Assessing Gingivitis of 3 Different Dentifrices Compared to a Negative Control.

Launched by PROCTER AND GAMBLE · Mar 19, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of three different types of toothpaste on gingivitis, which is a common gum disease that causes inflammation and bleeding in the gums. The trial is comparing two experimental toothpastes that contain hops extract to a standard toothpaste with stannous fluoride, which is known to help with gum health, and a control toothpaste that does not contain any active ingredients. The main goal is to see how well these toothpastes work over a 12-week period in reducing gingivitis symptoms.

To participate in the trial, individuals must be at least 18 years old, have mild to moderate gingivitis, and have at least 20 healthy teeth. Participants should be in general good health and willing to follow specific guidelines, such as not using other oral hygiene products during the study and attending scheduled visits. Women who can become pregnant must use a reliable method of birth control. It's important to know that individuals with certain dental conditions or who have taken certain medications recently may not be eligible. Participants can expect to use one of the provided toothpastes and attend follow-up visits to monitor their gum health throughout the study.

Gender

ALL

Eligibility criteria

• 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 from use of any non-study oral hygiene products for the duration of the study; regular floss users can continue to floss in their customary manner.
• • Agree to delay any elective dentistry, including dental prophylaxis, until the completion of the study; and
• • Agree to refrain from any oral hygiene the morning of each visit.
• Exclusion Criteria:
• • Having taken antibiotic, anti-inflammatory, or anticoagulant medications within 4 weeks of the baseline visit;
• • Having 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, severe gingivitis, or advanced periodontal disease;
• • Females of child-bearing potential who are not using a medically approved method of birth control (i.e., hormonal contraceptives 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) or who have not been using hormonal birth control for a minimum of 3 months prior to study enrollment;
• • Taking medication that alters gingival appearance or gingival bleeding (e.g., calcium channel blockers, anticonvulsants, or immunosuppressants) within one month prior to study initiation;
• • Regularly (\>5x/week) using anti-gingivitis treatments (e.g., stannous fluoride toothpaste, or anti-gingivitis mouthwashes, such as those containing chlorohexidine) in the month prior to screening;
• • Removable oral appliances;
• • Fixed facial or lingual orthodontic appliances;
• • Have a positive pregnancy test (Clearblue) at baseline or self-reported pregnancy during the study; ;
• • Any diseases or condition that might interfere with the safe participation in the study according to the study investigator;
• • Inability to undergo study procedures; and
• • Allergic reactions to any of the study toothpastes and/or ingredients in the study toothpastes.