Assessing Gingivitis of 3 Different Dentifrices Compared to a Negative Control. (NCT06892834) | Clinical Trial Compass
CompletedPhase 2
Assessing Gingivitis of 3 Different Dentifrices Compared to a Negative Control.
Canada120 participantsStarted 2025-03-25
Plain-language summary
The primary objective of this study is to evaluate the effect of two experimental hops extract-containing dentifrices on gingivitis relative to a positive control 0.454% SnF2 dentifrice and a negative control dentifrice after 12 weeks of product use.
Who can participate
Age range18 Years
SexALL
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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; If female of child-bearing potential, agree to use a medically approved method of birth control for the duration of the study. Acceptable methods of medically approved birth control include: at least 3 months of use of a hormonal birth control (including oral contraceptives, hormone birth control patch, vaginal contraceptive ring, injectable contraceptives, or hormone implant), double-barrier method, intrauterine devices, non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s), vasectomy of partner at least 6 months prior to screening. Not applicable to females not of child-bearing potential (females who have undergone a sterilization procedure including hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior;
* If female and of child-bearing potential, agree to immediately inform the study investigator if they become pregnant;
* Have at least 20 gradable teeth;
* Have mild to moderate gingivitis with a range of 10 to 70% bleeding sites;
* Agree to return for scheduled visits and follow the study procedures;
* Agree to refrain fr…
What they're measuring
1
Number Bleeding Sites
Timeframe: 4 weeks (~1 month) and 12 weeks (~3 months)