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CompletedNCT03936569Updated Jun 8, 2023

A Clinical Study to Assess the Plaque and Gingivitis Effects of a Stannous Fluoride Dentifrice

A Phase 4 interventional study of Marketed Toothpaste and Marketed Cavity Protection Toothpaste in Gingivitis, sponsored by Procter and Gamble. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-08.

Sponsored by Procter and Gamble · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Oct 2018, registered May 2019).
Phase
Phase 4
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The objective of this clinical study is to assess the effects of a 0.454% stannous fluoride dentifrice on gingivitis and plaque after 3 months when compared to a negative control.

02

Conditions studied

  • Gingivitis

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03

In context

Gingivitis

590 studies on the registry are indexed under Gingivitis; 104 are open to participants now.

This study's enrollment of 90 is above the median of 64 across 478 interventional studies indexed under Gingivitis.

Browse Gingivitis studies →

Lead sponsor

Procter and Gamble is the lead sponsor of 80 studies on the registry; none are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 10 (100%) have results posted.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Be at least 18 years of age;
  • Provide written informed consent prior to participation and be given a signed copy of the informed consent form;
  • Be in general good health as determined by the Investigator based on a review of the health history/update for participation in the trial;
  • Have at least 16 gradable teeth;
  • Agree to return for scheduled visits and follow the study procedures;
  • Agree to refrain from use of any non-study oral hygiene products for the duration of the study;
  • Agree to delay any elective dentistry, including dental prophylaxis, until the completion of the study.

Exclusion criteria

Exclusion Criteria:

  • Having taken antibiotic, anti-inflammatory, or anti-coagulant medications within 4 weeks of the Baseline Visit;
  • Have any oral conditions that could interfere with study compliance and/or examination procedures, such as widespread caries, soft or hard tissue tumor of the oral cavity, or advanced periodontal disease;
  • Removable oral appliances;
  • Fixed facial or lingual orthodontic appliances;
  • Self-reported pregnancy or lactation;
  • Any diseases or condition that might interfere with the safe participation in the study; and
  • Inability to undergo study procedures.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
90 participants (actual)

Study arms

  • Experimental
    Marketed Stannous Fluoride Toothpaste

    Brush twice daily

    Drug: Marketed Toothpaste

  • Placebo comparator
    Marketed Cavity Protection Toothpaste

    Brush twice daily

    Drug: Marketed Cavity Protection Toothpaste

Interventions

  • DrugMarketed Toothpaste

    Marketed stannous fluoride (0.454%) toothpaste

  • DrugMarketed Cavity Protection Toothpaste

    Marketed sodium monofluorophosphate (0.76 %) toothpaste

06

What researchers measure

Primary outcomes

  1. Löe-Silness Gingivitis Evaluation

    Löe-Silness Gingivitis Evaluation is a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation).

    Time frame: Baseline

  2. Löe-Silness Gingivitis Evaluation

    Löe-Silness Gingivitis Evaluation is a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation).

    Time frame: 1 Month

  3. Löe-Silness Gingivitis Evaluation

    Löe-Silness Gingivitis Evaluation is a validated assessment of gingival health looking at inflammation and bleeding based on a 4 point range 0 (normal gingiva) to 3 (severe inflammation).

    Time frame: 3 Months

Secondary outcomes

  1. Turesky Modified Quigley-Hein Index

    The Turesky Modified Quigley-Hein Index is a validated assessment of dental plaque based on a scale of 0 (no plaque/debris) to 5 (plaque covering two-thirds or more of the side of the crown or tooth).

    Time frame: Baseline

  2. Turesky Modified Quigley-Hein Index

    The Turesky Modified Quigley-Hein Index is a validated assessment of dental plaque based on a scale of 0 (no plaque/debris) to 5 (plaque covering two-thirds or more of the side of the crown or tooth).

    Time frame: 1 Month

  3. Turesky Modified Quigley-Hein Index

    The Turesky Modified Quigley-Hein Index is a validated assessment of dental plaque based on a scale of 0 (no plaque/debris) to 5 (plaque covering two-thirds or more of the side of the crown or tooth).

    Time frame: 3 Months

07

Study locations

1 site
  • Silverstone Research Group
    Las Vegas, Nevada 89146, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03936569
Lead sponsor
Procter and Gamble
Responsible party
Sponsor
First posted
May 3, 2019
Start date
Oct 29, 2018
Primary completion
Jan 25, 2019
Completion
Jan 25, 2019
Last update
Jun 8, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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