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Not yet recruitingNCT06966492ILIMSIRUpdated Sep 3, 2026

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

A Phase 4 interventional study of Stannous Fluoride Toothpaste (SnF) in Gingival Inflammation, sponsored by Colgate Palmolive. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-03.

Sponsored by Colgate Palmolive · Phase 4, Interventional, and Basic science

Phase
Phase 4
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

Read the detailed description

An experimental gingivitis model will be used to explore changes in inflammation and the oral microbiome during gingivitis induction and resolution phases. Following consenting, screening, and enrollment, a dental intraoral (IO) scan or "digital impression" will be taken of the maxillary arch of each subject for the construction of an individual 3D printed tooth shield stent for use during the trial period. The customized stent (made of FDA approved resin material) will be used only on the experimental quadrant, and only during tooth brushing to prevent oral hygiene. Biological samples (blood, mucosal swabs, plaque biofilm, saliva, and gingival crevicular fluid) will be collected at each visit (pre-30 days, Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, and Day 28. Plaque and gingivitis examinations will be taken at each visit.

02

Conditions studied

  • Gingival Inflammation

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Keywords

  • induced gingivitis
03

In context

Gingivitis

631 studies on the registry are indexed under Gingivitis; 107 are open to participants now.

This study's planned enrollment of 20 is below the median of 66 across 507 interventional studies indexed under Gingivitis.

Browse Gingivitis studies →

Lead sponsor

Colgate Palmolive is the lead sponsor of 119 studies on the registry; 13 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 2 (6%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Males and females, between 18-65 years of age;
  2. Availability for the duration of the study;
  3. 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);
  4. Willingness to provide information related to their medical history;
  5. Minimum of 20 uncrowned permanent natural teeth (excluding third molars and crowns);
  6. Form signed.

Exclusion criteria

Exclusion Criteria:

  1. 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;
  2. Oral pathology or a history of allergy to testing products;
  3. 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;
  4. Subject participating in any other clinical study;
  5. Subject pregnant or breastfeeding;
  6. Subject allergic to oral care products and personal care consumer products
  7. Extended use of antibiotics or therapeutic mouthwash (eg: Chlorhexidine) any time during the three months prior to entry into the study;
  8. Ongoing use of medications known to affect the gingival tissues (i.e. calcium channel blockers, phenytoin, cyclosporine)
  9. Current smokers (or users of tobacco and vaping products) and subjects with a history of alcohol or drug abuse;
  10. An existing medical condition which prohibits eating or drinking for periods up to 4 hours.
  11. Individuals with orthodontic bands or removable partial dentures.
  12. Dental prophylaxis in the previous 3 months prior to the baseline examination
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 4
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
20 participants (estimated)

Study arms

  • Active comparator
    Control

    Regular fluoride toothpaste

    Drug: Stannous Fluoride Toothpaste (SnF)

  • No intervention
    Test

    Stannous fluoride containing toothpaste

Interventions

06

What researchers measure

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

07

Study locations

1 site
  • UT Health School of Dentistry
    Houston, Texas 77054, United States
    • Roger Arce, Assoc Prof, Dept. of Periodontics & Oral Hygiene, DDS, MS, PhD · Contactrarcemunoz@uth.edu · 713-486-4382
08

References and documents

Individual participant data

Plan to share: Yes — Non personal identifier information included in the results section of the publication. The IPD would be related to the clinical plaque and gingival inflammation data as well as inflammatory marker and microbiome data arising from the analysis of the biological samples.

Supporting information: Clinical study report

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Jun 2027, 9 months later.

Of 25 phase 4 interventional studies under Gingivitis, half reached primary completion within 3 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 4. This study's planned 9 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 30, 2025
First posted
May 12, 2025
StartEst.
Sep 2026
Primary completionEst.
Jun 2027
CompletionEst.
Jun 2027
Last update
Sep 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06966492
Lead sponsor
Colgate Palmolive
Responsible party
Sponsor
First posted
May 12, 2025
Start date
Sep 2026 (estimated)
Primary completion
Jun 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Sep 3, 2026

Study contacts

Roger Arce, DDS, MS, PhD
Contact
Roger.M.Arce@uth.tmc.edu
713 486 4382

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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