- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07669636
Effects of Chlorhexidine on Human Gingival Fibroblasts
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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Roberto Professor Roberto Rotundo, Associate Professor
- Telefonnummer: 0226432643
- E-mail: rotundo.roberto@hsr.it
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Healthy Adult Donors
Human Gingival Fibroblast Cultures
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Human Gingival Fibroblast Viability
Tidsramme: 24 hours, 3 days and 7 days from the start of cell culture exposure
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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.
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24 hours, 3 days and 7 days from the start of cell culture exposure
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- Chx.01
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