Clinical trial NCT03587428: Effect of Two Toothpastes on Bacteria in Saliva
Official title: In-house Study to Determine the Effect of Two Zinc-containing Toothpaste Formulations on Viability of Bacteria in Saliva
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Health
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2018-07-16
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: Change from baseline in log10-transformed AUC 0-2hr
Secondary outcomes:
measure: Change From Baseline in AUC (0-2) Hours for the Ratio of Live:Dead Bacteria Using Live-dead Staining Technique
timeFrame: Baseline up to 2 hours
measure: Change From Baseline in log10-transformed Total Viable Bacterial Count Using Traditional Bacterial Plating Technique
timeFrame: At Baseline, 5 minutes, 15 minutes, 30 minutes, 1 hour and 2 hours post-treatment
measure: Change From Baseline in Live:Dead Bacteria Ratio in Saliva Using Staining Technique
timeFrame: At Baseline, 30 minutes, 1 hour and 2 hours post-treatment
Other outcomes:
Locations:
city: Weybridge
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: