Oral HealthNCT03587428
Effect of Two Toothpastes on Bacteria in Saliva
A study testing Zinc-A toothpaste, Zinc-B toothpaste and Mineral water in people with Oral Health, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Health
- What is being tested?
- Zinc-A toothpaste, Zinc-B toothpaste and Mineral water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Nov 2014to 27 Nov 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: In-house Study to Determine the Effect of Two Zinc-containing Toothpaste Formulations on Viability of Bacteria in Saliva
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.
Read the 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
- Being tested
- Zinc-A toothpaste, Zinc-B toothpaste, Mineral water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc-A toothpasteDrug
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 toothpasteDrug
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 waterOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Zinc-A toothpaste | Experimental | In this arm, participants received Zinc-A toothpaste (test product 1) in the form of slurry. Receives: Drug: Zinc-A toothpaste |
| Zinc-B toothpaste | Experimental | In this arm, participants received Zinc-B toothpaste (test product 2) in the form of slurry. Receives: Drug: Zinc-B toothpaste |
| Mineral Water | Other | In this arm, participants received mineral water. Receives: Other: Mineral water |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Area Under the Curve (AUC) between 0 and 2 hours (hr) was assessed using traditional plating technique which provides the total viable counts (TVCs) of anaerobic bacteria. This outcome measure is AUC of change from baseline in log TVC. AUC for each time-point were calculated individually for each participant for each treatment and were aggregated into an AUC measurement. The aggregated AUC measurement was calculated in the order that first the collected data is logged which is further analyzed by change in log. Then, AUC 0-2hr change in log was calculated using the trapezoidal rule. The resulted values were then divided by 2hr to take out time units and are logged to calculate bacteria count. Hence, the outcome measure calculates change from baseline in log10-transformed AUC 0-2hr over the range from pre-treatment time point (0hr) to the concentration at 120 minutes (min) i.e., 2hr.
Measured: Change from baseline in log10-transformed AUC 0-2hr
Secondary outcomes (3)
Change From Baseline in AUC (0-2) Hours for the Ratio of Live:Dead Bacteria Using Live-dead Staining Technique
Anaerobic bacteria were counted using live:dead staining technique. Change from baseline in AUC (0-2)hr was calculated for the ratio of live and dead bacteria. Viable bacterial counts for each time-point were calculated individually for each participant for each treatment and were aggregated into an AUC measurement. AUC was calculated using the trapezoidal rule and using nominal time points. The resulted values were then divided by 2hr to take out time units. The AUC was calculated over the range from pre-treatment time point (0hr) to 2hr. In this outcome measure, the change from baseline is calculated in log ratio of live: dead.
Measured: Baseline up to 2 hours
Change From Baseline in log10-transformed Total Viable Bacterial Count Using Traditional Bacterial Plating Technique
Anaerobic bacteria were counted using traditional plating technique. Total viable bacterial counts for each time-point was calculated individually for each participant for each treatment. Change from baseline in log 10 transformed total viable bacterial values was calculated.
Measured: 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
Anaerobic bacteria were counted using live:dead staining technique. Change from baseline was calculated for the ratio of live to dead bacteria.
Measured: At Baseline, 30 minutes, 1 hour and 2 hours post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2018
- Study start4 Nov 2014
- Primary completion27 Nov 2014
- Study completion27 Nov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Oral HealthStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03587428
- Sponsor's protocol ID
- 202287
- Status last verified
- Apr 2019
- First submitted
- 3 Jul 2018
- Last updated
- 15 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-house Study to Determine the Effect of Two Zinc-containing Toothpaste Formulations on Viability of Bacteria in Saliva
- ClinicalTrials.gov ID
- NCT03587428
- Acronym / sponsor ID
- 202287
- Conditions
- Oral Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 4 Nov 2014 (actual)
- Primary completion
- 27 Nov 2014 (actual)
- Study completion
- 27 Nov 2014 (actual)
- First posted
- 16 Jul 2018 (actual)
- Results
- Posted 15 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Zinc-A toothpaste | Experimental | Drug: Zinc-A toothpasteIn this arm, participants received Zinc-A toothpaste (test product 1) in the form of slurry. |
| Zinc-B toothpaste | Experimental | Drug: Zinc-B toothpasteIn this arm, participants received Zinc-B toothpaste (test product 2) in the form of slurry. |
| Mineral Water | Other | Other: Mineral waterIn this arm, participants received mineral water. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zinc-A toothpasteParticipants 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. | Drug | Zinc-A toothpaste |
| Zinc-B toothpasteParticipants 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. | Drug | Zinc-B toothpaste |
| Mineral waterParticipants 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. | Other | Mineral Water |
Primary outcome
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
Time frame: Change from baseline in log10-transformed AUC 0-2hr
Area Under the Curve (AUC) between 0 and 2 hours (hr) was assessed using traditional plating technique which provides the total viable counts (TVCs) of anaerobic bacteria. This outcome measure is AUC of change from baseline in log TVC. AUC for each time-point were calculated individually for each participant for each treatment and were aggregated into an AUC measurement. The aggregated AUC measurement was calculated in the order that first the collected data is logged which is further analyzed by change in log. Then, AUC 0-2hr change in log was calculated using the trapezoidal rule. The resulted values were then divided by 2hr to take out time units and are logged to calculate bacteria count. Hence, the outcome measure calculates change from baseline in log10-transformed AUC 0-2hr over the range from pre-treatment time point (0hr) to the concentration at 120 minutes (min) i.e., 2hr.
3 secondary outcomes
Change From Baseline in AUC (0-2) Hours for the Ratio of Live:Dead Bacteria Using Live-dead Staining Technique
Time frame: Baseline up to 2 hours
Change From Baseline in log10-transformed Total Viable Bacterial Count Using Traditional Bacterial Plating Technique
Time frame: 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
Time frame: At Baseline, 30 minutes, 1 hour and 2 hours post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zinc-A toothpaste, Zinc-B toothpaste and Mineral water in people with Oral Health, run by GlaxoSmithKline at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Change from baseline in log10-transformed AUC 0-2hr). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2019.