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NCT01563172 · ClinicalTrials.gov registry record · Phase 4

Effect of Dentifrice Usage Regime on Delivery and Efficacy of Fluoride

A Phase 4 study, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 4
Development phase
65
Enrollment target

NCT01563172: Completed Phase 4 study, sponsored by GlaxoSmithKline.

NCT01563172 is a Phase 4 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 65 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01563172, a Phase 4 study, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 4
Development phase
65 participants
Enrollment target

Study Summary

This study will evaluate and compare the effect of the amount of toothpaste used and brushing time on enamel strengthening (percent of surface microhardness recovery, % SMHR) and enamel fluoride uptake (EFU).

Primary Outcome

SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. % SMH recovery was calculated from indentation length (micrometer \[μm\]) of sound ena

Interventions

  • DRUG Sodium fluoride / silica and carbopol, 0.5g
  • DRUG Sodium fluoride / silica and carbopol, 1.5g
  • OTHER Fluoride free dentifrice

Trial Details

FieldValue
Enrollment Target 65 participants
Start Date 2009-01-01
Est. Completion 2009-06-01
Phase Phase 4
GlaxoSmithKline

1,345 total trials

What the finished NCT01563172 record still lists

NCT01563172 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower).

The record links to 0 conditions, and to 3 interventions - of which Sodium fluoride / silica and carbopol, 0.5g is the first listed.

NCT01563172 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01563172 about?

NCT01563172 is a clinical study titled "Effect of Dentifrice Usage Regime on Delivery and Efficacy of Fluoride". This study will evaluate and compare the effect of the amount of toothpaste used and brushing time on enamel strengthening (percent of surface microhardness recovery, % SMHR) and enamel fluoride uptake (EFU).

What is the current status of trial NCT01563172?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 65 participants. The study started on 2009-01-01. Estimated completion is 2009-06-01.

What interventions are being tested in trial NCT01563172?

The interventions under investigation include: Sodium fluoride / silica and carbopol, 0.5g (DRUG), Sodium fluoride / silica and carbopol, 1.5g (DRUG), Fluoride free dentifrice (OTHER).

Who is sponsoring clinical trial NCT01563172?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01563172's enrollment target sits among peer trials

65 1091st of 2000 higher than 903 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01563172, the US trial registry maintained by the National Library of Medicine. NCT01563172 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.