About this trial
The objective of this clinical research study is to collect and analyze plaque and oral health measures in a population with high plaque/low gingivitis and high plaque/high gingivitis
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female volunteers at least 18 years of age and in general good health.
Willing and able to understand and sign the informed consent form.
Must have a whole mouth mean TPI score ≥ 3.25
N=40 must have moderate-severe gingivitis (Whole Mouth Mean MGI≥2.5 or percent bleeding sites based on EBI ≥20%) and N=40 must have mild gingivitis (Whole Mouth Mean MGI≤2.5 and percent bleeding sites based on EBI<20%)
Disqualifiers
Medical condition which requires premedication prior to dental visits/procedure.
Known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredients in the test products as determined by the study examiner.
Active disease of the hard oral tissues.
Significant oral soft tissue pathology, excluding plaque-induced gingivitis.
Trial design
Single group
Treatments tested in this trial
sodium monofluorophosphate toothpaste
DrugAll subjects will receive the same treatment for standardization
Treatment groups
Trial outcomes
Primary outcomes
Relative abundance of Streptococcus and Porphyromonas
Comparative relative abundance of Streptococcus and Porphyromonas in sites with high plaque/low gingivitis and high plaque/high gingivitis at Visit 3
Sponsors and contacts
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