Clinical Research Directory

Effects of Chlorhexidine on Human Gingival Fibroblasts

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.

ORAL-PROTECT I: Oral Asepsis Preventing Transmission During Intubation

Postoperative respiratory complications, such as bacterial pneumonia, are common and serious problems after general anesthesia. They can lead to longer hospital stays, more complications, and increased mortality. One possible cause is that bacteria from the mouth and throat enter the lower airways during tracheal intubation. The mouth and throat naturally contain many bacteria, including potentially harmful microorganisms. During general anesthesia, coughing and swallowing reflexes are reduced or absent. When a tracheal tube is inserted, secretions from the mouth and throat may be carried into the trachea. The tube may also support the movement of contaminated fluid into the lower airways. ORAL-PROTECT I is a prospective, randomized, controlled study. It investigates whether simple oral hygiene before surgery can reduce the transfer of bacteria into the trachea during airway management under general anesthesia. The study includes patients aged 60 years or older undergoing elective surgery under general anesthesia with tracheal intubation. Participants are randomly assigned to an intervention group or a control group. The intervention group performs oral hygiene immediately before anesthesia. This includes brushing the teeth and tongue for about 3 minutes, followed by rinsing and gargling for about 1 minute with a chlorhexidine antiseptic solution. The control group receives standard care without additional oral hygiene. Oral, pharyngeal, and tracheal swabs will be collected at predefined time points. The primary outcome is based on the perioperative tracheal bacterial load, sampled every 30 minutes and assessed at two hours after induction of anesthesia. The co-primary outcome is based on the oral bacterial load immediately before endotracheal intubation. Secondary outcomes include changes in oral and tracheal bacterial load over time and identification of the microorganisms detected. The study aims to clarify early bacterial transfer during airway management and to evaluate whether a simple preoperative oral hygiene measure can reduce this process.

Salivary Microbiota and Antimicrobial Resistance in Relation to Chlorhexidine Use

This study evaluated the ecological effects of 0.06% chlorhexidine toothpaste on the salivary microbiota of healthy individuals, focusing on taxonomic composition, functional shifts, and prevalence of predicted antimicrobial resistance genes. Saliva samples were collected from eleven healthy participants at three specific time points: baseline (following a 4-week run-in period using a control toothpaste), intervention (after 12 weeks of using 0.06% chlorhexidine digluconate toothpaste), and washout (after a subsequent 12-week period using the control toothpaste). Sequencing targeted the 16S rRNA V3-V4 region.

Chlorhexidine Gluconate Versus Saline for Flushing the Surgical Area During Colorectal Cancer Surgery

The aim of this study was to compare the effectiveness of chlorhexidine versus saline in flushing the surgical area during colorectal cancer surgery. The primary outcomes included surgical site infection, postoperative complication rates, et al.

Evaluation of the Anti-Plaque Effect of a Resveratrol-Based Mouthwash Using a 24-Hour Plaque Re-Growth

Dental plaque is a biofilm that accumulates on tooth surfaces and is a primary factor in the development of gingival inflammation. While toothbrushing remains the main method for plaque control, the effectiveness of mechanical oral hygiene depends largely on individual compliance and technique. As a result, mouthwashes are commonly used as adjunctive chemical plaque control agents. Chlorhexidine gluconate is an effective anti-plaque mouthwash, but its use is associated with undesirable effects that may limit patient acceptance. Resveratrol is a naturally derived compound with reported antimicrobial and anti-biofilm properties, suggesting its potential use as an alternative chemical plaque control agent. This randomized, double-blind, placebo-controlled, three-period crossover clinical trial aims to evaluate the short-term anti-plaque effect of a resveratrol-based mouthwash by measuring supragingival plaque regrowth over a 24-hour period in periodontally healthy individuals. The effects of the resveratrol-based mouthwash will be compared with 0.12% chlorhexidine (CHX) and a placebo mouthwash under standardized conditions without mechanical oral hygiene

Perioperative Respiratory Care and Outcomes for Patients Undergoing High Risk Abdominal Surgery

PENGUIN is a pragmatic multi-center trial investigating the effects of pre-operative mouthwash and perioperative oxygen on the incidences of pneumonia and surgical site infection (SSI) following major abdominal surgery. Patients will be recruited from low and middle income countries and randomly assigned to a trial treatment arms: a) pre-operative chlorhexidine mouthwash and 80-100% FiO2; b) no pre-operative mouthwash and 80-100% fraction of inspired oxygen (FiO2); c) pre-operative chlorhexidine mouthwash and 21- 30% FiO2; or d) no pre-operative mouthwash and 21-30% FiO2.