An interventional study of Oral soft tissues biopsies in Wound Surgical, Wound Heal and Oral Soft Tissue Conditions, sponsored by University of Roma La Sapienza. Completed at 1 site in Italy. Open to participants aged 30 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-02-19.
Sponsored by University of Roma La Sapienza · Not applicable, Interventional, and Basic science
The purpose of the present study is to observe and compare -through a biomolecular analysis- the differences in the gene expression and cellular behavior in the early wound healing process -24 hours after injury- between the following three oral tissues: alveolar mucosa, buccal gingiva and palatal tissue.
The main hypothesis is that there is a difference in the gene expression and in the cellular behaviour between the three oral tissues studied and this difference can be observed at 24 hours post-injury.
The wound healing is an extremely complex process. It has been observed that oral wounds mechanisms present special features. In fact, mucosal wounds demonstrated accelerated healing compared to cutaneous wounds.
Numerous comparative studies have described important differences of cellular behavior and genes expression between oral mucosal and dermal tissues. Moreover, it has been observed that the behavior of the cells is autonomous, i.e., that greatest differences seen in the genomic response after injury in skin and mucosa are derived, in part, from intrinsic differences in the genetic regulation of the cells at each site. Also, it is important to highlight the fact that it has been observed that the cellular response after wound is early, showing the first and greatest changes at 12-24 hours post injury. Moreover, a recent study has been raised the possibility of that the transcriptional regulatory networks responsible for the accelerated healing in oral mucosa are already present in the unwounded state.
In the oral mucosal tissues, the mechanisms underlying scar-less wound healing have been studied. Most studies have focused on the cellular characteristics and the molecular expression as growing factors, inflammatory mediators, etc., and have evaluated the process in later periods.
Therefore, while the biomolecular basis of the differences in oral mucosal and dermal tissues wound healing have been described, this is less well understood in the different oral soft tissue wounds.
The following points must be considered:
The main questions are:
The transcriptional regulatory networks responsible for the accelerated oral tissues healing:
Deepen the knowledge in the early wound healing process of these tissues and the difference between them -evaluating the genes expression and the behavior of the cells- could allow the generation of new approaches to improve the healing of oral wounds.
5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.
This study's enrollment of 15 is below the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.
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Exclusion Criteria:
Oral soft tissues biopsies (alveolar mucosa, buccal gingiva, and palatal tissue) at T0 and T24
Other: Oral soft tissues biopsies
Oral soft tissues biopsies (alveolar mucosa, buccal gingiva, and palatal tissue) will be harvested by the examiner at the time of the surgery (immediately before to start the surgical procedure -T0) and 24 hours after surgery (T24) at the level of the vertical released incisions (VRIs) with a biopsy punch with plunger of 2.0 mm diameter.
Changes from baseline fold regulation wound healing related genes at 24 hours
Total RNA from biopsies or cell cultures was extracted using TRIzol reagent Quantitative real-time PCR (qRT-PCR) cDNA was generated and cDNA obtained were used for amplification of wound healing related genes using the appropriate TaqMan gene expression assay kits.
Time frame: Baseline (T0) and 24 hours after surgery (T24)
Clinical evaluation of early wound healing
Assessed with a clinical index (EHS- Early wound healing score). This score assessed clinical signs of re-epithelialization (CSR), clinical signs of haemostasis (CSH), and clinical signs of inflammation (CSI). Since complete wound epithelialization was the main outcome, the CSR score was weighted to be 60% of the total final score. Accordingly, a score of 0, 3, or 6 points was possible for the assessment of CSR, whereas scores of 0, 1, or 2 points were possible for CSH and CSI. Higher values indicated better healing. Accordingly, the score for ideal early wound healing was 10.
Time frame: 24 hours and 1 week after surgery
Plan to share: No
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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University of Roma La Sapienza