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

Procter & Gamble (P&G)

Status and phase: Active, not recruiting; Phase 2

Conditions: Gingivitis

Treatments: Drug: Sodium monofluorophosphate dentifrice; Drug: Sodium Fluoride Dentifrice; Drug: Stannous Fluoride Dentifrice

Study type: Interventional

Funder types: Industry

Identifiers

NCT06892834

2024026

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 4 patient groups

Positive Control

Active Comparator group

Description:

0.454% stannous fluoride, 0.533% zinc citrate

Treatment:

Drug: Stannous Fluoride Dentifrice

Experimental #1

Experimental group

Description:

0.243% NaF with 0.1% Hops, Humulus lupulus extract \[0.045% hops β-acids\]

Treatment:

Drug: Sodium Fluoride Dentifrice

Experimental #2

Experimental group

Description:

0.243% NaF with 0.5% Hops, Humulus lupulus extract \[0.225% hops β-acids\]

Treatment:

Drug: Sodium Fluoride Dentifrice

Negative Control

Active Comparator group

Description:

0.76% Sodium Monofluorophosphate

Treatment:

Drug: Sodium monofluorophosphate dentifrice