- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07692581
A Clinical Trial to Evaluate the Effects of Larineco Remineralizing Gum on Oral Health, Breath Freshness, Tooth Sensitivity, and Gum Comfort
July 2, 2026 updated by: Larine C Corporation
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nevada
-
Las Vegas, Nevada, United States, 89118
- Citruslabs
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Larineco 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oral Health
Time Frame: Baseline, day 10, day 20, day 30
|
Change in self-reported oral health using questionnaires assessing breath freshness, tooth sensitivity, and gum comfort
|
Baseline, day 10, day 20, day 30
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tooth surface smoothness
Time Frame: Baseline, day 10, day 20, day 30
|
Change in self-reported tooth surface smoothness via self-report questionnaire on the Citruslabs study platform.
|
Baseline, day 10, day 20, day 30
|
|
Mouth cleanliness
Time Frame: Baseline, Day 10, Day 20, and Day 30
|
Change in self reported mouth cleanliness via self-report questionnaire on the Citruslabs study platform.
|
Baseline, Day 10, Day 20, and Day 30
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 2, 2026
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
August 1, 2026
Study Registration Dates
First Submitted
July 2, 2026
First Submitted That Met QC Criteria
July 2, 2026
First Posted (Actual)
July 9, 2026
Study Record Updates
Last Update Posted (Actual)
July 9, 2026
Last Update Submitted That Met QC Criteria
July 2, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LARIN-67330
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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