NCT07270952

Brief Summary

This research was performed to find out the clinical efficacy and the anti-plaque and anti-gingivitis properties of a new oral health product (mouthwash and oral gel; StellaLife) compared to chlorhexidine. This is important since Chlorhexidine (CHX) has side effects, like it alters taste sensation, stains the teeth, and contains alcohol compared to the herbal based StellaLife.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2023

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 11, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 19, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 19, 2023

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

November 19, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 8, 2025

Completed
Last Updated

December 8, 2025

Status Verified

December 1, 2025

Enrollment Period

3 months

First QC Date

November 19, 2025

Last Update Submit

December 3, 2025

Conditions

Gingivitis

Keywords

experimental gingivitisStellaLifecrossover studyChlorhexidine

Outcome Measures

Primary Outcomes (1)

  • Probing pocket depth

    probing pocket depth measurement (in mm)

    4 weeks

Secondary Outcomes (1)

  • Gingival crevicular fluid (GCF) volume

    4 weeks

Other Outcomes (1)

  • Saliva analysis of bacteria

    4 weeks

Study Arms (2)

StellaLife

EXPERIMENTAL

StellaLife mouthwash for 2 weeks without tooth brushing

Drug: StellaLife

Chlorhexidine

EXPERIMENTAL
Drug: Chlorhexidine

Interventions

StellaLifeDRUG

StellaLife will be used in an experimental gingivitis model

StellaLife
ChlorhexidineDRUG

Chlorhexidine in 2 different arms in an experimental gingivitis model

Chlorhexidine

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy patients without periodontal disease

You may not qualify if:

  • no pregnant women or patient with immunocompromised systemic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stony Brook University

Stony Brook, New York, 11794, United States

Location

MeSH Terms

Conditions

Gingivitis

Interventions

Chlorhexidine

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: use of StellaLife for 2 weeks in the one arm (17 patients) and then mouth rinse with Chlorhexidine for 2 weeks (the same patients); another group (17 patients) will use first Chlorhexidine and then StellaLife (crossover study)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 19, 2025

First Posted

December 8, 2025

Study Start

January 11, 2023

Primary Completion

April 19, 2023

Study Completion

April 19, 2023

Last Updated

December 8, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)