A Study to Investigate the Antimicrobial Activity of 2 Test Toothpastes

Study Overview
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Brief Summary
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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).

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

Conditions
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Dental Plaque

Intervention / Treatment
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* Other: Test zinc-IPMP toothpaste
* Other: Test zinc non- IPMP toothpaste
* Other: Positive control
* Other: SLS negative control
* Other: non-SLS negative control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test zinc-IPMP toothpaste<br>Rinse with preprepared slurry of toothpaste in 10 milliliter (mL) water for 60 seconds(s) followed by rinse with 10mL water | Other: Test zinc-IPMP toothpaste<br>* Test toothpaste containing 0.6% w/w zinc chloride and 0.1% w/w IPMP and 1426ppm fluoride as sodium fluoride.<br>|
| Experimental: Test zinc non- IPMP toothpaste<br>Rinse with preprepared slurry of toothpaste in 10 mL water for 60s followed by rinse with 10mL water | Other: Test zinc non- IPMP toothpaste<br>* Test toothpaste containing 0.6% w/w zinc chloride, 0% w/w IPMP and 1426ppm fluoride as sodium fluoride.<br>|
| Active Comparator: Positive control Toothpaste<br>Rinse with preprepared slurry of toothpaste in 10 mL water for 60s followed by rinse with 10mL water | Other: Positive control<br>* Positive control toothpaste containing 0.454% w/w stannous fluoride (Fluoride Toothpaste (1100ppm Fluoride as stannous fluoride)).<br>|
| Active Comparator: SLS Negative Control<br>Rinse with preprepared slurry of toothpaste in 10 mL water for 60s followed by rinse with 10mL water | Other: SLS negative control<br>* Negative control toothpaste containing 2.0% SLS, 0.65% Tegobetain and 1150 ppm fluoride as sodium fluoride<br>|
| Active Comparator: non-SLS negative control<br>Rinse with preprepared slurry of toothpaste in 10 mL water for 60s followed by rinse with 10mL water | Other: non-SLS negative control<br>* Negative control toothpaste containing 1426 ppm fluoride as sodium fluoride<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve for Glycolysis (AUCgly(0-90)) of Test Zinc-IPMP and Non-SLS Negative Control | AUCgly(0-90) of Test zinc-IPMP and non-SLS negative control was calculated using trapezoidal method. | Baseline up to 90 minutes (min) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCgly(0-90) for Test Zinc-IPMP, Test Zinc Non-IPMP, Positive Control, Non-SLS Negative Control and SLS Negative Control | AUCgly(0-90) for test zinc-IPMP, test zinc non-IPMP, positive control, non-SLS negative control and SLS negative control was calculated using trapezoidal method. | 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 | AUCregrowth(0-90) for test zinc-IPMP, test zinc non-IPMP, positive control, non-SLS negative control and SLS negative control was calculated using trapezoidal method. | 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 | AUClive:dead(0-90) for test zinc-IPMP, test zinc non-IPMP, positive control, non-SLS negative control and SLS negative control was calculated using trapezoidal method. | Baseline up to 90 min |