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Comparison · NCT02647203-sae

High Fluoride Toothpaste vs Standard Fluoride Toothpaste: 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. High Fluoride Toothpaste vs Standard Fluoride Toothpaste: serious adverse events. Trial comparisons, record NCT02647203-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02647203-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 1000.0263wilson
Risk in group 200.000000000000000001730.0271wilson
Risk difference, group 1 minus group 20-0.02710.0263newcombe 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 1High Fluoride Toothpaste
5,000 ppm fluoridated toothpaste, high concentration. Self-administered fluoridated dentifrices. By the elderly subjects, twice per day Drug (including placebo)~Self-administered fluoridated dentifrices: Elderly participants will be instructed to self administer toothpastes, twice per day. Toothpastes will be provided.
0142EG000
Group 2Standard Fluoride Toothpaste
1,450 ppm fluoridated toothpaste, low concentration. Self-administered fluoridated dentifrices. By the elderly subjects, twice per day Drug (including placebo)~Self-administered fluoridated dentifrices: Elderly participants will be instructed to self administer toothpastes, twice per day. Toothpastes will be provided.
0138EG001

Harm

What it counts
Total, serious adverse events
Time frame

Source ClinicalTrials.gov

Trial

Title
Non-invasive Treatment of Root Caries in Older Adults
NCT number
NCT02647203
Phases
PHASE1, PHASE2
Conditions
Root Caries
Interventions
Self-administered fluoridated dentifrices
Lead sponsor
University of Talca
Results first posted
2021-01-05

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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