Effect of Two Toothpastes on Bacteria in Saliva

NCT03587428 | Completed Results

• 1 other identifier: 202287
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Health

Outcome Measures

Primary Outcomes (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

  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.

  Change from baseline in log10-transformed AUC 0-2hr

Secondary Outcomes (3)

• 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

• 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

• Change From Baseline in Live:Dead Bacteria Ratio in Saliva Using Staining Technique

  At Baseline, 30 minutes, 1 hour and 2 hours post-treatment

Study Arms (3)

Zinc-A toothpaste

EXPERIMENTAL

In this arm, participants received Zinc-A toothpaste (test product 1) in the form of slurry.

Drug: Zinc-A toothpaste

Zinc-B toothpaste

EXPERIMENTAL

In this arm, participants received Zinc-B toothpaste (test product 2) in the form of slurry.

Drug: Zinc-B toothpaste

Mineral Water

OTHER

In this arm, participants received mineral water.

Other: Mineral water

Interventions

Zinc-A toothpaste DRUG

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.

Zinc-A toothpaste

Zinc-B toothpaste DRUG

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.

Zinc-B toothpaste

Mineral water OTHER

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.

Mineral Water

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Weybridge, KT13 0DE, United Kingdom

Location

MeSH Terms

Interventions

Mineral Waters

Intervention Hierarchy (Ancestors)

Water; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2018
• First Posted: July 16, 2018
• Study Start: November 4, 2014
• Primary Completion: November 27, 2014
• Study Completion: November 27, 2014
• Last Updated: July 15, 2019
• Results First Posted: July 15, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)