Last updated: 11/03/2018 22:25:11
Ability of four toothpastes to remove plaque
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Plaque Removal Efficacy of Four Dentifrices in a Single Brushing Model
Trial description: The aim of this study is to evaluate and compare the plaque removal efficacy of four experimental toothpastes following a single timed brushing. Prior to each treatment visit, participants will abstain from oral hygiene for a period of 24 hours (+6hrs, -2hrs), immediately preceding a pre-brushing dental plaque evaluation. Participants will then brush once under supervision for one timed minute with each dentifrice after which re-disclosing and a post-brushing plaque assessment will be carried out.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Mean change from baseline (pre-brushing to post-brushing) in Turesky score after single supervised use (test product 1 versus [vs] Test product 4) after 4 weeks
Timeframe: Baseline to 4 Weeks
Secondary outcomes:
Mean change from baseline (pre-brushing to post brushing) in Turesky score after single supervised use for Test products 1, 2, 3 and 4 after 4 weeks
Timeframe: Baseline to 4 Weeks
Interventions:
Other: 67% Sodium Bicarbonate with 6 herbs plus 923parts per million (ppm) Sodium Fluoride
Other: 67% Sodium Bicarbonate without herbs plus 923 ppm Sodium Fluoride
Other: 62% Sodium Bicarbonate with 6 herbs and 5% w/w silica plus 923 ppm Sodium
Other: 0% Sodium Bicarbonate without herbs plus 923ppm Sodium Fluoride
Enrollment:
56
Observational study model:
Not applicable
Primary completion date:
2012-08-05
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Dental Plaque
Product
GSK3413212, sodium bicarbonate, sodium fluoride
Collaborators
Not applicable
Study date(s)
March 2012 to May 2012
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
Yes
- Demonstrates understanding of the study 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 at least 18 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 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 at least 18 years
- Understands and is willing, able and likely to comply with all study procedures and restrictions
- Good general health with (in the opinion of the Investigator) no clinically significant and relevant abnormalities of medical history or dental history.
- Good dental health based on medical history and oral soft tissue examination at screening
- At least 20 gradable, natural, uncrowned teeth with both facial and lingual scoreable surfaces (gradable teeth are those where restorative materials cover less than 25% of the tooth surface graded)
- Plaque Score: Mean Turesky plaque score of ≥ 2.00 at treatment visit 1 pre-brushing plaque assessment
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
- Antibiotic treatment within 14 days prior to Treatment Visit 1 or throughout the study
- Any other treatment that would interfere with the study results/conduct, at the discretion of the examiner or investigator
- Diabetes mellitus type I or II
- Any disease systemic or localized, dental or non dental, which could put the participant’s health at risk or interfere with the study results/conduct, at the discretion of the examiner or investigator
- High levels of extrinsic stain or calculus deposits which might interfere with plaque assessments
- Dental condition/ disease requiring immediate treatment
- Pre-existing sensitivity to oral care products
- Severe gingivitis
- Periodontitis with pocket depth > 5mm affecting more than two teeth
- Moderate or severe recession
- Presence of orthodontic bands or appliances, extensive crowns, partial dentures, or fixed retainers on the maxillary or mandibular teeth
- Obvious active carious lesions needing immediate care
- Intra-oral decorative tattoos, or tongue and or lip piercing
- 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 or at baseline
- Known or suspected intolerance or hypersensitivity to the studymaterials (or closely related compounds) or any of their stated ingredients
- Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit
- Previous participation in this study
- Recent history (within the last year) of alcohol or other substance abuse
- Current use of Listerine or any antimicrobial mouth rinse containing Chlorhexidine or Cetrylpyridinium Chloride (CPC)
- Participant unwilling to abstain from using chewing tobacco (with or without tobacco)
- Participant unwilling to abstain from smoking on the morning prior to treatment visits
- An employee of the sponsor or the study site or members of their immediate family
Trial location(s)
No location data available.
Study documents
Statistical analysis plan
Available language(s): English
Clinical study report
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
Completed
Actual primary completion date
2012-08-05
Actual study completion date
2012-08-05
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
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