Oral HygienePhase 2NCT03267511
A Study to Investigate the Stain and Plaque Removal Capability of Two Experimental Potassium Nitrate Dentifrices
A Phase 2 study testing 5% KNO3 / 0.2542% NaF dentifrice with 0.5% spherical silica, 5% KNO3 / 0.2542% NaF dentifrice with 1% spherical silica and 5% STP and 5% KNO3 / 0.2542% NaF dentifrice with 6% abrasive silica in people with Oral Hygiene, run by GlaxoSmithKline at 1 site in United States.
Trial summary
The purpose of this study is to determine whether spherical silica can achieve similar or greater extrinsic dental stain and plaque removal, in comparison to dentifrices containing higher concentrations of standard abrasive silica, and how the addition of 5% sodium tripolyphosphate (STP) enhances cleaning capability. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Hygiene
- What is being tested?
- 5% KNO3 / 0.2542% NaF dentifrice with 0.5% spherical silica, 5% KNO3 / 0.2542% NaF dentifrice with 1% spherical silica and 5% STP and 5% KNO3 / 0.2542% NaF dentifrice with 6% abrasive silica
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2017to 2 Dec 2017
- Phase
- Phase 2
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
- Male and female participants who, at the time of screening, are between the ages of 18 and 65 years, inclusive.
- Participants who are willing and able to comply with scheduled visits, treatment plan, and other study procedures.
- Good general and mental health with, in the opinion of the investigator or medically qualified designee no clinically significant and relevant abnormalities of medical history or oral examination which could impact study outcomes.
- Good general and mental health with, in the opinion of the investigator or medically qualified designee an absence of any condition that would impact on participant safety or wellbeing, or affect the participant's ability to understand and follow study procedures and requirements.
- In the opinion of the investigator or medically qualified designee, at screening, participants must have good oral health.
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- In the opinion of the investigator or medically qualified designee, at screening, participants must have at least 20 natural teeth including the 12 anterior teeth, gradable for Turesky Plaque Index (TPI) (Gradable teeth are those where restorative materials cover less than 25% of the tooth surface to be graded).
- In the opinion of the investigator or medically qualified designee, at screening, participants must have the facial surfaces of at least 4 of the anterior teeth, gradable for the MLSI.
- In the opinion of the investigator or medically qualified designee, at screening, participants must have the presence of extrinsic dental stain (judged to be formed due to dietary factors) on the facial surfaces of the anterior teeth, as determined from a visual MLSI stain assessment.
- In the opinion of the investigator, at Visit 2, participants must have a sufficient level of extrinsic dental stain (in the opinion of the examiner) on the facial surfaces of the scorable anterior (maxillary and mandibular) teeth.
- At Visit 3, a minimum overall pre-brushing plaque score (TPI) of ≥2.0.
Who cannot join
- Participants who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or participants who are GSK employees directly involved in the conduct of the study.
- Participation in another clinical study or receipt of an investigational drug(s) within 30 days prior to study entry and/or during study participation.
- Participants who have previously been enrolled in this study.
- Acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
- Any condition which, in the opinion of the investigator, causes xerostomia.
- Pregnant female participants.
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- Breastfeeding female participants.
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- Unwilling or unable to comply with the lifestyle guidelines described in this protocol.
- Recent history (within the last year) of alcohol or other substance abuse.
- Participant is unwilling to abstain from tobacco or nicotine-containing product use (including E-cigarettes) during the treatment evaluation period.
- Participants using the following mouth rinses, or taking the medications listed below: a) Regular use of mouthwashes containing ingredients that are known to impart staining. For example, chlorhexidine, essential oils or cetylpyridinium chloride (CPC). b) Use of a chlorhexidine, essential oil or CPC containing mouthwash within 14 days of Visit 2 or throughout the study. c) Current use of Listerine, or any antimicrobial mouth rinse. d) Use of minocycline, tetracycline or doxycycline within 30 days prior to screening. e) Use of minocycline, tetracycline or doxycycline between the screening and baseline visits. f) Daily doses of a medication and/or traditional/herbal ingredients which, in the opinion of the investigator, may affect study outcomes. For example, drugs or supplements containing metal ions known to impart staining to the enamel.
- Participants who have the following dental exclusions: a) Received a dental prophylaxis within 8 weeks of screening. b) Gross periodontal disease, treatment of periodontal disease (including surgery) within 12 months of screening, scaling or root planning within 3 months of screening. c) Dental conditions / disease requiring immediate treatment. d) Used any professionally dispensed or over the counter bleaching/ whitening products (excluding daily use whitening dentifrices) within the past 3 months.
- Participants who have the following specific dental exclusions for assessment teeth: a) Any tooth which, in the opinion of the investigator, appears to be non-vital based on changes in the intrinsic colour. b) Tooth with evidence of current or recent caries, or reported treatment of decay in 12 months of screening. c) Tooth with exposed dentine which, in the opinion of the investigator, could impact grading of extrinsic dental stain; tooth with deep, defective or facial restorations; tooth used as an abutment for fixed or removable partial dentures; tooth with full crown or veneer, orthodontic bands or cracked enamel. d) Tooth with surface irregularities, discoloration due to trauma, tetracycline stain, restorations, or hypo or hyperplasic areas which, in the opinion of the investigator, would prevent consistent grading of extrinsic dental stain. e) High levels of calculus deposits which might interfere with plaque assessments at the discretion of the investigator. f) Presence of orthodontic bands or appliances, extensive crowns, partial dentures, or fixed retainers.
- Any participant who, in the judgment of the investigator, should not participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Examiner-blind, Proof of Principal Study to Investigate the Stain and Plaque Removal Capability of Two Experimental 5% Potassium Nitrate Dentifrices in Healthy Subjects With the Propensity for Extrinsic Dental Stain
The purpose of this study is to determine whether spherical silica can achieve similar or greater extrinsic dental stain and plaque removal, in comparison to dentifrices containing higher concentrations of standard abrasive silica, and how the addition of 5% sodium tripolyphosphate (STP) enhances cleaning capability.
Read the detailed description
This proof of principal (PoP) single centre, randomised, examiner blind, four-treatment arm, parallel design study will be conducted in healthy participants with a propensity for extrinsic dental stain (based on the judgement of the examiner) on the facial surfaces of the anterior teeth. This study will be used to evaluate and compare the extrinsic dental stain and plaque removal of an experimental low abrasivity 0.5% spherical silica dentifrice and a marketed low abrasivity 6% standard silica abrasive dentifrice, and an experimental moderate abrasivity 1% spherical silica / 5% STP dentifrice and a marketed high abrasivity 16% standard abrasive silica / 5% STP dentifrice. Stain will be assessed using an established clinical measure of extrinsic dental stain - the MacPherson modification of the Lobene stain index (MLSI). Particpants will be stratified by baseline MLSI score (total MLSI (area [A] × intensity [I]) for the facial surfaces of the 4 anterior assessment teeth). Plaque will be assessed using an established clinical measure of plaque - the Turesky Modification of the Quigley Hein Index. Stain and plaque will be assessed at intervals over an 8 week treatment period. Plaque will be assessed at baseline and Week 8 only.
- Conditions
- Oral Hygiene
- Being tested
- 5% KNO3 / 0.2542% NaF dentifrice with 0.5% spherical silica, 5% KNO3 / 0.2542% NaF dentifrice with 1% spherical silica and 5% STP, 5% KNO3 / 0.2542% NaF dentifrice with 6% abrasive silica, 5% KNO3 / 0.2543% NaF dentifrice with 16% abrasive silica and 5% STP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5% KNO3 / 0.2542% NaF dentifrice with 0.5% spherical silicaDrug
Participants will be instructed to apply a full brush head of their dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 0.5% spherical silica and brush twice daily (morning and evening) for one timed minute (in their usual manner).
5% KNO3 / 0.2542% NaF dentifrice with 1% spherical silica and 5% STPDrug
Participants will be instructed to apply a full brush head of their dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 1% spherical silica and 5% STP and brush twice daily (morning and evening) for one timed minute (in their usual manner).
5% KNO3 / 0.2542% NaF dentifrice with 6% abrasive silicaDrug
Participants will be instructed to apply a full brush head of their dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 6% abrasive silica and brush twice daily (morning and evening) for one timed minute (in their usual manner).
5% KNO3 / 0.2543% NaF dentifrice with 16% abrasive silica and 5% STPDrug
Participants will be instructed to apply a full brush head of their dentifrice containing 5% KNO3 / 0.2543% NaF dentifrice with 16% abrasive silica and 5% STP and brush twice daily (morning and evening) for one timed minute (in their usual manner).
| Study group | Role | What they receive |
|---|---|---|
| Test Product 1 | Experimental | Participants will be instructed to apply experimental dentifrice containing 5% potassium nitrate (KNO3) / 0.2542% sodium fluoride (NaF) dentifrice with 0.5% spherical silica. Receives: Drug: 5% KNO3 / 0.2542% NaF dentifrice with 0.5% spherical silica |
| Test Product 2 | Experimental | Participants will be instructed to apply experimental dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 1% spherical silica and 5% STP. Receives: Drug: 5% KNO3 / 0.2542% NaF dentifrice with 1% spherical silica and 5% STP |
| Reference Product 1 | Active comparator | Participants will be instructed to apply experimental dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 6% abrasive silica. Receives: Drug: 5% KNO3 / 0.2542% NaF dentifrice with 6% abrasive silica |
| Reference Product 2 | Active comparator | Participants will be instructed to apply experimental dentifrice containing 5% KNO3 / 0.2543% NaF dentifrice with 16% abrasive silica and 5% STP. Receives: Drug: 5% KNO3 / 0.2543% NaF dentifrice with 16% abrasive silica and 5% STP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Overall Macpherson Modification of the Lobene Stain Index (MLSI) at 8 Weeks.
An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI to evaluate ranking order in extrinsic dental stain removal or reduction of test product 1, test product 2, reference product 1, reference product 2; after usage for 8 weeks, twice daily brushing. The intensity of stain was scored separately for the gingival and body areas of each assessable tooth on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored separately for the gingival and body areas of each assessable tooth on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Overall MLSI was calculated by multiplying scores of intensity and area, and was thus analyzed on a scale of 0 (best score) to 9 (worst score).
Measured: Baseline, Week 8 post treatment administration
Secondary outcomes (2)
Difference of Least Square Mean of Change From Baseline in Overall MLSI After 8 Weeks (Test Product 1 Versus vs. Reference Product 1)
An assessment of the area and intensity of dental stain on the study teeth will be performed using the MLSI after usage test product 1 and reference product 1 for 8 weeks, twice daily brushing. The intensity of stain was scored separately for the gingival and body areas of each assessable tooth on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored separately for the gingival and body areas of each assessable tooth on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Overall MLSI will be calculated by multiplying scores of intensity and area, and will be thus analyzed on a scale of 0 (best score) to 9 (worst score).
Measured: Baseline, Week 8 post treatment administration
Difference of Least Square Mean of Change From Baseline in Overall MLSI After 8 Weeks (Test Product 2 Versus vs. Reference Product 2)
An assessment of the area and intensity of dental stain on the study teeth will be performed using the MLSI after usage test product 2 and reference product 2 for 8 weeks, twice daily brushing. The intensity of stain was scored separately for the gingival and body areas of each assessable tooth on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored separately for the gingival and body areas of each assessable tooth on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Overall MLSI will be calculated by multiplying scores of intensity and area, and will be thus analyzed on a scale of 0 (best score) to 9 (worst score).
Measured: Baseline, Week 8 post treatment administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start25 Sep 2017
- Primary completion2 Dec 2017
- Study completion2 Dec 2017
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 HygieneStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKlineGSK Clinical Trials, Study director, GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03267511
- Sponsor's protocol ID
- 208078
- Status last verified
- Jan 2019
- First submitted
- 28 Aug 2017
- Last updated
- 8 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Examiner-blind, Proof of Principal Study to Investigate the Stain and Plaque Removal Capability of Two Experimental 5% Potassium Nitrate Dentifrices in Healthy Subjects With the Propensity for Extrinsic Dental Stain
- ClinicalTrials.gov ID
- NCT03267511
- Acronym / sponsor ID
- 208078
- Conditions
- Oral Hygiene
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 25 Sep 2017 (actual)
- Primary completion
- 2 Dec 2017 (actual)
- Study completion
- 2 Dec 2017 (actual)
- First posted
- 30 Aug 2017 (actual)
- Results
- Posted 8 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether spherical silica can achieve similar or greater extrinsic dental stain and plaque removal, in comparison to dentifrices containing higher concentrations of standard abrasive silica, and how the addition of 5% sodium tripolyphosphate (STP) enhances cleaning capability.
Detailed description
This proof of principal (PoP) single centre, randomised, examiner blind, four-treatment arm, parallel design study will be conducted in healthy participants with a propensity for extrinsic dental stain (based on the judgement of the examiner) on the facial surfaces of the anterior teeth. This study will be used to evaluate and compare the extrinsic dental stain and plaque removal of an experimental low abrasivity 0.5% spherical silica dentifrice and a marketed low abrasivity 6% standard silica abrasive dentifrice, and an experimental moderate abrasivity 1% spherical silica / 5% STP dentifrice and a marketed high abrasivity 16% standard abrasive silica / 5% STP dentifrice. Stain will be assessed using an established clinical measure of extrinsic dental stain - the MacPherson modification of the Lobene stain index (MLSI). Particpants will be stratified by baseline MLSI score (total MLSI (area [A] × intensity [I]) for the facial surfaces of the 4 anterior assessment teeth). Plaque will be assessed using an established clinical measure of plaque - the Turesky Modification of the Quigley Hein Index. Stain and plaque will be assessed at intervals over an 8 week treatment period. Plaque will be assessed at baseline and Week 8 only.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Test Product 1 | Experimental | Drug: 5% KNO3 / 0.2542% NaF dentifrice with 0.5% spherical silicaParticipants will be instructed to apply experimental dentifrice containing 5% potassium nitrate (KNO3) / 0.2542% sodium fluoride (NaF) dentifrice with 0.5% spherical silica. |
| Test Product 2 | Experimental | Drug: 5% KNO3 / 0.2542% NaF dentifrice with 1% spherical silica and 5% STPParticipants will be instructed to apply experimental dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 1% spherical silica and 5% STP. |
| Reference Product 1 | Active comparator | Drug: 5% KNO3 / 0.2542% NaF dentifrice with 6% abrasive silicaParticipants will be instructed to apply experimental dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 6% abrasive silica. |
| Reference Product 2 | Active comparator | Drug: 5% KNO3 / 0.2543% NaF dentifrice with 16% abrasive silica and 5% STPParticipants will be instructed to apply experimental dentifrice containing 5% KNO3 / 0.2543% NaF dentifrice with 16% abrasive silica and 5% STP. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
- Male and female participants who, at the time of screening, are between the ages of 18 and 65 years, inclusive.
- Participants who are willing and able to comply with scheduled visits, treatment plan, and other study procedures.
- Good general and mental health with, in the opinion of the investigator or medically qualified designee no clinically significant and relevant abnormalities of medical history or oral examination which could impact study outcomes.
- Good general and mental health with, in the opinion of the investigator or medically qualified designee an absence of any condition that would impact on participant safety or wellbeing, or affect the participant's ability to understand and follow study procedures and requirements.
Key exclusion criteria (15 listed)
- Participants who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or participants who are GSK employees directly involved in the conduct of the study.
- Participation in another clinical study or receipt of an investigational drug(s) within 30 days prior to study entry and/or during study participation.
- Participants who have previously been enrolled in this study.
- Acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
- Any condition which, in the opinion of the investigator, causes xerostomia.
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 |
|---|---|---|
| 5% KNO3 / 0.2542% NaF dentifrice with 0.5% spherical silicaParticipants will be instructed to apply a full brush head of their dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 0.5% spherical silica and brush twice daily (morning and evening) for one timed minute (in their usual manner). | Drug | Test Product 1 |
| 5% KNO3 / 0.2542% NaF dentifrice with 1% spherical silica and 5% STPParticipants will be instructed to apply a full brush head of their dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 1% spherical silica and 5% STP and brush twice daily (morning and evening) for one timed minute (in their usual manner). | Drug | Test Product 2 |
| 5% KNO3 / 0.2542% NaF dentifrice with 6% abrasive silicaParticipants will be instructed to apply a full brush head of their dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 6% abrasive silica and brush twice daily (morning and evening) for one timed minute (in their usual manner). | Drug | Reference Product 1 |
| 5% KNO3 / 0.2543% NaF dentifrice with 16% abrasive silica and 5% STPParticipants will be instructed to apply a full brush head of their dentifrice containing 5% KNO3 / 0.2543% NaF dentifrice with 16% abrasive silica and 5% STP and brush twice daily (morning and evening) for one timed minute (in their usual manner). | Drug | Reference Product 2 |
Primary outcome
Change From Baseline in Overall Macpherson Modification of the Lobene Stain Index (MLSI) at 8 Weeks.
Time frame: Baseline, Week 8 post treatment administration
An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI to evaluate ranking order in extrinsic dental stain removal or reduction of test product 1, test product 2, reference product 1, reference product 2; after usage for 8 weeks, twice daily brushing. The intensity of stain was scored separately for the gingival and body areas of each assessable tooth on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored separately for the gingival and body areas of each assessable tooth on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Overall MLSI was calculated by multiplying scores of intensity and area, and was thus analyzed on a scale of 0 (best score) to 9 (worst score).
2 secondary outcomes
Difference of Least Square Mean of Change From Baseline in Overall MLSI After 8 Weeks (Test Product 1 Versus vs. Reference Product 1)
Time frame: Baseline, Week 8 post treatment administration
Difference of Least Square Mean of Change From Baseline in Overall MLSI After 8 Weeks (Test Product 2 Versus vs. Reference Product 2)
Time frame: Baseline, Week 8 post treatment administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 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
GSK Clinical Trials study director
GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 5% KNO3 / 0.2542% NaF dentifrice with 0.5% spherical silica, 5% KNO3 / 0.2542% NaF dentifrice with 1% spherical silica and 5% STP and 5% KNO3 / 0.2542% NaF dentifrice with 6% abrasive silica in people with Oral Hygiene, run by GlaxoSmithKline at 1 site in United States.
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 11 inclusion and 15 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 8 Jan 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 States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jan 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 Overall Macpherson Modification of the Lobene Stain Index (MLSI) at 8 Weeks. (time frame: Baseline, Week 8 post treatment administration). 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 8 Jan 2019.