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To Evaluate the Efficacy and Tolerability of Sodium Bicarbonate Toothpaste

NCT02207907 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 247

Last updated 2017-04-13

Study results available
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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.

Conditions

  • Oral Hygiene

Interventions

DRUG

Sodium bicarbonate plus sodium fluoride

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

DRUG

Sodium fluoride

Toothpaste containing 1100 ppm fluoride as sodium fluoride

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2015-02-28
Completion
2015-03-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02207907 on ClinicalTrials.gov