HGFNCT07669636
Effects of Chlorhexidine on Human Gingival Fibroblasts
An observational study of HGF and Fibroblast, run by IRCCS San Raffaele.
Trial summary
This prospective in vitro study aims to evaluate the effects of two chlorhexidine-based mouthwash formulations on the survival and function of human gingival fibroblasts (hGFs). Gingival fibroblasts obtained from discarded gingival tissue collected during routine dental procedures will be cultured and exposed to… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HGF, Fibroblast, Chlorhexidine
- How many people
- 3 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 1 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consists of three healthy adult donors undergoing routine dental surgical procedures at the Dental Unit of San Raffaele Hospital. Small fragments of discarded gingival tissue obtained during procedures such as tooth extraction or gingivectomy will be collected following informed consent. Human gingival fibroblasts will be isolated from these tissues and expanded in culture for in vitro experimental analyses.
Who may be able to join
- Male or female adults aged 18 years or older.
- Undergoing routine dental surgical procedures (e.g., tooth extraction or gingivectomy).
- Willing and able to provide written informed consent for the use of discarded gingival tissue for research purposes.
- Systemically healthy.
Who cannot join
- Presence of systemic diseases.
- Presence of relevant medical comorbidities.
- Current smoker.
- Refusal to provide informed consent for the use of discarded biological material.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: In Vitro Effects of a New Chlorhexidine-based Solution on Human Gingival Fibroblasts Survival and Function
This prospective in vitro study aims to evaluate the effects of two chlorhexidine-based mouthwash formulations on the survival and function of human gingival fibroblasts (hGFs). Gingival fibroblasts obtained from discarded gingival tissue collected during routine dental procedures will be cultured and exposed to different concentrations of a conventional 0.2% chlorhexidine mouthwash and a 0.2% chlorhexidine mouthwash supplemented with N-acetylcysteine (NAC) and hyaluronic acid (HA).
Cell viability, apoptosis, migration, and gene expression will be assessed at multiple time points using Trypan Blue exclusion assay, fluorescence-activated cell sorting (FACS), scratch assay, and quantitative real-time PCR. The study is designed to investigate the concentration-dependent effects of chlorhexidine on fibroblast viability and wound-healing-related functions and to determine whether the addition of NAC and HA may improve the biological compatibility of chlorhexidine-based formulations.
- Conditions
- HGF, Fibroblast, Chlorhexidine, Cytotoxicity, Biocompatibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Adult Donors | Human Gingival Fibroblast Cultures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Human Gingival Fibroblast Viability
Cell viability of human gingival fibroblast cultures exposed in vitro to different concentrations of chlorhexidine-based mouthwash formulations will be assessed using Trypan Blue exclusion assay and live/dead analysis by fluorescence-activated cell sorting (FACS). Viability will be expressed as the proportion of viable cells compared with total counted cells.
Measured: 24 hours, 3 days and 7 days from the start of cell culture exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HGFStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rotundo Roberto, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07669636
- Sponsor's protocol ID
- Chx.01
- Status last verified
- Jun 2026
- First submitted
- 20 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vitro Effects of a New Chlorhexidine-based Solution on Human Gingival Fibroblasts Survival and Function
- ClinicalTrials.gov ID
- NCT07669636
- Acronym / sponsor ID
- Chx.01
- Conditions
- HGF, Fibroblast, Chlorhexidine, Cytotoxicity, Biocompatibility
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 25 Jun 2026 (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 prospective in vitro study aims to evaluate the effects of two chlorhexidine-based mouthwash formulations on the survival and function of human gingival fibroblasts (hGFs). Gingival fibroblasts obtained from discarded gingival tissue collected during routine dental procedures will be cultured and exposed to different concentrations of a conventional 0.2% chlorhexidine mouthwash and a 0.2% chlorhexidine mouthwash supplemented with N-acetylcysteine (NAC) and hyaluronic acid (HA).
Cell viability, apoptosis, migration, and gene expression will be assessed at multiple time points using Trypan Blue exclusion assay, fluorescence-activated cell sorting (FACS), scratch assay, and quantitative real-time PCR. The study is designed to investigate the concentration-dependent effects of chlorhexidine on fibroblast viability and wound-healing-related functions and to determine whether the addition of NAC and HA may improve the biological compatibility of chlorhexidine-based formulations.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Adult Donors | – | –Human Gingival Fibroblast Cultures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of three healthy adult donors undergoing routine dental surgical procedures at the Dental Unit of San Raffaele Hospital. Small fragments of discarded gingival tissue obtained during procedures such as tooth extraction or gingivectomy will be collected following informed consent. Human gingival fibroblasts will be isolated from these tissues and expanded in culture for in vitro experimental analyses.
Key inclusion criteria (4 listed)
- Male or female adults aged 18 years or older.
- Undergoing routine dental surgical procedures (e.g., tooth extraction or gingivectomy).
- Willing and able to provide written informed consent for the use of discarded gingival tissue for research purposes.
- Systemically healthy.
Key exclusion criteria (4 listed)
- Presence of systemic diseases.
- Presence of relevant medical comorbidities.
- Current smoker.
- Refusal to provide informed consent for the use of discarded biological material.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Human Gingival Fibroblast Viability
Time frame: 24 hours, 3 days and 7 days from the start of cell culture exposure
Cell viability of human gingival fibroblast cultures exposed in vitro to different concentrations of chlorhexidine-based mouthwash formulations will be assessed using Trypan Blue exclusion assay and live/dead analysis by fluorescence-activated cell sorting (FACS). Viability will be expressed as the proportion of viable cells compared with total counted cells.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of HGF and Fibroblast, run by IRCCS San Raffaele.
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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roberto Professor Roberto Rotundo, Associate Professor (0226432643, rotundo.roberto@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Human Gingival Fibroblast Viability (time frame: 24 hours, 3 days and 7 days from the start of cell culture exposure). 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 25 Jun 2026.