N/A
N=15
Effect of Two Toothpastes on Bacteria in Saliva
Oral Health
Bottom Line
View on ClinicalTrials.gov: NCT03587428 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: 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 — 8.818; 8.785; 8.845; -0.037 Log10 (cells/ml) — p=0.1787
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Zinc-A toothpaste (Drug); Zinc-B toothpaste (Drug); Mineral water (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Nov 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
8.818; 8.785; 8.845; -0.037; -0.348; 0.193 | 0.1787 |
| SECONDARY Change From Baseline in AUC (0-2) Hours for the Ratio of Live:Dead Bacteria Using Live-dead Staining Technique |
0.758; 0.946; 0.906; -7.612; -10.927; -1.024 | — |
| SECONDARY Change From Baseline in log10-transformed Total Viable Bacterial Count Using Traditional Bacterial Plating Technique |
-0.364; -0.474; 0.144; -0.030; -0.214; 0.161 | — |
| SECONDARY Change From Baseline in Live:Dead Bacteria Ratio in Saliva Using Staining Technique |
-4.701; -6.728; -0.049; -4.259; -6.153; -0.820 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT03587428). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.