Effect of Two Toothpastes on Bacteria in Saliva

NCT ID: NCT03587428

Last Updated: 2019-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-04
• Study Completion Date: 2014-11-27

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.

Conditions

Oral Health

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Zinc-A toothpaste

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

Group Type: EXPERIMENTAL

Zinc-A toothpaste

Intervention Type: 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-B toothpaste

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

Group Type: EXPERIMENTAL

Zinc-B toothpaste

Intervention Type: 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.

Mineral Water

In this arm, participants received mineral water.

Group Type: OTHER

Mineral water

Intervention Type: 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.

Interventions

Zinc-A toothpaste

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.

Intervention Type: DRUG

Zinc-B toothpaste

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.

Intervention Type: DRUG

Mineral water

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.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Weybridge, , United Kingdom

Countries

United Kingdom

Other Identifiers

202287

Identifier Type: -

Identifier Source: org_study_id