NCT04276129

Early Healing of Oral Soft Tissues: a Clinical and Biomolecular Analysis. Part II

Early Healing of Oral Soft Tissues: a Clinical and Biomolecular Analysis. Part II - Effect of Local Chlorhexidine Administration in Gene Expression and Cellular Behaviour 24-hours After Injury

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: University of Roma La Sapienza · Academic / Other
• Sex: All
• Age: 30 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the present study is to evaluate the influence of the post-surgical chlorhexidine indication in the gene expression profile and cellular behavior in the early wound healing process -24 hours after injury- of the oral soft tissues. The main hypothesis is that the post-surgical use of chlorhexidine affects the gene expression and the celular behavior in the early wound healing process of the soft oral tissues.

Detailed description

The bacterial infection control in the wound healing is a very important aspect to considerer. Local antiseptic administration after the surgical procedures has been used to control the bacterial contamination. Chlorhexidine (CHX), widely used as antiseptic, especially as post-surgical indication, has a toxic effect both in vivo and in vitro and their influence on wound healing has been studied for a long time. One of the first animal studies, in 1980, concluded that intensive rinsing with high concentrations of chlorhexidine after oral surgical operations, could result in delay and disturbance of wound healing. Another more recent animal study concluded that CHX induces apoptosis or necrosis in the fibroblasts. Mariotti and Rumpf, in 2016, carried out a studied incubating human gingival fibroblasts in CHX. The results have been suggested that chlorhexidine could induce a dose dependent reduction in cellular proliferation and that concentrations of chlorhexidine that have little effect on cellular proliferation can significantly reduce both collagen and non-collagen protein production of human gingival fibroblasts in vitro. Hence, the introduction of commercially available concentrations (0.12%) or diluted commercial concentrations (as low as 0.00009%) of chlorhexidine to surgical sites for short periods of time prior to wound closure can conceivably have serious toxic effects on gingival fibroblasts and may negatively affect wound healing. All the previous mentioned studies permit understand that the CHX is not harmless to the oral tissues. However, its effect is not entirely clear and should be evaluated in depth taking into account that it is one of the most indicated antiseptics after surgery. Currently, there are no studies that evaluate if the post-surgical use of CHX affect the gene expression in the early wound healing.

Conditions

• Wound Heal
• Wound Surgical
• Oral Soft Tissue Conditions
• Chlorhexidine Adverse Reaction

Interventions

Type	Name	Description
PROCEDURE	periodontal surgery + 24 hr buccal attached gingiva (G) biopsy	Periodontal surgery will be performed and 24 hr after the surgical procedure a 2mm punch biopsy will be harvested at the level of the buccal attache gingiva (G).
OTHER	post-surgical CHX mouth-rinses indication	CHX mouth-rinses (0.12%) will be indicated 2 times/day after the surgical procedure

Timeline

• Start date: 2020-02-20
• Primary completion: 2020-10-17
• Completion: 2020-10-17
• First posted: 2020-02-19
• Last updated: 2021-03-01

Locations

1 site across 1 country: Italy