Effect of Two Toothpastes on Bacteria in Saliva

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

NCT03587428

202287

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

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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