Last updated: 11/07/2018 12:29:32
An efficacy study of stain control of a 67% Sodium Bicarbonate containing toothpaste on Chlorhexidine tooth staining
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A study to evaluate the effect of a 67% Sodium Bicarbonate containing toothpaste on Chlorhexidine Digluconate tooth staining
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Single (Investigator)
Allocation:
Randomized
Primary outcomes:
Modified Lobene Stain Index (MLSI) at Week 6
Timeframe: Week 6 post treatment administration
Secondary outcomes:
Overall MLSI at Week 3
Timeframe: Week 3 post treatment administration
Overall facial MLSI at Week 3
Timeframe: Week 3 post treatment administration
Overall facial MLSI at Week 6
Timeframe: Week 6 post treatment administration
Overall interproximal MLSI at Week 3
Timeframe: Week 3 post treatment administration
Overall interproximal MLSI at Week 6
Timeframe: Week 6 post treatment administration
Overall gingival and interproximal MLSI at Week 3
Timeframe: Week 3 post treatment administration
Overall gingival and interproximal MLSI at Week 6
Timeframe: Week 6 post treatment administration
Interventions:
Enrollment:
160
Primary completion date:
2013-20-11
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
BMC Oral Health. 2016 Aug 25;16(1):79. doi: 10.1186/s12903-016-0271-3.
Medical condition
Oral Hygiene
Product
GSK3413212, chlorhexidine, sodium bicarbonate, sodium fluoride
Collaborators
Not applicable
Study date(s)
September 2013 to November 2013
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18 - 64 years
Accepts healthy volunteers
Yes
- Good oral health in the opinion of the investigator (excluding gingivitis)
- A minimum of 11 of the 12 permanent gradable anterior teeth at screening
- 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).
Inclusion and exclusion 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.
Trial location(s)
Location
Intertek - Maldon (formerly 4 Front Research Ltd)
Maldon, Essex, United Kingdom, CM9 5PN
Status
Study Complete
Location
Intertek - Manchester Science Park
Manchester, Not Available, United Kingdom, M15 6SE
Status
Study Complete
Location
Intertek 4-Front Research - Widnes
Widnes, Cheshire, United Kingdom, WA8 6PG
Status
Will Be Recruiting
Study documents
Statistical analysis plan
Available language(s): English
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2013-20-11
Actual study completion date
2013-20-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website