Effects of Chlorhexidine on Human Gingival Fibroblasts

June 20, 2026 updated by: Rotundo Roberto, IRCCS San Raffaele

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Roberto Professor Roberto Rotundo, Associate Professor
  • Phone Number: 0226432643
  • Email: rotundo.roberto@hsr.it

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Healthy Adult Donors
Human Gingival Fibroblast Cultures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours, 3 days and 7 days from the start of cell culture exposure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

June 20, 2026

First Submitted That Met QC Criteria

June 20, 2026

First Posted (Actual)

June 25, 2026

Study Record Updates

Last Update Posted (Actual)

June 25, 2026

Last Update Submitted That Met QC Criteria

June 20, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • Chx.01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cytotoxicity

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bangladesh

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe