GingivitisPhase 1NCT01079910
To Investigate the Clinical Efficacy of an Experimental Toothpaste
A Phase 1 study testing isopropylmethylphenol and Fluoride and Fluoride and Silica in people with Gingivitis, run by GlaxoSmithKline.
Trial summary
The objective of this study is to evaluate the effect of an experimental toothpaste on maintaining gingival health over a 24 week period measured through modified gingival index, bleeding, plaque, and plaque bacteria. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingivitis
- What is being tested?
- isopropylmethylphenol and Fluoride and Fluoride and Silica
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 9 Dec 2009to 10 Dec 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects aged 18 years and older
- A minimum of 20 permanent gradable teeth
- For baseline eligibility, subjects must have a minimum Modified Gingival Index score of 1.5-2.3.
Who cannot join
None listed.
About this study
Official title: Clinical Efficacy of an Experimental Toothpaste
The objective of this study is to evaluate the effect of an experimental toothpaste on maintaining gingival health over a 24 week period measured through modified gingival index, bleeding, plaque, and plaque bacteria. Prior to commencing study treatment, subjects will undergo a dental prophylaxis followed by a 2 week period of oral hygiene instruction and weekly professional tooth cleaning to bring the subjects to their optimum gingival health prior to commencing study treatment.
- Conditions
- Gingivitis
- Being tested
- isopropylmethylphenol and Fluoride, Fluoride and Silica
- Keywords
- Plaque, Toothpaste, Gingivitis
- Medical subject headings
- Gingivitis, Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
isopropylmethylphenol and FluorideDrug
0.1% isopropylmethylphenol and 1150ppm fluoride
Fluoride and SilicaDrug
NaF/Silica toothpaste containing 1150ppm fluoride
| Study group | Role | What they receive |
|---|---|---|
| Experimental toothpaste | Experimental | 0.1% isopropylmethylphenol and 1150ppm fluoride Receives: Drug: isopropylmethylphenol and Fluoride |
| Marketed toothpaste | Other | NaF/Silica toothpaste containing 1150ppm fluoride Receives: Drug: Fluoride and Silica |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Modified Gingival Index at 24 weeks
Measured: baseline to 24 weeks
Change from baseline Bleeding Index at 24 weeks
Measured: baseline to 24 weeks
Secondary outcomes (4)
Change from baseline Modified Gingival Index at weeks 6 & 12
Measured: baseline to week 12
Change from baseline Bleeding Index at weeks 6 & 12
Measured: baseline to week 12
Change from baseline Plaque Index at weeks 6, 12 & 24
Measured: baseline to week 24
Change from baseline plaque bacteria at weeks 12 & 24
Measured: baseline to week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2010 (estimated)
- Study start9 Dec 2009 (estimated)
- Primary completion10 Dec 2009 (estimated)
- Study completion10 Dec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 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
- NCT01079910
- Sponsor's protocol ID
- T3450803
- Status last verified
- Jul 2018
- First submitted
- 18 Feb 2010
- Last updated
- 16 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of an Experimental Toothpaste
- ClinicalTrials.gov ID
- NCT01079910
- Acronym / sponsor ID
- T3450803
- Conditions
- Gingivitis
- Keywords
- Plaque, Toothpaste, Gingivitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 9 Dec 2009 (estimated)
- Primary completion
- 10 Dec 2009 (estimated)
- Study completion
- 10 Dec 2009 (estimated)
- First posted
- 3 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the effect of an experimental toothpaste on maintaining gingival health over a 24 week period measured through modified gingival index, bleeding, plaque, and plaque bacteria. Prior to commencing study treatment, subjects will undergo a dental prophylaxis followed by a 2 week period of oral hygiene instruction and weekly professional tooth cleaning to bring the subjects to their optimum gingival health prior to commencing study treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental toothpaste | Experimental | Drug: isopropylmethylphenol and Fluoride0.1% isopropylmethylphenol and 1150ppm fluoride |
| Marketed toothpaste | Other | Drug: Fluoride and SilicaNaF/Silica toothpaste containing 1150ppm fluoride |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy subjects aged 18 years and older
- A minimum of 20 permanent gradable teeth
- For baseline eligibility, subjects must have a minimum Modified Gingival Index score of 1.5-2.3.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| isopropylmethylphenol and Fluoride0.1% isopropylmethylphenol and 1150ppm fluoride | Drug | Experimental toothpaste |
| Fluoride and SilicaNaF/Silica toothpaste containing 1150ppm fluoride | Drug | Marketed toothpaste |
Primary outcome
Change from baseline Modified Gingival Index at 24 weeks
Time frame: baseline to 24 weeks
Change from baseline Bleeding Index at 24 weeks
Time frame: baseline to 24 weeks
4 secondary outcomes
Change from baseline Modified Gingival Index at weeks 6 & 12
Time frame: baseline to week 12
Change from baseline Bleeding Index at weeks 6 & 12
Time frame: baseline to week 12
Change from baseline Plaque Index at weeks 6, 12 & 24
Time frame: baseline to week 24
Change from baseline plaque bacteria at weeks 12 & 24
Time frame: baseline to week 24
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2018.
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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
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing isopropylmethylphenol and Fluoride and Fluoride and Silica in people with Gingivitis, run by GlaxoSmithKline.
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 3 inclusion and 0 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: withdrawn, as of the sponsor's last update on 16 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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 Modified Gingival Index at 24 weeks (time frame: baseline to 24 weeks). The study lists 2 primary outcomes in all. 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 16 Jul 2018.