Oral Hygiene
Conditions
Brief summary
The aim of this study is to compare the stain effect on teeth of twice daily brushing with a 67% sodium bicarbonate containing toothpaste versus standard toothpaste (not containing sodium bicarbonate) for six weeks whilst using a chlorhexidine digluconate 0.2% mouthwash.
Interventions
OTHERSodium bicarbonate/ Sodium Fluoride
Toothpaste containing sodium bicarbonate and sodium fluoride as cosmetic
OTHERSodium fluoride
Toothpaste containing sodium fluoride as cosmetic
Mouthwash containing chlorhexidine digluconate
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Good oral health in the opinion of the investigator (excluding gingivitis) * A minimum of 11 of the 12 permanent gradable anterior teeth at screening * Stain levels on the buccal surfaces of the 6 maxillary and 6 mandibular anterior teeth need to be at least mild and present on a minimum of 4 teeth * Modification of the Lobene Stain Index - At Visit 2, a baseline total MLSI Intensity x Area score (four sites per tooth) of greater than or equal to 8 for facial surfaces of anterior teeth.
Exclusion criteria
* Pregnant women or women who are intending to become pregnant over the duration of the study * Known or suspected intolerance or hypersensitivity to Chlorhexidine or other study materials (or closely related compounds). * Current use of Chlorhexidine, Cetylpyridinium Chloride or any marketed mouthwash * Past or current use of any drug which is known to be associated with tooth discolouration within 30 days of screening or during the study period. * Recent history (within the last 1 year) of alcohol or other substance abuse * Dental conditions / disease requiring immediate treatment; Crowns or veneers on more than one anterior tooth; pre-existing sensitivity to oral care products; severe periodontitis; severe recession; dental implants; active carious lesions on anterior teeth; oral lesions/manifestations; prone to aphthous stomatitis and ulceration etc. * Participant with untreated oral mucosal disease which in the opinion of the investigator could interfere with the study. * Medical condition which would require the use of prophylactic antibiotics prior to dental cleanings * Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any medical disorder that would make the participant unlikely to fully complete the study or any condition that presents undue risk from the study treatment or procedures in the opinion of the investigator or dental assessor.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Lobene Stain Index (MLSI) at Week 6 | Week 6 post treatment administration | An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 6 weeks. The intensity of stain was scored 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 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. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Facial MLSI at Week 3 | Week 3 post treatment administration | An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 3 weeks. The intensity of stain was scored 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 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. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score). |
| Overall Facial MLSI at Week 6 | Week 6 post treatment administration | An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 6 weeks. The intensity of stain was scored 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 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. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score). |
| Overall Interproximal MLSI at Week 3 | Week 3 post treatment administration | An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 3 weeks. The intensity of stain was scored 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 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. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score). |
| Overall MLSI at Week 3 | Week 3 post treatment administration | An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 3 weeks. The intensity of stain was scored 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 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. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score). |
| Overall Gingival and Interproximal MLSI at Week 3 | Week 3 post treatment administration | An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 3 weeks. The intensity of stain was scored 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 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. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score). |
| Overall Gingival and Interproximal MLSI at Week 6 | Week 6 post treatment administration | An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 6 weeks. The intensity of stain was scored 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 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. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score). |
| Overall Interproximal MLSI at Week 6 | Week 6 post treatment administration | An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 6 weeks. The intensity of stain was scored 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 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. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score). |
Countries
United Kingdom
Participant flow
Recruitment details
The study was conducted at two sites in the UK. Participants were recruited from the site's database and by use of advertisements.
Pre-assignment details
In total 314 participants were screened and 160 participants were randomised of whom 150 completed the study. Of the 10 participants that did not completed the study, 3 had adverse events; 1 had protocol violation and 6 had withdrawal of consent.
Participants by arm
| Arm | Count |
|---|---|
| NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner. | 78 |
| NaF Toothpaste + Chlorhexidine Digluconate Mouthwash Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner. | 82 |
| Total | 160 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 2 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 2 |
Baseline characteristics
| Characteristic | NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash | NaF Toothpaste + Chlorhexidine Digluconate Mouthwash | Total |
|---|---|---|---|
| Age, Continuous | 39.8 Years STANDARD_DEVIATION 11.08 | 39.5 Years STANDARD_DEVIATION 10.87 | 39.6 Years STANDARD_DEVIATION 10.94 |
| Sex: Female, Male Female | 56 Participants | 60 Participants | 116 Participants |
| Sex: Female, Male Male | 22 Participants | 22 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 39 / 78 | 41 / 82 |
| serious Total, serious adverse events | 1 / 78 | 0 / 82 |
Outcome results
Primary
Modified Lobene Stain Index (MLSI) at Week 6
An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 6 weeks. The intensity of stain was scored 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 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. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).
Time frame: Week 6 post treatment administration
Population: The efficacy analysis was performed on the Intent-to-treat (ITT) population which consisted of all participants who were randomized and received the study treatment and completed one of the post-baseline efficacy assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash | Modified Lobene Stain Index (MLSI) at Week 6 | 0.97 Score on a Scale | Standard Deviation 0.929 |
| NaF Toothpaste + Chlorhexidine Digluconate Mouthwash | Modified Lobene Stain Index (MLSI) at Week 6 | 1.22 Score on a Scale | Standard Deviation 1.008 |
Comparison: Null hypothesis stated that there was no difference between treatment groupsp-value: 0.131395% CI: [-0.51, 0.1]ANCOVA
Secondary
Overall Facial MLSI at Week 3
An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 3 weeks. The intensity of stain was scored 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 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. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).
Time frame: Week 3 post treatment administration
Population: The efficacy analysis was performed on the Intent-to-treat (ITT) population which consisted of all participants who were randomized and received the study treatment and completed one of the post-baseline efficacy assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash | Overall Facial MLSI at Week 3 | 0.27 Score on a Scale | Standard Deviation 0.557 |
| NaF Toothpaste + Chlorhexidine Digluconate Mouthwash | Overall Facial MLSI at Week 3 | 0.41 Score on a Scale | Standard Deviation 0.542 |
Secondary
Overall Facial MLSI at Week 6
An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 6 weeks. The intensity of stain was scored 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 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. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).
Time frame: Week 6 post treatment administration
Population: The efficacy analysis was performed on the Intent-to-treat (ITT) population which consisted of all participants who were randomized and received the study treatment and completed one of the post-baseline efficacy assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash | Overall Facial MLSI at Week 6 | 0.67 Score on a Scale | Standard Deviation 0.885 |
| NaF Toothpaste + Chlorhexidine Digluconate Mouthwash | Overall Facial MLSI at Week 6 | 0.96 Score on a Scale | Standard Deviation 0.992 |
Secondary
Overall Gingival and Interproximal MLSI at Week 3
An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 3 weeks. The intensity of stain was scored 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 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. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).
Time frame: Week 3 post treatment administration
Population: The efficacy analysis was performed on the Intent-to-treat (ITT) population which consisted of all participants who were randomized and received the study treatment and completed one of the post-baseline efficacy assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash | Overall Gingival and Interproximal MLSI at Week 3 | 0.56 Score on a Scale | Standard Deviation 0.713 |
| NaF Toothpaste + Chlorhexidine Digluconate Mouthwash | Overall Gingival and Interproximal MLSI at Week 3 | 0.73 Score on a Scale | Standard Deviation 0.711 |
Secondary
Overall Gingival and Interproximal MLSI at Week 6
An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 6 weeks. The intensity of stain was scored 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 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. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).
Time frame: Week 6 post treatment administration
Population: The efficacy analysis was performed on the Intent-to-treat (ITT) population which consisted of all participants who were randomized and received the study treatment and completed one of the post-baseline efficacy assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash | Overall Gingival and Interproximal MLSI at Week 6 | 1.18 Score on a Scale | Standard Deviation 1.134 |
| NaF Toothpaste + Chlorhexidine Digluconate Mouthwash | Overall Gingival and Interproximal MLSI at Week 6 | 1.52 Score on a Scale | Standard Deviation 1.271 |
Secondary
Overall Interproximal MLSI at Week 3
An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 3 weeks. The intensity of stain was scored 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 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. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).
Time frame: Week 3 post treatment administration
Population: The efficacy analysis was performed on the Intent-to-treat (ITT) population which consisted of all participants who were randomized and received the study treatment and completed one of the post-baseline efficacy assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash | Overall Interproximal MLSI at Week 3 | 0.66 Score on a Scale | Standard Deviation 0.828 |
| NaF Toothpaste + Chlorhexidine Digluconate Mouthwash | Overall Interproximal MLSI at Week 3 | 0.87 Score on a Scale | Standard Deviation 0.82 |
Secondary
Overall Interproximal MLSI at Week 6
An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 6 weeks. The intensity of stain was scored 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 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. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).
Time frame: Week 6 post treatment administration
Population: The efficacy analysis was performed on the Intent-to-treat (ITT) population which consisted of all participants who were randomized and received the study treatment and completed one of the post-baseline efficacy assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash | Overall Interproximal MLSI at Week 6 | 1.44 Score on a Scale | Standard Deviation 1.396 |
| NaF Toothpaste + Chlorhexidine Digluconate Mouthwash | Overall Interproximal MLSI at Week 6 | 1.87 Score on a Scale | Standard Deviation 1.525 |
Secondary
Overall MLSI at Week 3
An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 3 weeks. The intensity of stain was scored 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 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. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).
Time frame: Week 3 post treatment administration
Population: The efficacy analysis was performed on the Intent-to-treat (ITT) population which consisted of all participants who were randomized and received the study treatment and completed one of the post-baseline efficacy assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash | Overall MLSI at Week 3 | 0.46 Score on a Scale | Standard Deviation 0.572 |
| NaF Toothpaste + Chlorhexidine Digluconate Mouthwash | Overall MLSI at Week 3 | 0.59 Score on a Scale | Standard Deviation 0.563 |