sodium bicarbonate plus sodium fluoride<br>* Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride<br>|
| Active Comparator: Sodium fluoride<br>Toothpaste containing 1100 ppm fluoride as sodium fluoride | Drug: Sodium fluoride<br>* Toothpaste containing 1100 ppm fluoride as sodium fluoride<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, 24 weeks | 
| 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 | Baseline, 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, 6 and 12 weeks | 
| 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 | Baseline, 6 and 12 weeks | 
| 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 | Baseline, 6, 12 and 24 weeks | 
| 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 | Baseline, 6,12 and 24 weeks |