Status:
COMPLETED
Assessing Gingivitis of 3 Different Dentifrices Compared to a Negative Control.
Lead Sponsor:
Procter and Gamble
Conditions:
Gingivitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 19 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06892834
Start Date
March 25 2025
End Date
June 19 2025
Last Update
July 2 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
All Sum ResearchAll Sum Research Center Ltd.
Mississauga, Ontario, Canada, L5N 6J2