Clinical Study to Collect and Analyze Dental Plaque and Oral Health Measures in a Population With High Plaque/Low Gingivitis and High Plaque/High Gingivitis

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorColgate Palmolive

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • sodium monofluorophosphate toothpaste

    Drug

    All subjects will receive the same treatment for standardization

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Brushing with sodium fluoride toothpasteOther 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
23-26 days

Secondary outcomes

Other outcomes

Sponsors and contacts

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