Dental PlaqueNCT03285984
Ability of Four Toothpastes to Remove Plaque
A study testing 67% Sodium Bicarbonate with 6 herbs plus 923parts per million (ppm) Sodium Fluoride, 67% Sodium Bicarbonate without herbs plus 923 ppm Sodium Fluoride and 62% Sodium Bicarbonate with 6 herbs and 5% w/w silica plus 923 ppm Sodium in people with Dental Plaque, run by GlaxoSmithKline.
Trial summary
The aim of this study is to evaluate and compare the plaque removal efficacy of four experimental toothpastes following a single timed brushing. Prior to each treatment visit, participants will abstain from oral hygiene for a period of 24 hours (+6hrs, -2hrs), immediately preceding a pre-brushing dental plaque… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque
- What is being tested?
- 67% Sodium Bicarbonate with 6 herbs plus 923parts per million (ppm) Sodium Fluoride, 67% Sodium Bicarbonate without herbs plus 923 ppm Sodium Fluoride and 62% Sodium Bicarbonate with 6 herbs and 5% w/w silica plus 923 ppm Sodium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 27 Mar 2012to 8 May 2012
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- Aged at least 18 years
- Understands and is willing, able and likely to comply with all study procedures and restrictions
- Good general health with (in the opinion of the Investigator) no clinically significant and relevant abnormalities of medical history or dental history.
- Good dental health based on medical history and oral soft tissue examination at screening
- At least 20 gradable, natural, uncrowned teeth with both facial and lingual scoreable surfaces (gradable teeth are those where restorative materials cover less than 25% of the tooth surface graded)
- Plaque Score: Mean Turesky plaque score of ≥ 2.00 at treatment visit 1 pre-brushing plaque assessment
Who cannot join
- Women who are known to be pregnant or who are intending to become pregnant over the duration of the study
- Women who are breast-feeding
- Antibiotic treatment within 14 days prior to Treatment Visit 1 or throughout the study
- Any other treatment that would interfere with the study results/conduct, at the discretion of the examiner or investigator
- Diabetes mellitus type I or II
- Any disease systemic or localized, dental or non dental, which could put the participant's health at risk or interfere with the study results/conduct, at the discretion of the examiner or investigator
Show all 25Show fewer
- High levels of extrinsic stain or calculus deposits which might interfere with plaque assessments
- Dental condition/ disease requiring immediate treatment
- Pre-existing sensitivity to oral care products
- Severe gingivitis
- Periodontitis with pocket depth > 5mm affecting more than two teeth
- Moderate or severe recession
- Presence of orthodontic bands or appliances, extensive crowns, partial dentures, or fixed retainers on the maxillary or mandibular teeth
- Obvious active carious lesions needing immediate care
- Intra-oral decorative tattoos, or tongue and or lip piercing
- Oral lesions/manifestations that would impact on the outcome of the study
- Presence of oral or peri-oral ulceration including herpetic lesions at the time of screening or at baseline
- Known or suspected intolerance or hypersensitivity to the studymaterials (or closely related compounds) or any of their stated ingredients
- Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit
- Previous participation in this study
- Recent history (within the last year) of alcohol or other substance abuse
- Current use of Listerine or any antimicrobial mouth rinse containing Chlorhexidine or Cetrylpyridinium Chloride (CPC)
- Participant unwilling to abstain from using chewing tobacco (with or without tobacco)
- Participant unwilling to abstain from smoking on the morning prior to treatment visits
- An employee of the sponsor or the study site or members of their immediate family
About this study
Official title: Plaque Removal Efficacy of Four Dentifrices in a Single Brushing Model
The aim of this study is to evaluate and compare the plaque removal efficacy of four experimental toothpastes following a single timed brushing. Prior to each treatment visit, participants will abstain from oral hygiene for a period of 24 hours (+6hrs, -2hrs), immediately preceding a pre-brushing dental plaque evaluation. Participants will then brush once under supervision for one timed minute with each dentifrice after which re-disclosing and a post-brushing plaque assessment will be carried out.
Read the detailed description
This study will be a single centre, randomized, controlled, examiner blind, four treatment, four period crossover design. At the screening visit, following provision of written informed consent, eligible participants will be provided with a washout toothpaste and toothbrush for use at home during the study and for at least 14 days prior to the first treatment visit.
Participants will then be scheduled to attend the first of four treatment visits a minimum of 14 days later. For each treatment visit, participants must abstain from oral hygiene for a period of 24 hours (+6hrs, -2hrs), immediately preceding the pre-brushing dental plaque evaluation. All the participants will undergo an oral soft tissue (OST) examination followed by disclosing and a dental plaque assessment.
At the treatment visit 1 pre-brushing plaque assessment, those who develop a sufficient amount of plaque (Turesky mean score ≥ 2.00) will be randomized to study treatment. Participants will then brush once (1.5 grams [g] ± 0.05g of assigned toothpaste), under supervision of study staff for one timed minute, with one of the four test toothpastes after which re-disclosing and a post-brushing plaque assessment will be carried out. Participants will be allowed to brush with the washout paste following the post assessment plaque assessments.
A minimum of three days washout period will follow each treatment period during which period Participants will brush with a commercial washout toothpaste. Participants will complete four treatment visits and will brush once with each of the four test toothpastes throughout the course of the study.
- Conditions
- Dental Plaque
- Being tested
- 67% Sodium Bicarbonate with 6 herbs plus 923parts per million (ppm) Sodium Fluoride, 67% Sodium Bicarbonate without herbs plus 923 ppm Sodium Fluoride, 62% Sodium Bicarbonate with 6 herbs and 5% w/w silica plus 923 ppm Sodium, 0% Sodium Bicarbonate without herbs plus 923ppm Sodium Fluoride
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
67% Sodium Bicarbonate with 6 herbs plus 923parts per million (ppm) Sodium FluorideOther
Toothpaste containing 67 percent (%) Sodium Bicarbonate with 6 herbs plus 923parts per million (ppm) Sodium Fluoride
67% Sodium Bicarbonate without herbs plus 923 ppm Sodium FluorideOther
Toothpaste containing 67% Sodium Bicarbonate without herbs plus 923 ppm Sodium Fluoride
62% Sodium Bicarbonate with 6 herbs and 5% w/w silica plus 923 ppm SodiumOther
Whitening Toothpaste containing 62% Sodium Bicarbonate with 6 herbs and 5% w/w silica plus 923 ppm Sodium
0% Sodium Bicarbonate without herbs plus 923ppm Sodium FluorideOther
Toothpaste containing 0% Sodium Bicarbonate without herbs plus 923ppm Sodium Fluoride
| Study group | Role | What they receive |
|---|---|---|
| Test product 1 | Experimental | Participants will brush once (1.5g ± 0.05g of Test product 1), under supervision of study staff for one timed minute Receives: Other: 67% Sodium Bicarbonate with 6 herbs plus 923parts per million (ppm) Sodium Fluoride |
| Test product 2 | Experimental | Participants will brush once (1.5g ± 0.05g of Test product 2), under supervision of study staff for one timed minute Receives: Other: 67% Sodium Bicarbonate without herbs plus 923 ppm Sodium Fluoride |
| Test product 3 | Experimental | Participants will brush once (1.5g ± 0.05g of Test product 3), under supervision of study staff for one timed minute Receives: Other: 62% Sodium Bicarbonate with 6 herbs and 5% w/w silica plus 923 ppm Sodium |
| Test product 4 | Experimental | Participants will brush once (1.5g ± 0.05g of Test product 4), under supervision of study staff for one timed minute Receives: Other: 0% Sodium Bicarbonate without herbs plus 923ppm Sodium Fluoride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline (Pre-brushing to Post-brushing) in Turesky Score After Single Supervised Use (Test Product 1 Versus [vs] Test Product 4) After 4 Weeks
The dental examiner used Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth.Overall plaque scores were calculated taking average over all tooth sites for participant.Plaque was first disclosed using dye solution followed by disclosing solution.They expectorated and rinsed with 10 milliliters (mL) water for 10 seconds (sec),expectorated again. Plaque was assessed with each tooth being divided into 6 areas including mesiofacial,facial,distofacial,mesiolingual,lingual,distolingual surfaces.Disclosed plaque was scored for each tooth surface separately as:0 No plaque;1 Slight flecks of plaque at cervical margin of the tooth;2 A thin continuous band of plaque(1 mm or smaller) at cervical margin of tooth;3 A band of plaque wider than 1 mm but covering less than 1/3 of the crown of tooth;4 Plaque covering at least 1/3 but less than 2/3 of crown of tooth;5 Plaque covering 2/3 or more of crown of tooth.Score range 0-5.Lower scores indicate less plaque area.
Measured: Baseline to 4 Weeks
Secondary outcomes (1)
Mean Change From Baseline (Pre-brushing to Post Brushing) in Turesky Score After Single Supervised Use for Test Products 1, 2, 3 and 4 After 4 Weeks
The dental examiner used Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth.Overall plaque scores were calculated taking average over all tooth sites for participant.Plaque was first disclosed using dye solution followed by disclosing solution.They expectorated and rinsed with 10 mL of water for 10 sec,expectorated again. Plaque was assessed with each tooth being divided into 6 areas including mesiofacial,facial,distofacial,mesiolingual,lingual,distolingual surfaces.Disclosed plaque was scored for each tooth surface separately as:0 No plaque;1 Slight flecks of plaque at cervical margin of the tooth;2 A thin continuous band of plaque(1 mm or smaller) at cervical margin of tooth;3 A band of plaque wider than 1 mm but covering less than 1/3 of the crown of tooth;4 Plaque covering at least 1/3 but less than 2/3 of crown of tooth;5 Plaque covering 2/3 or more of crown of tooth.Score range 0-5.Lower scores indicate less plaque area.
Measured: Baseline to 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study start27 Mar 2012
- Primary completion8 May 2012
- Study completion8 May 2012
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental PlaqueStudies 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
- Model description
- The randomization schedule will indicate the treatment order sequence. Each subject will complete all four treatment regimens, one treatment regimen in each of the four treatment periods. This randomization will use a Williams Square layout and be provided by the Biostatistics Department, GSKCH.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 56 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
- NCT03285984
- Sponsor's protocol ID
- 202655
- Status last verified
- Oct 2018
- First submitted
- 12 Sep 2017
- Last updated
- 16 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bosma ML, Milleman KR, Akwagyiram I, Targett D, Milleman JL. A randomised controlled trial to evaluate the plaque removal efficacy of sodium bicarbonate dentifrices in a single brushing clinical model. BDJ Open. 2018 Jun 4;4:17037. doi: 10.1038/s41405-018-0003-7. eCollection 2018.
PubMed 29971158
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plaque Removal Efficacy of Four Dentifrices in a Single Brushing Model
- ClinicalTrials.gov ID
- NCT03285984
- Acronym / sponsor ID
- 202655
- Conditions
- Dental Plaque
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 27 Mar 2012 (actual)
- Primary completion
- 8 May 2012 (actual)
- Study completion
- 8 May 2012 (actual)
- First posted
- 18 Sep 2017 (actual)
- Results
- Posted 16 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate and compare the plaque removal efficacy of four experimental toothpastes following a single timed brushing. Prior to each treatment visit, participants will abstain from oral hygiene for a period of 24 hours (+6hrs, -2hrs), immediately preceding a pre-brushing dental plaque evaluation. Participants will then brush once under supervision for one timed minute with each dentifrice after which re-disclosing and a post-brushing plaque assessment will be carried out.
Detailed description
This study will be a single centre, randomized, controlled, examiner blind, four treatment, four period crossover design. At the screening visit, following provision of written informed consent, eligible participants will be provided with a washout toothpaste and toothbrush for use at home during the study and for at least 14 days prior to the first treatment visit.
Participants will then be scheduled to attend the first of four treatment visits a minimum of 14 days later. For each treatment visit, participants must abstain from oral hygiene for a period of 24 hours (+6hrs, -2hrs), immediately preceding the pre-brushing dental plaque evaluation. All the participants will undergo an oral soft tissue (OST) examination followed by disclosing and a dental plaque assessment.
At the treatment visit 1 pre-brushing plaque assessment, those who develop a sufficient amount of plaque (Turesky mean score ≥ 2.00) will be randomized to study treatment. Participants will then brush once (1.5 grams [g] ± 0.05g of assigned toothpaste), under supervision of study staff for one timed minute, with one of the four test toothpastes after which re-disclosing and a post-brushing plaque assessment will be carried out. Participants will be allowed to brush with the washout paste following the post assessment plaque assessments.
A minimum of three days washout period will follow each treatment period during which period Participants will brush with a commercial washout toothpaste. Participants will complete four treatment visits and will brush once with each of the four test toothpastes throughout the course of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- The randomization schedule will indicate the treatment order sequence. Each subject will complete all four treatment regimens, one treatment regimen in each of the four treatment periods. This randomization will use a Williams Square layout and be provided by the Biostatistics Department, GSKCH.
| Arm | Type | Receives |
|---|---|---|
| Test product 1 | Experimental | Other: 67% Sodium Bicarbonate with 6 herbs plus 923parts per million (ppm) Sodium FluorideParticipants will brush once (1.5g ± 0.05g of Test product 1), under supervision of study staff for one timed minute |
| Test product 2 | Experimental | Other: 67% Sodium Bicarbonate without herbs plus 923 ppm Sodium FluorideParticipants will brush once (1.5g ± 0.05g of Test product 2), under supervision of study staff for one timed minute |
| Test product 3 | Experimental | Other: 62% Sodium Bicarbonate with 6 herbs and 5% w/w silica plus 923 ppm SodiumParticipants will brush once (1.5g ± 0.05g of Test product 3), under supervision of study staff for one timed minute |
| Test product 4 | Experimental | Other: 0% Sodium Bicarbonate without herbs plus 923ppm Sodium FluorideParticipants will brush once (1.5g ± 0.05g of Test product 4), under supervision of study staff for one timed minute |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- Aged at least 18 years
- Understands and is willing, able and likely to comply with all study procedures and restrictions
- Good general health with (in the opinion of the Investigator) no clinically significant and relevant abnormalities of medical history or dental history.
- Good dental health based on medical history and oral soft tissue examination at screening
Key exclusion criteria (25 listed)
- Women who are known to be pregnant or who are intending to become pregnant over the duration of the study
- Women who are breast-feeding
- Antibiotic treatment within 14 days prior to Treatment Visit 1 or throughout the study
- Any other treatment that would interfere with the study results/conduct, at the discretion of the examiner or investigator
- Diabetes mellitus type I or II
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 |
|---|---|---|
| 67% Sodium Bicarbonate with 6 herbs plus 923parts per million (ppm) Sodium FluorideToothpaste containing 67 percent (%) Sodium Bicarbonate with 6 herbs plus 923parts per million (ppm) Sodium Fluoride | Other | Test product 1 |
| 67% Sodium Bicarbonate without herbs plus 923 ppm Sodium FluorideToothpaste containing 67% Sodium Bicarbonate without herbs plus 923 ppm Sodium Fluoride | Other | Test product 2 |
| 62% Sodium Bicarbonate with 6 herbs and 5% w/w silica plus 923 ppm SodiumWhitening Toothpaste containing 62% Sodium Bicarbonate with 6 herbs and 5% w/w silica plus 923 ppm Sodium | Other | Test product 3 |
| 0% Sodium Bicarbonate without herbs plus 923ppm Sodium FluorideToothpaste containing 0% Sodium Bicarbonate without herbs plus 923ppm Sodium Fluoride | Other | Test product 4 |
Primary outcome
Mean Change From Baseline (Pre-brushing to Post-brushing) in Turesky Score After Single Supervised Use (Test Product 1 Versus [vs] Test Product 4) After 4 Weeks
Time frame: Baseline to 4 Weeks
The dental examiner used Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth.Overall plaque scores were calculated taking average over all tooth sites for participant.Plaque was first disclosed using dye solution followed by disclosing solution.They expectorated and rinsed with 10 milliliters (mL) water for 10 seconds (sec),expectorated again. Plaque was assessed with each tooth being divided into 6 areas including mesiofacial,facial,distofacial,mesiolingual,lingual,distolingual surfaces.Disclosed plaque was scored for each tooth surface separately as:0 No plaque;1 Slight flecks of plaque at cervical margin of the tooth;2 A thin continuous band of plaque(1 mm or smaller) at cervical margin of tooth;3 A band of plaque wider than 1 mm but covering less than 1/3 of the crown of tooth;4 Plaque covering at least 1/3 but less than 2/3 of crown of tooth;5 Plaque covering 2/3 or more of crown of tooth.Score range 0-5.Lower scores indicate less plaque area.
1 secondary outcome
Mean Change From Baseline (Pre-brushing to Post Brushing) in Turesky Score After Single Supervised Use for Test Products 1, 2, 3 and 4 After 4 Weeks
Time frame: Baseline to 4 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29971158Bosma ML, Milleman KR, Akwagyiram I, Targett D, Milleman JL. A randomised controlled trial to evaluate the plaque removal efficacy of sodium bicarbonate dentifrices in a single brushing clinical model. BDJ Open. 2018 Jun 4;4:17037. doi: 10.1038/s41405-018-0003-7. eCollection 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 study testing 67% Sodium Bicarbonate with 6 herbs plus 923parts per million (ppm) Sodium Fluoride, 67% Sodium Bicarbonate without herbs plus 923 ppm Sodium Fluoride and 62% Sodium Bicarbonate with 6 herbs and 5% w/w silica plus 923 ppm Sodium in people with Dental Plaque, 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 7 inclusion and 25 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 16 Oct 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Oct 2018). 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?
Mean Change From Baseline (Pre-brushing to Post-brushing) in Turesky Score After Single Supervised Use (Test Product 1 Versus [vs] Test Product 4) After 4 Weeks (time frame: Baseline to 4 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03285984, which also lists 1 linked publication.
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 Oct 2018.