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NCT01128946 · ClinicalTrials.gov registry record · Phase 4

Enamel Remineralization Potential of Dentifrices in Situ

A Phase 4 study of Dental Caries, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 4
Development phase
83
Enrollment target
1
Study location

NCT01128946: Completed Phase 4 study of Dental Caries, sponsored by GlaxoSmithKline.

NCT01128946 is a Phase 4 study of Dental Caries that has completed, run by GlaxoSmithKline. The registered enrollment target is 83 participants, below the 719-participant average among 30 other Dental Caries trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01128946, a Phase 4 study of Dental Caries, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 4
Development phase
83 participants
Enrollment target
1
Study location

Study Summary

This study will use an oral in-situ caries model to study remineralization of enamel due to the action of different combinations of fluoride salts delivered from dentifrices.

Primary Outcome

SMH test was used to assess mineral status of partially demineralized enamel specimens using Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening/demineralization, while decrease in the indentation represents rehardening/ remineralization of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline(B), aft

Conditions Studied

Interventions

  • DRUG NaF
  • DRUG SnF
  • DRUG NaMFP

Study Locations (1)

Indiana

  • Indiana University School of Dentistry - Indianapolis

Trial Details

FieldValue
Enrollment Target 83 participants
Start Date 2009-11
Est. Completion 2010-03
Phase Phase 4
GlaxoSmithKline

1,345 total trials

What the finished NCT01128946 record still lists

NCT01128946 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 83 participants, a relatively small participant target, below the 719-participant average among 30 other Dental Caries trials with a reported enrollment target (88% lower).

The record links to 1 condition, with Dental Caries appearing as the primary indexed condition, and to 3 interventions - of which NaF is the first listed.

NCT01128946 reports a single indexed study location in Indiana.

Frequently Asked Questions

What is clinical trial NCT01128946 about?

NCT01128946 is a clinical study titled "Enamel Remineralization Potential of Dentifrices in Situ". This study will use an oral in-situ caries model to study remineralization of enamel due to the action of different combinations of fluoride salts delivered from dentifrices.

What is the current status of trial NCT01128946?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 83 participants. The study started on 2009-11. Estimated completion is 2010-03.

What conditions does trial NCT01128946 study?

This clinical trial studies the following conditions: Dental Caries.

What interventions are being tested in trial NCT01128946?

The interventions under investigation include: NaF (DRUG), SnF (DRUG), NaMFP (DRUG).

Who is sponsoring clinical trial NCT01128946?

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

Where is trial NCT01128946 being conducted?

This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Dental Caries

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01128946's enrollment target sits among peer trials

83 12th of 30 higher than 19 of 30 other Dental Caries trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Dental Caries 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 NCT01128946, the US trial registry maintained by the National Library of Medicine. NCT01128946 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.