Protocol Efficacy of Mouthwashes in Experimental Gingivitis

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.

Study Overview

• Status: Completed
• Conditions: Gingivitis
• Intervention / Treatment: Drug: StellaLife; Drug: Chlorhexidine

Detailed Description

Objectives: To evaluate 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.

Material and Methods: Two different groups of subjects will be selected for this study. All study participants will have a complete periodontal charting at the initial examination visit (screening visit) and prophylaxis visit. Specifically, periodontal charting with plaque assessment (using disclosing agents), probing measurements (in mm), Gingival Index and gingival crevicular fluid (GCF) analysis (in 2 teeth) will be included.

At the first visit an oral test of the saliva using the OralDNALabs will be used to determine the bacterial load and quality. Then, a professional cleaning and polishing of the teeth will be performed.

The subjects of the Group 1 (test) will use initially a mouth rinse 3x/day with StellaLife (test group) for 1-2 min and one minute test gel (with ingredients) at the gingival margin for 1 min. for a total period of 2 weeks. Toothbrushing and flossing will not be allowed by the subjects. Subjects must avoid eating or drinking for 15 min. after the use of the mouthwash and gel. The gel should be applied for 1 min' to ' apply gel evenly using Q-tip at the neck of the teeth (cervico-gingival junction) on both sides of the teeth.

An oral test of the saliva using the OralDNALabs will be used to determine the bacterial load and quality. Then, a professional cleaning and polishing of the teeth will be performed.

Then, patients will continue the study for an additional period of 2 weeks using only Chlorhexidine mouthwash and placebo gel (without ingredients) without tooth brushing. A new test with OralDNALabs with subsequent periodontal charting will be performed and a prophylaxis visit will be included at the end of the study.

The Group 2 (control)-patients will follow similar protocol starting with use of 0.12% Chlorhexidine (Peridex®) 3x/day as mouthwash for (1-2min) and a placebo control gel (without ingredients) for a period of 2 weeks and then the subjects will start using the StellaLife mouthwash and test gel for 2 weeks (crossover study). Also, the subjects must avoid eating or drinking for 15 min. after the use of the mouthwash and gel.

The GCF will be assessed utilizing the Periotron device at the times of periodontal charting to evaluate changes in volume of GCF (from one and the same site of each participant, one posterior tooth in the maxilla and one in the mandible), comparing the baseline, 2-week, and 4- week (final) visit. The same teeth will be used in all evaluation visits for each individual patient.

The professional cleaning will be performed at the end of the study by a certified dental hygienist to achieve low levels of plaque index and gingival index.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • Stony Brook, New York, United States, 11794
      • Stony Brook University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• healthy patients without periodontal disease

Exclusion Criteria:

• no pregnant women or patient with immunocompromised systemic diseases

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chlorhexidine	Drug: Chlorhexidine; Chlorhexidine in 2 different arms in an experimental gingivitis model
Experimental: StellaLife; StellaLife mouthwash for 2 weeks without tooth brushing	Drug: StellaLife; StellaLife will be used in an experimental gingivitis model

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probing pocket depth	probing pocket depth measurement (in mm)	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gingival crevicular fluid (GCF) volume	The measurement will be performed using the Periotron device (every 2 weeks in each group); from one and the same site of each participant, one posterior tooth in the maxilla and one in the mandible	4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Saliva analysis of bacteria	OralDNALabs test (Direct Diagnostics); determination of periodontal pathogens, such as A.a., P.g. T.d., T.f. and F.n.	4 weeks

Collaborators and Investigators

• Sponsor: Stony Brook University

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2023
• Primary Completion (Actual): April 19, 2023
• Study Completion (Actual): April 19, 2023

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: December 3, 2025
• First Posted (Actual): December 8, 2025

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Chlorhexidine; crossover study; experimental gingivitis; StellaLife
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Gingivitis; Organic Chemicals; Biguanides; Guanidines; Amidines; Chlorhexidine
• Other Study ID Numbers: IRB2022-00048

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes