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NCT02207400 · ClinicalTrials.gov registry record · Phase 2

To Evaluate Efficacy and Tolerability of Sodium Bicarbonate Toothpaste and Its Effect on Opportunistic or Resistant Organisms

A Phase 2 study, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 2
Development phase
246
Enrollment target

NCT02207400: Completed Phase 2 study, sponsored by GlaxoSmithKline.

NCT02207400 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 246 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02207400, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 2
Development phase
246 participants
Enrollment target

Study Summary

This study will compare the Gingival Bleeding and Gingival Inflammation following twice daily use of a sodium bicarbonate experimental dentifrice compared to a 0% sodium bicarbonate toothpaste after 24 weeks of use. The study will be conducted at Salus Research, Inc. Participants will be recruited from their database and by use of an external recruitment agency

Primary Outcome

The Bleeding Index was performed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed

Interventions

  • DRUG Sodium fluoride
  • DRUG Sodium bicarbonate and sodium fluoride

Trial Details

FieldValue
Enrollment Target 246 participants
Start Date 2014-08-25
Est. Completion 2015-04-30
Phase Phase 2
GlaxoSmithKline

1,345 total trials

What the finished NCT02207400 record still lists

NCT02207400 is an interventional study that assigns participants to a tested intervention. The registered 246 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% higher).

The record links to 0 conditions, and to 2 interventions - of which Sodium fluoride is the first listed.

NCT02207400 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02207400 about?

NCT02207400 is a clinical study titled "To Evaluate Efficacy and Tolerability of Sodium Bicarbonate Toothpaste and Its Effect on Opportunistic or Resistant Organisms". This study will compare the Gingival Bleeding and Gingival Inflammation following twice daily use of a sodium bicarbonate experimental dentifrice compared to a 0% sodium bicarbonate toothpaste after 24 weeks of use. The study will be conducted at Salus Research, Inc. Participants will be recruited f...

What is the current status of trial NCT02207400?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 246 participants. The study started on 2014-08-25. Estimated completion is 2015-04-30.

What interventions are being tested in trial NCT02207400?

The interventions under investigation include: Sodium fluoride (DRUG), Sodium bicarbonate and sodium fluoride (DRUG).

Who is sponsoring clinical trial NCT02207400?

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 NCT02207400's enrollment target sits among peer trials

246 234th of 2000 higher than 1,767 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 NCT02207400, the US trial registry maintained by the National Library of Medicine. NCT02207400 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.