GingivitisPhase 4NCT07270952
Protocol Efficacy of Mouthwashes in Experimental Gingivitis
A Phase 4 study testing StellaLife and Chlorhexidine in people with Gingivitis, run by Stony Brook University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis
- What is being tested?
- StellaLife and Chlorhexidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2023to 19 Apr 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy patients without periodontal disease
Who cannot join
- no pregnant women or patient with immunocompromised systemic diseases
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Gingivitis
- Being tested
- StellaLife, Chlorhexidine
- Keywords
- experimental gingivitis, StellaLife, crossover study, Chlorhexidine
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StellaLifeDrug
StellaLife will be used in an experimental gingivitis model
ChlorhexidineDrug
Chlorhexidine in 2 different arms in an experimental gingivitis model
| Study group | Role | What they receive |
|---|---|---|
| StellaLife | Experimental | StellaLife mouthwash for 2 weeks without tooth brushing Receives: Drug: StellaLife |
| Chlorhexidine | Experimental | Not described Receives: Drug: Chlorhexidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing pocket depth
probing pocket depth measurement (in mm)
Measured: 4 weeks
Secondary outcomes (1)
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
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start11 Jan 2023
- Primary completion19 Apr 2023
- Study completion19 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georgios E. Romanos, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07270952
- Sponsor's protocol ID
- IRB2022-00048
- Status last verified
- Dec 2025
- First submitted
- 19 Nov 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol Efficacy of Mouthwashes in Experimental Gingivitis
- ClinicalTrials.gov ID
- NCT07270952
- Acronym / sponsor ID
- IRB2022-00048
- Conditions
- Gingivitis
- Keywords
- experimental gingivitis, StellaLife, crossover study, Chlorhexidine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- 11 Jan 2023 (actual)
- Primary completion
- 19 Apr 2023 (actual)
- Study completion
- 19 Apr 2023 (actual)
- First posted
- 8 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| StellaLife | Experimental | Drug: StellaLifeStellaLife mouthwash for 2 weeks without tooth brushing |
| Chlorhexidine | Experimental | Drug: Chlorhexidine |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy patients without periodontal disease
Key exclusion criteria (1 listed)
- no pregnant women or patient with immunocompromised systemic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StellaLifeStellaLife will be used in an experimental gingivitis model | Drug | StellaLife |
| ChlorhexidineChlorhexidine in 2 different arms in an experimental gingivitis model | Drug | Chlorhexidine |
Primary outcome
Probing pocket depth
Time frame: 4 weeks
probing pocket depth measurement (in mm)
1 secondary outcome
Gingival crevicular fluid (GCF) volume
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing StellaLife and Chlorhexidine in people with Gingivitis, run by Stony Brook University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing pocket depth (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.