The aim of this study is to evaluate the feasibility, sensitivity, and interpretability of gingival crevicular fluid (GCF) cytokine biomarkers as early indicators of tissue recovery following use of commercial dentifrice compared with a standard fluoride dentifrice in experimental gingivitis model, after 14 days twice daily use.
This will be a single-center, randomized, controlled, double-blind, split-mouth, 2 treatment arms, parallel group, stratified clinical study in healthy participants with gingivitis and plaque accumulation induced using an experimental gingivitis model, to characterize GCF biomarkers associated with gingival health over time following use of a Test Toothpaste containing stannous fluoride (SnF2) compared to a Regular Fluoride Toothpaste (Reference Toothpaste) on GCF biomarkers. Sufficient participants will be screened to randomize approximately 20 participants (10 per group) to ensure approximately 18 (9 per group) evaluable participants complete the entire study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
20
A marketed toothpaste containing 0.454 percent (%) SnF2.
A marketed toothpaste containing 0.3152% Weight on Weight (w/w) Sodium Fluoride (NaF).
University of Birmingham
Birmingham, United Kingdom
GCF Biomarkers Profile Assessment at Baseline (Day 0), Day 3, 7, 10 and 14
GCF samples will be collected from the mesio-buccal site of the selected teeth. Proteins will be eluted from the pooled collection papers and then analysed by proximity extension assay.
Time frame: Baseline (Day 0) and Day 3, 7, 10 and 14
GCF Volume at Baseline (Day 0), Day 3, 7, 10 and 14
GCF samples will be collected from the mesio-buccal site of the selected teeth. The volume of GCF collected on each strip will be quantified using a Periotron device, which measures the fluid absorbed by the PerioPaper strips and provides an estimate of GCF volume.
Time frame: Baseline (Day 0) and Day 3, 7, 10 and 14
Change from Baseline in Modified Gingival Index (MGI) at Day 3, 7, 10 and 14
The MGI assessment is a non-invasive visual evaluation to assess the symptoms of gingivitis. It will be assessed for all evaluable teeth, four sites per test and reference tooth. For each tooth, 3 scores will be recorded and will be scored on a 5-point scale ranging from 0 to 4, where 0 equals (=) Absence of inflammation, 1= Mild inflammation: slight change in color, little change in texture of any portion of the marginal or papillary gingival unit, 2= Mild inflammation: criteria as (1) but involving the entire marginal or papillary gingival unit, 3= Moderate inflammation: glazing, redness, edema, and/or hypertrophy of the marginal or papillary gingival unit, 4= Severe inflammation: marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. Change from baseline will be calculated by subtracting the Baseline score from the score at the indicated timepoints. Lower score will indicate an improvement in condition.
Time frame: Baseline (Day 0) and Day 3, 7, 10 and 14
Change from Baseline in Turesky modification of the Quigley Hein Plaque Index (TPI) at Day 3, 7, 10 and 14
TPI will be used to assess plaque on all gradable test and reference teeth. The plaque will first be disclosed using a plaque disclosing dye solution. The disclosed plaques will be scored using a 6-point scale ranging from 0 to 5, where 0= No plaque, 1= Separate flecks of plaque at the cervical margin, 2= Thin continuous band of plaque \[up to 1 millimeter (mm)\] at the cervical margin, 3= Band of plaque wider than 1 mm but covering less than (\<) 1/3 of the tooth surface, 4= Plaque covering more than equal to (\>=) 1/3 but \< 2/3 of the tooth surface, 5= Plaque covering \>= 2/3 of the tooth surface. Change from baseline will be calculated by subtracting the Baseline score from the score at the indicated timepoints. Lower score will indicate improvement in gingival health.
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Time frame: Baseline (Day 0) and Day 3, 7, 10 and 14