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NCT01128972 · ClinicalTrials.gov registry record · Phase 2

Evaluation of a Test Mouthwash and Dentifrice Regimen in an In-situ Model of Dental Erosion

A Phase 2 study, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 2
Development phase
36
Enrollment target

NCT01128972: Completed Phase 2 study, sponsored by GlaxoSmithKline.

NCT01128972 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 36 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01128972, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 2
Development phase
36 participants
Enrollment target

Study Summary

An in situ model will be used to evaluate and compare enamel remineralization of bovine enamel specimens.

Primary Outcome

Enamel specimens were exposed to dietary erosive challenge and set of five indentations within each specimen was measured. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine NER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent NER was calculated by formula: \[(E1-E2)/ (E1-B)\]\*100. Smaller

Interventions

  • DRUG Sodium monoflurophosphate
  • DRUG Sterile water
  • DRUG Sodium fluoride

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2009-08
Est. Completion 2009-10
Phase Phase 2
GlaxoSmithKline

1,345 total trials

What the finished NCT01128972 record still lists

NCT01128972 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower).

The record links to 0 conditions, and to 3 interventions - of which Sodium monoflurophosphate is the first listed.

NCT01128972 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01128972 about?

NCT01128972 is a clinical study titled "Evaluation of a Test Mouthwash and Dentifrice Regimen in an In-situ Model of Dental Erosion". An in situ model will be used to evaluate and compare enamel remineralization of bovine enamel specimens.

What is the current status of trial NCT01128972?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2009-08. Estimated completion is 2009-10.

What interventions are being tested in trial NCT01128972?

The interventions under investigation include: Sodium monoflurophosphate (DRUG), Sterile water (DRUG), Sodium fluoride (DRUG).

Who is sponsoring clinical trial NCT01128972?

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 NCT01128972's enrollment target sits among peer trials

36 1496th of 2000 higher than 477 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT01128972, the US trial registry maintained by the National Library of Medicine. NCT01128972 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.