Last updated: 09/30/2020 11:20:06
Effect of two toothpastes on bacteria in saliva
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2014-27-11
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
GSK Investigational Site
Weybridge, Weybridge, United Kingdom, KT13 0DE
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
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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