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Comparison · NCT02207400-sae

Sodium Bicarbonate and Sodium Fluoride Dentifrice vs Sodium Fluoride Dentifrice: serious adverse events

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Sodium Bicarbonate and Sodium Fluoride Dentifrice vs Sodium Fluoride Dentifrice: serious adverse events. Trial comparisons, record NCT02207400-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02207400-sae

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 1000.0303wilson
Risk in group 2000.0303wilson
Risk difference, group 1 minus group 20-0.03030.0303newcombe hybrid score
Risk ratio, group 1 over group 2loga group has no participants with the outcome
Odds ratio, group 1 over group 2loga cell of the two-by-two table is zero
Number needed to harmfrom the risk difference intervalthe two groups' risks are equal

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Sodium Bicarbonate and Sodium Fluoride DentifriceExperimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 ppm fluoride as sodium fluoride0123EG000
Group 2Sodium Fluoride DentifriceToothpaste containing 1100 ppm fluoride as sodium fluoride0123EG001

Harm

What it counts
Total, serious adverse events
Time frame
Adverse events were collected throughout the study from the start of the washout period, until five days following last treatment.

Source ClinicalTrials.gov

Trial

Title
To Evaluate Efficacy and Tolerability of Sodium Bicarbonate Toothpaste and Its Effect on Opportunistic or Resistant Organisms
NCT number
NCT02207400
Phases
PHASE2
Conditions
Oral Hygiene
Interventions
Sodium bicarbonate and sodium fluoride, Sodium fluoride
Lead sponsor
GlaxoSmithKline
Results first posted
2016-07-26

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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