Last updated: 05/15/2019 07:39:17
Efficacy of three experimental toothpastes to remove plaque
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Dose Response of Three Experimental Dentifrices in Plaque Removal in a Single Brushing Model
Trial description: The Dose response of three experimental toothpastes (test product 1, test product 2 and test product 3) to remove plaque after a single brushing, compared to a positive control and negative control dentifrice will be evaluated.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Change from baseline (pre-brushing) after a single brushing treatment (post-brushing) Turesky Modification of Quigley Hein Plaque Index (TPI), positive control versus [vs.] negative control
Timeframe: Up to 5 weeks
Secondary outcomes:
Change from baseline (pre-brushing) after a single brushing treatment (post-brushing) Turesky Modification of Quigley Hein Plaque Index (Test product 1, 2 and 3 vs Negative control)
Timeframe: Up to 5 weeks
Change from baseline (Pre-brushing) after a single brushing treatment (Post-brushing) Turesky Modification of Quigley Hein Plaque Index (Test product 1, 2 and 3 vs Positive control)
Timeframe: Up to 5 weeks
Interventions:
Drug: 20% w/w sodium bicarbonate
Drug: 35% w/w sodium bicarbonate
Drug: 50% w/w sodium bicarbonate
Drug: 67% w/w sodium bicarbonate
Drug: 0% w/w sodium bicarbonate
Enrollment:
75
Observational study model:
Not applicable
Primary completion date:
2017-02-02
Time perspective:
Not applicable
Clinical publications:
Jose A, Parkinson CR, Manger C, Bielfeldt S, Krause C. Randomized Clinical Dose-Response Study to Evaluate Plaque Removal by Three Experimental Sodium Bicarbonate Toothpastes Using a Single Brushing Model. J Clin Dent. 2018 Dec;29(4):75-80. PMID:30942962
Medical condition
Dental Plaque
Product
sodium bicarbonate, sodium fluoride
Collaborators
Not applicable
Study date(s)
December 2016 to February 2017
Type
Interventional
Phase
n/a
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
Yes
- Demonstrates understanding of the study procedures, restrictions 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 between 18- 65 years
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- Demonstrates understanding of the study procedures, restrictions 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 between 18- 65 years
- Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or oral/dental examination. Absence of any condition that would impact on the participant's safety or wellbeing or affect the individual’s ability to understand and follow study procedures and requirements.
- Good dental health based on medical history and oral soft tissue examination at screening, a minimum of 20 permanent gradable teeth (Gradable teeth are those where restorative materials cover less than 25% of the tooth surface to be graded), and mean Turesky plaque score of ≥ 2.00 at Visit 1 and Visit 2 (pre-brushing plaque assessment).
- Understands and is willing, able and likely to comply with all study procedures and restrictions.
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.
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- Participation in another clinical study: cosmetic studies within 14 days of the screening visit or receipt of an investigational drug within 30 days of the screening visit and previous participation in this study.
- Recent history (within the last year) of alcohol or other substance abuse.
- An employee of the sponsor or the study site or members of their immediate family and an employee of any toothpaste manufacturer or their immediate family.
- Antibiotic treatment within 14 days prior to Visit 2 or throughout the study, any other treatment that would interfere with the study outcomes, at the discretion of the examiner or investigator.
- High levels of extrinsic stain or calculus deposits which might interfere with plaque assessments at the discretion of the investigator, dental conditions / disease requiring immediate treatment, pre-existing sensitivity to oral care products, severe gingivitis that may, in the opinion of the investigator, compromise the study or the oral health of the participants if they participate in the study, presence of orthodontic bands or appliances, extensive crowns, partial dentures, or fixed retainers on the maxillary or mandibular teeth, active carious lesions needing immediate care, 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, have current active caries or periodontitis that may, in the opinion of the investigator, compromise the study or the oral health of the participants if they participate in the study, restorations in a poor state of repair that may, in the opinion of the investigator, compromise the study or the oral health of the participants if they participate in the study, use of a chlorhexidine mouthwash within 14 days of Visit 2 or through the study and current use of Listerine, Corsodyl or any antimicrobial mouth rinse or throughout the study.
- Participant unwilling to abstain from using chewing tobacco (with or without tobacco) and Participant unwilling to abstain from smoking tobacco or E-cigarettes for 4 hours prior to all visits and until all dental assessments are completed at each visit.
Trial location(s)
Location
GSK Investigational Site
Schenefeld, Schleswig-Holstein, Germany, 22869
Status
Study Complete
Study documents
Statistical analysis plan
Available language(s): English
Protocol
Available language(s): English
Clinical study report
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
Completed
Actual primary completion date
2017-02-02
Actual study completion date
2017-02-02
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
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Additional information
Randomized Clinical Dose-Response Study to Evaluate Plaque Removal by Three Experimental Sodium Bicarbonate Toothpastes Using a Single Brushing Model.
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