Gingivitis
Conditions
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 control dentifrice after 12 weeks of product use.
Detailed description
The participants will be enrolled and use their assigned treatment products for 12 weeks (\ 3 months).
Interventions
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).
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).
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).
Sponsors
Procter and Gamble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number Bleeding Sites | 4 weeks (~1 month) and 12 weeks (~3 months) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Löe-Silness Gingivitis Evaluation | 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 |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORAll Sum Research
All Sum Research
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 48.23 years STANDARD_DEVIATION 15.664 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 9 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 51 Participants |
| Region of Enrollment Canada | 30 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 2 / 30 | 0 / 30 | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 | 0 / 30 | 0 / 30 |
Outcome results
None listed