CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 247 enrolled
Drug / intervention
Sodium bicarbonate plus 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/NCT02207907
NCT02207907Phase 2Completed
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A Six Month Clinical Study Based in the US to Evaluate the Efficacy and Tolerability of Sodium Bicarbonate Toothpaste

GlaxoSmithKline·interventional·Posted Aug 4, 2014·Updated Apr 13, 2017

In Brief

A Phase 2 clinical trial evaluating Sodium bicarbonate plus sodium fluoride and Sodium fluoride for Oral Hygiene. Completed, enrolled 247 participants across 1 site.

Detailed Summary

The primary objectives of this study will be to 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 Silverstone Research Group. 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 1, 2014
Primary CompletionFeb 1, 2015
Study CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 11.9 years ago

Interventions

Sodium bicarbonate plus sodium fluoridedrug

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

Sodium fluoridedrug

Toothpaste containing 1100 ppm fluoride as sodium fluoride