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bicarbonate plus fluoride

Phase 2

Oral Hygiene | Small molecule | Other |GSK plc|Last Updated: Jul 31, 2018

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment493
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02207400To Evaluate Efficacy and Tolerability of Sodium Bicarbonate Toothpaste and Its Effect on Opportunistic or Resistant OrganismsPHASE2 COMPLETED 246Aug 25, 2014Apr 30, 2015Jul 31, 20181 United States
NCT02207907To Evaluate the Efficacy and Tolerability of Sodium Bicarbonate ToothpastePHASE2 COMPLETED 247Aug 1, 2014Mar 1, 2015Apr 13, 20171 United States
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Study Endpoints
Primary Endpoints
Number of Gingival Bleeding Sites at 24 Weeks
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 used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed

Modified Gingival Index (MGI) at 24 Weeks
24 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

Secondary Endpoints
Number of Gingival Bleeding Sites at 6 and 12 Weeks
Baseline, 6 and 12 weeks
Modified Gingival Index (MGI)) at 6 and 12 Weeks.
6 and 12 weeks
Bleeding Index (BI) at 6, 12 and 24 Weeks
6, 12 and 24 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Experimental DentifriceEXPERIMENTALParticipants were advised to brush their teeth with experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
Reference DentifriceACTIVE_COMPARATORParticipants were advised to brush their teeth with reference dentifrice containing 1100ppm fluoride as sodium fluoride
Sodium bicarbonate plus sodium fluorideEXPERIMENTALExperimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
Sodium fluorideACTIVE_COMPARATORToothpaste containing 1100 ppm fluoride as sodium fluoride
Interventions
NameTypeDescription
Sodium bicarbonate and sodium fluorideDRUGExperimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 parts per million (ppm) fluoride as sodium fluoride
Sodium fluorideDRUGComparator toothpaste containing 1100 ppm fluoride as sodium fluoride
Sodium bicarbonate plus sodium fluorideDRUGExperimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:United States
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