Effect of Two Toothpastes on Bacteria in Saliva

Not Applicable

Completed

• Conditions: Oral Health
• Interventions: Drug: Zinc-B toothpaste; Other: Mineral water; Drug: Zinc-A toothpaste

• Registration Number: NCT03587428
• Lead Sponsor: GlaxoSmithKline

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2014-11-04
• Primary Completion: 2014-11-27
• Study Completion: 2014-11-27
• Study First Submitted: 2018-07-03
• Study First Submitted QC: 2018-07-03
• Study First Posted: 2018-07-16
• Results First Submitted: 2018-10-15
• Status Verified: 2019-04
• Results First Submitted QC: 2019-04-30
• Last Update Submitted: 2019-04-30
• Results First Posted: 2019-07-15
• Last Update Posted: 2019-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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)

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Zinc-B toothpaste	Zinc-B toothpaste	In this arm, participants received Zinc-B toothpaste (test product 2) in the form of slurry.
Mineral Water	Mineral water	In this arm, participants received mineral water.
Zinc-A toothpaste	Zinc-A toothpaste	In this arm, participants received Zinc-A toothpaste (test product 1) in the form of slurry.

Primary Outcome Measures

Name	Time	Method
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	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

Name	Time	Method
Change From Baseline in AUC (0-2) Hours for the Ratio of Live:Dead Bacteria Using Live-dead Staining Technique	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.
Change From Baseline in Live:Dead Bacteria Ratio in Saliva Using Staining Technique	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.
Change From Baseline in log10-transformed Total Viable Bacterial Count Using Traditional Bacterial Plating Technique	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.

Trial Locations

Locations (1)

GSK Investigational Site; 🇬🇧 Weybridge, United Kingdom