Last updated: 11/03/2018 23:05:50
A Study to Investigate the Antimicrobial Activity of 2 Test Toothpastes
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Study to Investigate the Antimicrobial Activity of two Test Toothpastes in a Plaque Glycolysis and Regrowth Model
Trial description: 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 plaquebacteria using the plaque glycolysis regrowth model (PGRM).
Primary purpose:
Basic Science
Trial design:
Crossover Assignment
Masking:
Single (Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Area under the curve for glycolysis (AUCgly(0-90)) of Test zinc-IPMP and non-SLS negative control
Timeframe: Baseline up to 90 minutes (min)
Secondary outcomes:
AUCgly(0-90) for test zinc-IPMP, test zinc non-IPMP, positive control, non-SLS negative control and SLS negative control
Timeframe: Baseline up to 90 min
AUCregrowth(0-90) for test zinc-IPMP, test zinc non-IPMP, positive control, non-SLS negative control and SLS negative control
Timeframe: Baseline up to 90 min
AUClive:dead(0-90) for test zinc-IPMP, test zinc non-IPMP, positive control, non-SLS negative control and SLS negative control
Timeframe: Baseline up to 90 min
Interventions:
Other: Test zinc-IPMP toothpaste
Other: Test zinc non- IPMP toothpaste
Other: Positive control
Other: SLS negative control
Other: non-SLS negative control
Enrollment:
45
Observational study model:
Not applicable
Primary completion date:
2015-11-12
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Dental Plaque
Product
SKF46655, sodium fluoride
Collaborators
Not applicable
Study date(s)
November 2015 to December 2015
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Yes
- 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.
- 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.
Inclusion and exclusion 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.
Trial location(s)
Study documents
Statistical analysis plan
Available language(s): English
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2015-11-12
Actual study completion date
2015-11-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website