Bad Breath, Tooth Sensitivity
Conditions
Keywords
Gum Discomfort
Brief summary
This is a single-group, open-label, decentralized (virtual) clinical trial evaluating the effects of Larineco Remineralizing Gum on self-reported oral health outcomes in 40 generally healthy adults aged 18-57 years who experience bad breath, sensitive teeth, or gum discomfort. Participants will use the product once daily for 30 consecutive days and complete questionnaires at Baseline, Day 10, Day 20, and Day 30.
Interventions
DIETARY_SUPPLEMENTLarineco Remineralizing Gum
All enrolled participants receive Larineco Remineralizing Gum, a commercially available chewing gum product. Participants chew one piece of gum per day, after the second meal of the day, slowly and thoroughly for 15 minutes before discarding, for 30 consecutive days.
Sponsors
Larine C Corporation
Citruslabs
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Be male or female * Be adults aged 18-57 years * Self-reports experiencing at least one of the following oral concerns: bad breath, tooth sensitivity, or gum discomfort Generally healthy * Able to safely chew gum-style products * Willing to use the study product as directed, using one piece of gum per day, after the second meal of the day, and chewing thoroughly for 15 minutes before discarding, for the trial duration * Willing to maintain current oral hygiene habits (e.g., brushing frequency, flossing routine, toothpaste product) Resides in the United States Anyone who is willing to maintain their current diet, sleep pattern, and activity levels for the duration of the trial Has reliable access to an internet-enabled device to complete remote study assessments * Anyone willing to follow the study protocol * Willing to store the study product as directed and keep it away from children and pets
Exclusion criteria
* Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and mental health disorders * Known allergy or hypersensitivity to any ingredient in the study product * Any women who are pregnant, breastfeeding, or trying to conceive (or who will be at any point during the study period) * Severe or unmanaged dental or oral conditions (e.g., active oral infection, extensive untreated cavities, severe periodontitis, oral ulcers, or recent oral surgery within the past 30 days) * Loose or temporary dental work (e.g., temporary crowns, loose veneers, recently placed braces) that may be affected by chewing gummies * Diagnosed temporomandibular joint (TMJ) disorder or significant jaw pain that would make chewing uncomfortable * Known dry mouth/xerostomia or significant mouth sensitivity that may interfere with product tolerance or assessment * History of significant gastrointestinal sensitivity or digestive conditions that may be worsened by sugar alcohols, sweeteners, or functional ingredients * Recent dental procedure (within the past 14 days) or planned dental work during the study period that may interfere with assessments * Currently wearing fixed orthodontic appliances (e.g., traditional braces) that would significantly affect product use or assessments * Currently partaking in another research study or will be partaking in any other research study for the next 30 days, and at any point during this study's duration * Anyone who is undergoing treatment for cancer, or has had a serious illness requiring hospitalization in the last three months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oral Health | Baseline, day 10, day 20, day 30 | Change in self-reported oral health using questionnaires assessing breath freshness, tooth sensitivity, and gum comfort |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tooth surface smoothness | Baseline, day 10, day 20, day 30 | Change in self-reported tooth surface smoothness via self-report questionnaire on the Citruslabs study platform. |
| Mouth cleanliness | Baseline, Day 10, Day 20, and Day 30 | Change in self reported mouth cleanliness via self-report questionnaire on the Citruslabs study platform. |
Countries
United States
Outcome results
None listed