Effects of Chlorhexidine on Human Gingival Fibroblasts

In Vitro Effects of a New Chlorhexidine-based Solution on Human Gingival Fibroblasts Survival and Function

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07669636

Enrollment

Registered

2026-06-25

Start date

2026-07-01

Completion date

2026-11-01

Last updated

2026-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biocompatibility, Chlorhexidine, Cytotoxicity, Fibroblast, HGF

Brief 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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

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

Design outcomes

Primary

Measure	Time frame	Description
Human Gingival Fibroblast Viability	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.

Contacts

CONTACTRoberto Professor Roberto Rotundo, Associate Professor

rotundo.roberto@hsr.it0226432643

Outcome results