Last updated: 09/30/2020 11:20:06

Effect of two toothpastes on bacteria in saliva

GSK study ID
202287
See study documents
Clinicaltrials.gov ID
NCT03587428
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: In-house study to determine the effect of two zinc-containing toothpaste formulations on viability of bacteria in saliva
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

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:

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

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

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

Interventions:
  • Drug: Zinc-A toothpaste
  • Drug: Zinc-B toothpaste
  • Other: Mineral water
    • Enrollment:
    15
    Primary completion date:
    2014-27-11
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Oral Health
    Product
    GI148564, GSK3413759, sodium fluoride
    Collaborators
    Not applicable
    Study date(s)
    November 2014 to November 2014
    Type
    Interventional
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 85 years
    Accepts healthy volunteers
    Yes
    • 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.
    • Study personnel: Members of the clinical study staff.
    • Pregnancy: Pregnant Women
    Inclusion and exclusion 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Weybridge, Weybridge, United Kingdom, KT13 0DE
    Status
    Study Complete
    Contact us

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)
    Statistical analysis plan
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2014-27-11
    Actual study completion date
    2014-27-11

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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