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bicarbonate plus fluoride · 2 trials · 1 indication
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
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
| Arm | Type | Description |
|---|---|---|
| Experimental Dentifrice | EXPERIMENTAL | Participants were advised to brush their teeth with experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride |
| Reference Dentifrice | ACTIVE_COMPARATOR | Participants were advised to brush their teeth with reference dentifrice containing 1100ppm fluoride as sodium fluoride |
| Sodium bicarbonate plus sodium fluoride | EXPERIMENTAL | Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride |
| Sodium fluoride | ACTIVE_COMPARATOR | Toothpaste containing 1100 ppm fluoride as sodium fluoride |
| Name | Type | Description |
|---|---|---|
| Sodium bicarbonate and sodium fluoride | DRUG | Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 parts per million (ppm) fluoride as sodium fluoride |
| Sodium fluoride | DRUG | Comparator toothpaste containing 1100 ppm fluoride as sodium fluoride |
| Sodium bicarbonate plus sodium fluoride | DRUG | Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride |
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 t...
Bicarbonate plus fluoride is an investigational small molecule being developed for oral hygiene. It is formulated as a toothpaste containing sodium bicarbonate and fluoride, intended to support dental health. The product is currently in Phase 2 clinical development, with studies evaluating its efficacy and tolerability in healthy adults.
Bicarbonate plus fluoride is being developed by GSK plc, a global biopharma company traded on the New York Stock Exchange under the ticker GSK. GSK is conducting clinical trials to evaluate the toothpaste's efficacy and tolerability for oral hygiene purposes.
Bicarbonate plus fluoride is in Phase 2 clinical development. Two Phase 2 trials have been completed, both evaluating the efficacy and tolerability of sodium bicarbonate toothpaste in healthy adults for oral hygiene. The product is investigational and not yet approved for marketing.
Bicarbonate plus fluoride has two completed Phase 2 trials: NCT02207400, which evaluated efficacy and tolerability of sodium bicarbonate toothpaste and its effect on opportunistic or resistant organisms, and NCT02207907, which evaluated efficacy and tolerability of the toothpaste. Both enrolled healthy adults in the United States.
Yes, bicarbonate plus fluoride refers to a toothpaste formulation containing sodium bicarbonate and fluoride. The clinical trials for this product are titled as evaluating sodium bicarbonate toothpaste, indicating that bicarbonate plus fluoride is the active combination being tested for oral hygiene.