CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 45 enrolled
Drug / intervention
Test zinc-IPMP toothpaste +4 moreother
Likely dose
Not stated in record
Key inclusion· 3
  • Demonstrates understanding of study procedures and provides voluntary written informed consent
  • Good general and mental health with no clinically significant abnormalities in medical history or oral examination
  • Plaque sample acidogenicity in the pH range 5.0 to 5.7
Key exclusion· 10
  • Pregnant, intending to become pregnant, or breast-feeding
  • Currently taking or have taken antibiotics within 2 weeks of plaque assessment
  • Medical history that may prevent participation, such as diabetes
  • Grossly carious lesions (active), moderate or severe periodontal conditions, or severe tooth wear

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

Search/NCT02856880
NCT02856880N/ACompleted

A Study to Investigate the Antimicrobial Activity of Two Test Toothpastes in a Plaque Glycolysis and Regrowth Model

GlaxoSmithKline·interventional·Posted Aug 5, 2016·Updated Aug 30, 2017

In Brief

A clinical study evaluating Test zinc-IPMP toothpaste, Test zinc non- IPMP toothpaste, and 3 other interventions for Dental Plaque. Completed, enrolled 45 participants across 1 site.

Detailed Summary

The aim of this exploratory study is to assess the ability of two test toothpastes containing 0.6% w/w zinc chloride stabilised with sodium citrate in a sodium lauryl sulfate (SLS)-containing base to reduce glycolytic metabolism and viability of de novo plaque bacteria using the plaque glycolysis regrowth model (PGRM).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDental Plaque
CountriesUnited Kingdom
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 5, 2016
Enrollment StartNov 9, 2015
Primary CompletionDec 1, 2015
Study CompletionDec 11, 2015
TodayJul 2, 2026
Enrollment to primary: 22 daysPosted 9.9 years ago

Interventions

Test zinc-IPMP toothpasteother

Test toothpaste containing 0.6% w/w zinc chloride and 0.1% w/w IPMP and 1426ppm fluoride as sodium fluoride.

Test zinc non- IPMP toothpasteother

Test toothpaste containing 0.6% w/w zinc chloride, 0% w/w IPMP and 1426ppm fluoride as sodium fluoride.

Positive controlother

Positive control toothpaste containing 0.454% w/w stannous fluoride (Fluoride Toothpaste (1100ppm Fluoride as stannous fluoride)).

SLS negative controlother

Negative control toothpaste containing 2.0% SLS, 0.65% Tegobetain and 1150 ppm fluoride as sodium fluoride

non-SLS negative controlother

Negative control toothpaste containing 1426 ppm fluoride as sodium fluoride