Status:
COMPLETED
Ability of Four Toothpastes to Remove Plaque
Lead Sponsor:
GlaxoSmithKline
Conditions:
Dental Plaque
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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 abstai...
Detailed Description
This study will be a single centre, randomized, controlled, examiner blind, four treatment, four period crossover design. At the screening visit, following provision of written informed consent, eligi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 27 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 8 2012
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT03285984
Start Date
March 27 2012
End Date
May 8 2012
Last Update
October 16 2018
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