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Phase 3 N=32 Randomized Single-blind Prevention

Evaluate Dental Plaque Benefit of a Preventive Treatment Gel

Dental Plaque

Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Mean Turesky Modified Quigley-Hein Index at Day 4 — 1.83; 1.96 score on a scale

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Preventive Gel (Drug); Marketed Control (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Procter and Gamble
Primary completion
Jun 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Mean Turesky Modified Quigley-Hein Index at Day 4
1.83; 1.96
SECONDARY
Mean Turesky Modified Quigley-Hein Index at Baseline
2.19; 2.22
SECONDARY
Digital Plaque Imaging
8.14; 10.95
SECONDARY
Overall Baseline Mean Digital Plaque Imaging
6.57; 7.29

Summary

The objective of the study is to evaluate anti-plaque efficacy of a preventive treatment gel in a modified 4-day plaque model.

Eligibility Criteria

Inclusion Criteria

  • Provide written informed consent prior to participation and be given a signed copy of the informed consent form;
  • Be 18 years of age or older;
  • Agree not to participate in any other oral/dental product studies during the study;
  • Agree to delay any elective dentistry (including dental prophylaxis) until the study has been completed;
  • Agree to refrain from the use of any non-study oral hygiene products (subjects who are regular flossers will be allowed to floss during acclimation and wash-out periods);
  • Agree to use an oral hygiene product that contains stannous fluoride;
  • Agree to refrain from any form of non-specified oral hygiene during the treatment period, including the use of products such as floss, toothpicks for plaque removal, and chewing gum;
  • Agree to refrain from any oral hygiene, eating and drinking after 11:00 PM the evening before plaque measurements on Day 0 and Day 4 of the treatment periods;
  • Agree to return for all scheduled visits and follow study procedures;
  • Possess a minimum of 20 natural teeth with scorable facial and lingual surfaces, of which at least 4 are molars; and,
  • Be in good general health, as determined by the Investigator/designee based on a review of the health history/update for participation in the study.

Exclusion Criteria:• Have a medical condition requiring pre-medication prior to dental procedures;

  • Have taken antibiotics within 2 weeks of the acclimation period or anticipate taking antibiotics at any time during the study;
  • Have a history of allergies or hypersensitivity to dyes or dentifrices that contain stannous fluoride;
  • Have removable or orthodontic appliances which interfere with obtaining 20 gradable teeth;
  • Have previously demonstrated an inability to comply with study visit requirements;
  • Have rampant caries, open or untreated caries, severe gingivitis or advanced periodontitis requiring prompt treatment; or,
  • Present with any disease or condition(s) that could be expected to interfere with examination procedures or the subject's safe completion of the study.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03546491). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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