A Study to Investigate the Antimicrobial Activity of 2 Test Toothpastes
Status
Completed
Conditions
Dental Plaque
Treatments
Other: Test zinc non- IPMP toothpaste
Other: Test zinc-IPMP toothpaste
Other: SLS negative control
Other: Positive control
Other: non-SLS negative control
Details and patient eligibility
About
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).
Enrollment
45 patients
Sex
All
Ages
18+ years old
Volunteers
Accepts Healthy Volunteers
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.
Trial design
Primary purpose
Basic Science
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
Single Blind
45 participants in 5 patient groups
Test zinc-IPMP toothpaste
Experimental group
Description:
Rinse with preprepared slurry of toothpaste in 10 milliliter (mL) water for 60 seconds(s) followed by rinse with 10mL water
Treatment:
Other: Test zinc-IPMP toothpaste
Test zinc non- IPMP toothpaste
Experimental group
Description:
Rinse with preprepared slurry of toothpaste in 10 mL water for 60s followed by rinse with 10mL water
Treatment:
Other: Test zinc non- IPMP toothpaste
Positive control Toothpaste
Active Comparator group
Description:
Rinse with preprepared slurry of toothpaste in 10 mL water for 60s followed by rinse with 10mL water
Treatment:
Other: Positive control
SLS Negative Control
Active Comparator group
Description:
Rinse with preprepared slurry of toothpaste in 10 mL water for 60s followed by rinse with 10mL water
Treatment:
Other: SLS negative control
non-SLS negative control
Active Comparator group
Description:
Rinse with preprepared slurry of toothpaste in 10 mL water for 60s followed by rinse with 10mL water
Treatment:
Other: non-SLS negative control
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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