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Completed

NCT Number: NCT06892834

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

All Sum ResearchAll Sum Research Center Ltd.

Mississauga, Ontario, L5N 6J2, Canada

About this study

The participants will be enrolled and use their assigned treatment products for 12 weeks (~3 months).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stannous Fluoride Dentifrice

Drug

Each subject will be randomly assigned to one of four treatment products and will be asked to brush 2x a day (1 minute per brushing) for 12 weeks (~3 months).

Sodium Fluoride Dentifrice

Drug

Each subject will be randomly assigned to one of four treatment products and will be asked to brush 2x a day (1 minute per brushing) for 12 weeks (~3 months).

Sodium monofluorophosphate dentifrice

Drug

Each subject will be randomly assigned to one of four treatment products and will be asked to brush 2x a day (1 minute per brushing) for 12 weeks (~3 months).

Primary outcomes

  1. Number Bleeding Sites

    Time frame: 4 weeks (~1 month) and 12 weeks (~3 months)

Secondary outcomes

  1. Löe-Silness Gingivitis Evaluation

    Time frame: 4 weeks (~1 month) and 12 weeks (~3 months)

    scored on a scale of 0-3; 0 Normal gingiva; 1 Mild inflammation - slight change in colour, slight edema. No bleeding on probing; 2 Moderate inflammation - redness, edema, and glazing. Bleeding on probing; 3 Severe inflammation - marked redness, edema. Ulceration. Tendency to spontaneous bleeding

Sponsors and collaborators

Lead sponsor

Procter and Gamble

Industry

Registry information

Official study title

A Three-month Clinical Study to Assess the Gingivitis Effect of Various Dentifrices.

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 25, 2025
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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