Back to resultsAn Efficacy Study of Stain Control of a 67% Sodium Bicarbonate Containing Toothpaste on Chlorhexidine Tooth Staining
Primary Purpose
Oral Hygiene
Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Sodium bicarbonate/ Sodium Fluoride
Sodium fluoride
Chlorhexidine digluconate
Sponsored by
About this trial
This is an interventional prevention trial for Oral Hygiene
Eligibility Criteria
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.
Sites / Locations
- Intertek 4-Front Research - Widnes
- Intertek - Maldon (formerly 4 Front Research Ltd)
- Intertek - Manchester Science Park
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Active Comparator
Other
Arm Label
Sodium bicarbonate/ Sodium Fluoride toothpaste
Sodium fluoride toothpaste
Chlorhexidine digluconate mouthwash
Arm Description
Marketed Sodium bicarbonate toothpaste containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)
Non-sodium bicarbonate toothpaste containing 1450ppm fluoride as NaF
0.2% w/v Chlorhexidine digluconate mouthwash for rinsing post-brushing with study toothpastes
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
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).
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).
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).
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).
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).
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01962493
Brief Title
An Efficacy Study of Stain Control of a 67% Sodium Bicarbonate Containing Toothpaste on Chlorhexidine Tooth Staining
Official Title
A Study to Evaluate the Effect of a 67% Sodium Bicarbonate Containing Toothpaste on Chlorhexidine Digluconate Tooth Staining
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Hygiene
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sodium bicarbonate/ Sodium Fluoride toothpaste
Arm Type
Other
Arm Description
Marketed Sodium bicarbonate toothpaste containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)
Arm Title
Sodium fluoride toothpaste
Arm Type
Active Comparator
Arm Description
Non-sodium bicarbonate toothpaste containing 1450ppm fluoride as NaF
Arm Title
Chlorhexidine digluconate mouthwash
Arm Type
Other
Arm Description
0.2% w/v Chlorhexidine digluconate mouthwash for rinsing post-brushing with study toothpastes
Intervention Type
Other
Intervention Name(s)
Sodium bicarbonate/ Sodium Fluoride
Intervention Description
Toothpaste containing sodium bicarbonate and sodium fluoride as cosmetic
Intervention Type
Other
Intervention Name(s)
Sodium fluoride
Intervention Description
Toothpaste containing sodium fluoride as cosmetic
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine digluconate
Intervention Description
Mouthwash containing chlorhexidine digluconate
Primary Outcome Measure Information:
Title
Modified Lobene Stain Index (MLSI) at Week 6
Description
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
Secondary Outcome Measure Information:
Title
Overall MLSI at Week 3
Description
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
Title
Overall Facial MLSI at Week 3
Description
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
Title
Overall Facial MLSI at Week 6
Description
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
Title
Overall Interproximal MLSI at Week 3
Description
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
Title
Overall Interproximal MLSI at Week 6
Description
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
Title
Overall Gingival and Interproximal MLSI at Week 3
Description
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
Title
Overall Gingival and Interproximal MLSI at Week 6
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
Intertek 4-Front Research - Widnes
City
Widnes
State/Province
Cheshire
ZIP/Postal Code
WA8 6PG
Country
United Kingdom
Facility Name
Intertek - Maldon (formerly 4 Front Research Ltd)
City
Maldon
State/Province
Essex
ZIP/Postal Code
CM9 5PN
Country
United Kingdom
Facility Name
Intertek - Manchester Science Park
City
Manchester
ZIP/Postal Code
M15 6SE
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
27557865
Citation
Akwagyiram I, Butler A, Maclure R, Colgan P, Yan N, Bosma ML. A randomised clinical trial to evaluate the effect of a 67 % sodium bicarbonate-containing dentifrice on 0.2 % chlorhexidine digluconate mouthwash tooth staining. BMC Oral Health. 2016 Aug 25;16(1):79. doi: 10.1186/s12903-016-0271-3.
Results Reference
derived
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An Efficacy Study of Stain Control of a 67% Sodium Bicarbonate Containing Toothpaste on Chlorhexidine Tooth Staining
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