N/A
N=45
A Study to Investigate the Antimicrobial Activity of 2 Test Toothpastes
Dental Plaque
Bottom Line
View on ClinicalTrials.gov: NCT02856880 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Area Under the Curve for Glycolysis (AUCgly(0-90)) of Test Zinc-IPMP and Non-SLS Negative Control — 42.64; 2.46 plaque incubation pH*min — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Test zinc-IPMP toothpaste (Other); Test zinc non- IPMP toothpaste (Other); Positive control (Other); SLS negative control (Other); non-SLS negative control (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve for Glycolysis (AUCgly(0-90)) of Test Zinc-IPMP and Non-SLS Negative Control |
42.64; 2.46 | <0.0001 sig |
| SECONDARY AUCgly(0-90) for Test Zinc-IPMP, Test Zinc Non-IPMP, Positive Control, Non-SLS Negative Control and SLS Negative Control |
42.64; 34.20; 28.88; 2.46; 31.78 | <0.0001 sig |
| SECONDARY AUCregrowth(0-90) for Test Zinc-IPMP, Test Zinc Non-IPMP, Positive Control, Non-SLS Negative Control and SLS Negative Control |
-239.81; -240.86; -179.55; 53.66; -215.08 | <0.0001 sig |
| SECONDARY AUClive:Dead(0-90) for Test Zinc-IPMP, Test Zinc Non-IPMP, Positive Control, Non-SLS Negative Control and SLS Negative Control |
75.23; -691.41; 72.19; 346.11; -601.87 | 0.6664 |
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).
Eligibility Criteria
Inclusion Criteria
- Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- Good general and mental health with, in the opinion of the investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history or upon oral examination.
- Plaque sample acidogenicity in the pH range 5.0 to 5.7 at Visit.
Exclusion Criteria
- Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
- Women who are breast-feeding.
- Currently taking antibiotics or have taken antibiotics within 2 weeks of plaque assessment (Visit 2). A participant with any medical history that may prevent them from participating in the study until study conclusion (such as diabetes).
- Any sign of grossly carious lesions (active), moderate or severe periodontal conditions, or severe tooth wear.
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- Current smokers, or smokers who have quit within 6 months of screening, or participants currently using smokeless forms of tobacco, e.g. Gutkha, Pan containing tobacco, Pan Masala.
- Current active caries or periodontitis that may compromise, in the opinion of the investigator, study outcomes or the health of the subject.
- Restorations in a poor state of repair that may, in the opinion of the investigator, compromise study outcomes or the health of the participant.
- Partial dentures or orthodontic appliances that may, in the opinion of the investigator, compromise study outcomes or the health of the participant.
- Recent history (within the last year) of alcohol or other substance abuse.
Data sourced from ClinicalTrials.gov (NCT02856880). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.