Dental Plaque
Conditions
Brief 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 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.
Interventions
OTHER67% Sodium Bicarbonate with 6 herbs plus 923parts per million (ppm) Sodium Fluoride
Toothpaste containing 67 percent (%) Sodium Bicarbonate with 6 herbs plus 923parts per million (ppm) Sodium Fluoride
OTHER67% Sodium Bicarbonate without herbs plus 923 ppm Sodium Fluoride
Toothpaste containing 67% Sodium Bicarbonate without herbs plus 923 ppm Sodium Fluoride
OTHER62% Sodium Bicarbonate with 6 herbs and 5% w/w silica plus 923 ppm Sodium
Whitening Toothpaste containing 62% Sodium Bicarbonate with 6 herbs and 5% w/w silica plus 923 ppm Sodium
OTHER0% Sodium Bicarbonate without herbs plus 923ppm Sodium Fluoride
Toothpaste containing 0% Sodium Bicarbonate without herbs plus 923ppm Sodium Fluoride
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 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. |
Participant flow
Recruitment details
Participants were recruited at a single center in the United States.
Pre-assignment details
A Total of 56 participants were screened and randomized in the study. All 56 participants completed the study.
Participants by arm
| Arm | Count |
|---|---|
| All Randomized Participants All randomized participants were included for baseline evaluation. | 56 |
| Total | 56 |
Baseline characteristics
| Characteristic | All Randomized Participants |
|---|---|
| Age, Continuous | 44.1 Years STANDARD_DEVIATION 11.87 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 51 Participants |
| Sex: Female, Male Female | 36 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 56 | 0 / 56 | 0 / 56 | 0 / 56 |
| other Total, other adverse events | 0 / 56 | 0 / 56 | 0 / 56 | 0 / 56 |
| serious Total, serious adverse events | 0 / 56 | 0 / 56 | 0 / 56 | 0 / 56 |
Outcome results
Primary
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.
Time frame: Baseline to 4 Weeks
Population: ITT (Intent-to-treat) population was the primary analysis population, which included all the participants who were randomized and had at least one post-baseline efficacy evaluation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Product 1 | 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 | Baseline | 2.90 Score on a scale | Standard Deviation 0.308 |
| Test Product 1 | 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 | Post Baseline | 1.76 Score on a scale | Standard Deviation 0.514 |
| Test Product 1 | 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 | Change from Baseline | -1.13 Score on a scale | Standard Deviation 0.43 |
| Test Product 4 | 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 | Baseline | 2.86 Score on a scale | Standard Deviation 0.309 |
| Test Product 4 | 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 | Post Baseline | 1.96 Score on a scale | Standard Deviation 0.47 |
| Test Product 4 | 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 | Change from Baseline | -0.90 Score on a scale | Standard Deviation 0.409 |
p-value: <0.000195% CI: [-0.27, -0.15]ANCOVA
Secondary
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.
Time frame: Baseline to 4 Weeks
Population: ITT (Intent-to-treat) population was the primary analysis population, which included all the participants who were randomized and had at least one post-baseline efficacy evaluation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Product 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 | Baseline | 2.90 Score on a scale | Standard Deviation 0.308 |
| Test Product 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 | Change from Baseline after 4 weeks | -1.13 Score on a scale | Standard Deviation 0.43 |
| Test Product 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 | Post Baseline | 1.76 Score on a scale | Standard Deviation 0.514 |
| Test Product 4 | 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 | Baseline | 2.92 Score on a scale | Standard Deviation 0.312 |
| Test Product 4 | 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 | Change from Baseline after 4 weeks | -1.14 Score on a scale | Standard Deviation 0.426 |
| Test Product 4 | 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 | Post Baseline | 1.78 Score on a scale | Standard Deviation 0.492 |
| Test Product 3 | 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 | Post Baseline | 1.77 Score on a scale | Standard Deviation 0.469 |
| Test Product 3 | 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 | Baseline | 2.89 Score on a scale | Standard Deviation 0.304 |
| Test Product 3 | 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 | Change from Baseline after 4 weeks | -1.11 Score on a scale | Standard Deviation 0.419 |
| Test Product 4 | 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 | Baseline | 2.86 Score on a scale | Standard Deviation 0.309 |
| Test Product 4 | 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 | Change from Baseline after 4 weeks | -0.90 Score on a scale | Standard Deviation 0.409 |
| Test Product 4 | 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 | Post Baseline | 1.96 Score on a scale | Standard Deviation 0.47 |