N/A
N=56
Ability of Four Toothpastes to Remove Plaque
Dental Plaque
Bottom Line
View on ClinicalTrials.gov: NCT03285984 ↗Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcome: Primary: 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 — 2.90; 2.86; 1.76; 1.96 Score on a scale — p=<.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 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 (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
2.90; 2.86; 1.76; 1.96; -1.13; -0.90 | <.0001 sig |
| SECONDARY 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 |
2.90; 2.92; 2.89; 2.86; 1.76; 1.78 | — |
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 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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03285984). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.