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Effect of Two Toothpastes on Bacteria in Saliva

GlaxoSmithKline (GSK) logo

GlaxoSmithKline (GSK)

Status

Completed

Conditions

Oral Health

Treatments

Other: Mineral water
Drug: Zinc-B toothpaste
Drug: Zinc-A toothpaste

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 patients

Sex

All

Ages

18 to 85 years old

Volunteers

Accepts Healthy Volunteers

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 design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

15 participants in 3 patient groups

Zinc-A toothpaste
Experimental group
Description:
In this arm, participants received Zinc-A toothpaste (test product 1) in the form of slurry.
Treatment:
Drug: Zinc-A toothpaste
Zinc-B toothpaste
Experimental group
Description:
In this arm, participants received Zinc-B toothpaste (test product 2) in the form of slurry.
Treatment:
Drug: Zinc-B toothpaste
Mineral Water
Other group
Description:
In this arm, participants received mineral water.
Treatment:
Other: Mineral water

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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