CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 246 enrolled
Drug / intervention
Sodium bicarbonate and sodium fluoride +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02207400
NCT02207400Phase 2Completed
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A Six Month Clinical Study Based in the US to Evaluate the Efficacy and Tolerability of Sodium Bicarbonate Toothpaste and Its Effect on Opportunistic or Resistant Organisms

GlaxoSmithKline·interventional·Posted Aug 4, 2014·Updated Jul 31, 2018

In Brief

A Phase 2 clinical trial evaluating Sodium bicarbonate and sodium fluoride and Sodium fluoride for Oral Hygiene. Completed, enrolled 246 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOral Hygiene
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 4, 2014
Enrollment StartAug 25, 2014
Primary CompletionFeb 1, 2015
Study CompletionApr 30, 2015
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 11.9 years ago

Interventions

Sodium bicarbonate and sodium fluoridedrug

Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 parts per million (ppm) fluoride as sodium fluoride

Sodium fluoridedrug

Comparator toothpaste containing 1100 ppm fluoride as sodium fluoride