Investigation of the Interplay Between Local Oral Inflammation, Microbiota and Systemic Immune Responses.

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorColgate Palmolive

About this trial

This is a clinical research study designed to measure changes in inflammation and the oral microbiome during a phase of good oral hygiene and the absence of oral hygiene. The goal of the study is to investigate the interplay between local oral inflammation, microbiota and systemic immune responses.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Males and females, between 18-65 years of age;

Availability for the duration of the study;

ASA 1 Good general health (absence of any self-reported systemic disease or condition that, in the opinion of the Principal Investigator, might constitute a risk to the subject while participating in the study. Examples include heart problems, valve/hip replacements, etc);

Willingness to provide information related to their medical history;

Disqualifiers

Subjects with more that 2 sites with pocket depth of > 4 mm and those presenting purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone;

Oral pathology or a history of allergy to testing products;

Subject using anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory medication or daily analgesics within one month prior to the start of the study or scheduled to start such intake during the course of the study; to be defined by the dental examiner;

Subject participating in any other clinical study;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Stannous Fluoride Toothpaste (SnF)

    Drug

    stannous fluoride toothpaste

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: ControlActive comparator 1 intervention
Group B: TestNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Gingival Bleeding Index described by Ainamo & Bay, 1976

Gingival Bleeding Index (Ainamo \& Bay, 1976) The six surfaces of teeth will be scored and recorded for absence or presence of bleeding after gentle probing.

Time frame
From enrollment and at each successive visit until to the end of the study

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Colgate Palmolive

Lead sponsor

The University of Texas Health Science Center, Houston

Collaborator

This trial is not recruiting at the moment. You can still explore other options: