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Not yet recruitingNCT07669636Updated Jun 25, 2026

Effects of Chlorhexidine on Human Gingival Fibroblasts

An observational study in HGF, Fibroblast and Chlorhexidine, sponsored by IRCCS San Raffaele. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-25.

Sponsored by IRCCS San Raffaele · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
3
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • HGF
  • Fibroblast
  • Chlorhexidine
  • Cytotoxicity
  • Biocompatibility
03

In context

Lead sponsor

IRCCS San Raffaele is the lead sponsor of 443 studies on the registry; 234 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

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.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Presence of systemic diseases.
  • Presence of relevant medical comorbidities.
  • Current smoker.
  • Refusal to provide informed consent for the use of discarded biological material.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
3 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Healthy Adult Donors

    Human Gingival Fibroblast Cultures

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 24 hours, 3 days and 7 days from the start of cell culture exposure

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07669636
Lead sponsor
IRCCS San Raffaele
Responsible party
Rotundo Roberto (Associate Professor, IRCCS San Raffaele) — Principal investigator
First posted
Jun 25, 2026
Start date
Jul 1, 2026 (estimated)
Primary completion
Oct 1, 2026 (estimated)
Completion
Nov 1, 2026 (estimated)
Last update
Jun 25, 2026

Study contacts

Roberto Professor Roberto Rotundo, Associate Professor
Contact
rotundo.roberto@hsr.it
0226432643
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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