Clinical trial NCT01962493: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Oral Hygiene
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2013-10-14
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Modified Lobene Stain Index (MLSI) at Week 6
timeFrame: Week 6 post treatment administration
Secondary outcomes:
measure: Overall MLSI at Week 3
timeFrame: Week 3 post treatment administration
measure: Overall Facial MLSI at Week 3
timeFrame: Week 3 post treatment administration
measure: Overall Facial MLSI at Week 6
timeFrame: Week 6 post treatment administration
measure: Overall Interproximal MLSI at Week 3
timeFrame: Week 3 post treatment administration
measure: Overall Interproximal MLSI at Week 6
timeFrame: Week 6 post treatment administration
measure: Overall Gingival and Interproximal MLSI at Week 3
timeFrame: Week 3 post treatment administration
measure: Overall Gingival and Interproximal MLSI at Week 6
timeFrame: Week 6 post treatment administration
Other outcomes:
Locations:
city: Widnes
country: United Kingdom
facility: Intertek 4-Front Research - Widnes
state: Cheshire
city: Maldon
country: United Kingdom
facility: Intertek - Maldon (formerly 4 Front Research Ltd)
state: Essex
city: Manchester
country: United Kingdom
facility: Intertek - Manchester Science Park
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
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.