NCT07692581

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

July 2, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 9, 2026

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Completed
Last Updated

July 9, 2026

Status Verified

July 1, 2026

Enrollment Period

1 month

First QC Date

July 2, 2026

Last Update Submit

July 2, 2026

Conditions

Keywords

Gum Discomfort

Outcome Measures

Primary Outcomes (1)

  • Oral Health

    Change in self-reported oral health using questionnaires assessing breath freshness, tooth sensitivity, and gum comfort

    Baseline, day 10, day 20, day 30

Secondary Outcomes (2)

  • Tooth surface smoothness

    Baseline, day 10, day 20, day 30

  • Mouth cleanliness

    Baseline, Day 10, Day 20, and Day 30

Study Arms (1)

Larineco Remineralizing Gum

EXPERIMENTAL
Dietary Supplement: Larineco Remineralizing Gum

Interventions

Larineco Remineralizing GumDIETARY_SUPPLEMENT

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.

Larineco Remineralizing Gum

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Citruslabs

Las Vegas, Nevada, 89118, United States

Location

MeSH Terms

Conditions

HalitosisDentin Sensitivity

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsTooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2026

First Posted

July 9, 2026

Study Start

July 2, 2026

Primary Completion

August 1, 2026

Study Completion

August 1, 2026

Last Updated

July 9, 2026

Record last verified: 2026-07

Locations