Early Healing of Oral Soft Tissues: a Clinical and Biomolecular Analysis. Part II
Condition: Wound Heal; Wound Surgical; Oral Soft Tissue Conditions; Chlorhexidine Adverse Reaction
MeSH terms: Wounds and Injuries; Surgical Wound
Study type: Interventional

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.
    

Intervention name(s): periodontal surgery + 24 hr buccal attached gingiva (G) biopsy; post-surgical CHX mouth-rinses indication
Intervention type(s): Procedure; Other
Intervention description(s): 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).; CHX mouth-rinses (0.12%) will be indicated 2 times/day after the surgical procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: early wound healing; real-time polymerase chain reaction; gingiva; oral mucosa; palatal tissue; Chlorhexidine