Effect of Two Toothpastes on Bacteria in Saliva

• ClinicalTrials.gov Identifier: NCT03587428
• Recruitment Status: Completed
• First Posted: July 16, 2018
• Results First Posted: July 15, 2019
• Last Update Posted: July 15, 2019
• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

Study Description

Brief Summary:

This study investigated the ability of two zinc-containing toothpaste formulations (Zinc A and Zinc B) to reduce the level of bacteria in saliva in the two-hour period after their use, compared to the effect of rinsing with water alone.

Condition or disease	Intervention/treatment	Phase
Oral Health	Drug: Zinc-A toothpaste; Drug: Zinc-B toothpaste; Other: Mineral water	Not Applicable

Detailed Description:

This was a single centre, three treatment, randomized, blinded, cross-over study which involved rinsing with slurries of two sodium fluoride-silica dentifrices containing zinc chloride and sodium citrate, and with water alone. The study consisted of four Visits: Visit 1 (Screening), Visit 2 (Treatment 1), Visit 3 (Treatment 2), Visit 4 (Treatment 3). There was a minimum two days wash out period before the first treatment visit and between treatment visits to avoid any treatment carry-over effect. During that time participants brushed as normal (twice-daily) at home with a washout toothpaste and a toothbrush which was provided at screening. Participants were required not to brush their teeth on the morning of the treatment visits and not to eat or drink for 2 hours prior to the treatment visits.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: In-house Study to Determine the Effect of Two Zinc-containing Toothpaste Formulations on Viability of Bacteria in Saliva
• Actual Study Start Date: November 4, 2014
• Actual Primary Completion Date: November 27, 2014
• Actual Study Completion Date: November 27, 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: Zinc-A toothpaste; In this arm, participants received Zinc-A toothpaste (test product 1) in the form of slurry.	Drug: Zinc-A toothpaste; Participants received 6.0 grams (g) [± 0.3g] of the Zinc-A toothpaste in the form of slurry, one day per treatment (with at least 2 [generally 7] days between treatments. Participants emptied the contents of the dosing cup into their mouth, swilled the product around their mouth for 2 timed minutes then they expectorated into a sink.
Experimental: Zinc-B toothpaste; In this arm, participants received Zinc-B toothpaste (test product 2) in the form of slurry.	Drug: Zinc-B toothpaste; Participants received 6.0 grams (g) [± 0.3g] of the Zinc-B toothpaste in the form of slurry, one day per treatment (with at least 2 [generally 7] days between treatments. Participants emptied the contents of the dosing cup into their mouth, swilled the product around their mouth for 2 timed minutes then they expectorated into a sink.
Mineral Water; In this arm, participants received mineral water.	Other: Mineral water; Participants received 6.0g (±0.3g) of mineral water (by weighing out), one day per treatment (with at least 2 [generally 7] days between treatments). Participants emptied the contents of the dosing cup into their mouth, swilled the product around their mouth for 2 timed minutes then they expectorated into a sink.

Outcome Measures

Primary Outcome Measures :

1. Change From Baseline in Area Under the Curve Between 0 and 2 Hours (AUC [0-2] Hours) for Total Viable Counts (TVCs) of Bacteria in Saliva Using Traditional Plating Technique [ Time Frame: Change from baseline in log10-transformed AUC 0-2hr ]
   Area Under the Curve (AUC) between 0 and 2 hours (hr) was assessed using traditional plating technique which provides the total viable counts (TVCs) of anaerobic bacteria. This outcome measure is AUC of change from baseline in log TVC. AUC for each time-point were calculated individually for each participant for each treatment and were aggregated into an AUC measurement. The aggregated AUC measurement was calculated in the order that first the collected data is logged which is further analyzed by change in log. Then, AUC 0-2hr change in log was calculated using the trapezoidal rule. The resulted values were then divided by 2hr to take out time units and are logged to calculate bacteria count. Hence, the outcome measure calculates change from baseline in log10-transformed AUC 0-2hr over the range from pre-treatment time point (0hr) to the concentration at 120 minutes (min) i.e., 2hr.

Secondary Outcome Measures :

1. Change From Baseline in AUC (0-2) Hours for the Ratio of Live:Dead Bacteria Using Live-dead Staining Technique [ Time Frame: Baseline up to 2 hours ]
   Anaerobic bacteria were counted using live:dead staining technique. Change from baseline in AUC (0-2)hr was calculated for the ratio of live and dead bacteria. Viable bacterial counts for each time-point were calculated individually for each participant for each treatment and were aggregated into an AUC measurement. AUC was calculated using the trapezoidal rule and using nominal time points. The resulted values were then divided by 2hr to take out time units. The AUC was calculated over the range from pre-treatment time point (0hr) to 2hr. In this outcome measure, the change from baseline is calculated in log ratio of live: dead.
2. Change From Baseline in log10-transformed Total Viable Bacterial Count Using Traditional Bacterial Plating Technique [ Time Frame: At Baseline, 5 minutes, 15 minutes, 30 minutes, 1 hour and 2 hours post-treatment ]
   Anaerobic bacteria were counted using traditional plating technique. Total viable bacterial counts for each time-point was calculated individually for each participant for each treatment. Change from baseline in log 10 transformed total viable bacterial values was calculated.
3. Change From Baseline in Live:Dead Bacteria Ratio in Saliva Using Staining Technique [ Time Frame: At Baseline, 30 minutes, 1 hour and 2 hours post-treatment ]
   Anaerobic bacteria were counted using live:dead staining technique. Change from baseline was calculated for the ratio of live to dead bacteria.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Personnel: GSKCH permanent and contract/contingency workers.
• Consent: Demonstrated understanding of the study and was willing to participate and had received a signed and dated copy of the informed consent form.
• Compliance: Understood, was willing and able and complied with all study procedures and restrictions.
• General Health: Good general health
• Oral Health: Good oral health
• Salivary Flow Rate: Had a salivary flow rate in the range of normal values (unstimulated whole saliva flow rate ≥ 0.2milliliter per minute (ml/min); stimulated whole saliva flow rate ≥ 0.8ml/min)

Exclusion Criteria:

• Study personnel: Members of the clinical study staff.
• Pregnancy: Pregnant Women
• Breast-feeding: Women who were breast-feeding.
• Allergy/Intolerance: Had Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
• Medication: a) Used an antimicrobial mouthwash within 48 hours of the test visit e.g. Listerine, Corsodyl etc. b) had taken, antibiotics within 2 weeks of the test visit.
• Oral Surgery and Dental Conditions: a)Had an on-going dental treatment b) Had any oral surgery or extraction within 6 weeks of screening c) Symptoms of oral pain or any self-reported oral ulcers or herpetic lesions
• Clinical Study Participation: a) Participation in a clinical study where they received an investigational drug within 2 weeks of the screening visit b) Previously participated in this study.
• Substance Abstinence: Participant who were unwilling to abstain from smoking for at least 2 hours prior to treatment visits.

Contacts and Locations

Locations

United Kingdom

GSK Investigational Site

Weybridge, United Kingdom, KT13 0DE

Sponsors and Collaborators

GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline

More Information

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT03587428
• Other Study ID Numbers: 202287
• First Posted: July 16, 2018
• Results First Posted: July 15, 2019
• Last Update Posted: July 15, 2019
• Last Verified: April 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Zinc; Trace Elements; Micronutrients; Physiological Effects of Drugs