Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

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

16 februari 2020 uppdaterad av: Andrea Pilloni MD DDS MS, University of Roma La Sapienza

Early Healing of Oral Soft Tissues: a Clinical and Biomolecular Analysis Part I - Gene Expression and Cellular Behaviour 24-hours After Injury

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.

Studieöversikt

Detaljerad beskrivning

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 differences in the wound healing between mucosal and dermal tissues have been extensively studied through biomolecular analysis.
  • The behavior of the cells is autonomous.
  • The changes in the wound healing have been observed after 12-24 hours post-injury.
  • The transcriptional regulatory networks responsible for the accelerated healing in oral mucosa could already be present in the unwounded state.
  • The differences in the wound healing between the different oral soft tissues (alveolar mucosa, buccal gingiva and palatal tissue) has not been studied from a biomolecular point of view; however, differences in the clinical behavior and response between these three oral tissues has been reported.

The main questions are:

  1. Twenty-four hours after injury: Are there differences in the gene expression and cellular behaviour between the three studied tissues?
  2. The transcriptional regulatory networks responsible for the accelerated oral tissues healing:

    • Are presents in the unwounded state?
    • Are differences between the three studied oral tissues?

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

15

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

      • Rome, Italien, 00161
        • Department of Oral and Maxillofacial Sciences. Section of Periodontics.Sapienza, University of Rome

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

30 år till 60 år (Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • patients that required periodontal surgery;
  • patients age between 30-60 years;
  • patients with full mouth plaque score and full mouth bleeding score < 15%;
  • patients with a good general healthy status;
  • patients without any medicaments or drug consumption that can affect the healing process;
  • non-smoking patients.

Exclusion Criteria:

  • patients in pregnancy;
  • patients in lactation period;
  • patients with consumption of antibiotics or anti-inflammatory drugs in the previous six months;
  • patients with systemic diseases.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Grundläggande vetenskap
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Övrig: Biopsies
Oral soft tissues biopsies (alveolar mucosa, buccal gingiva, and palatal tissue) at T0 and T24
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Changes from baseline fold regulation wound healing related genes at 24 hours
Tidsram: Baseline (T0) and 24 hours after surgery (T24)
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.
Baseline (T0) and 24 hours after surgery (T24)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Clinical evaluation of early wound healing
Tidsram: 24 hours and 1 week after surgery
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.
24 hours and 1 week after surgery

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 april 2019

Primärt slutförande (Faktisk)

6 juni 2019

Avslutad studie (Faktisk)

13 juni 2019

Studieregistreringsdatum

Först inskickad

13 december 2019

Först inskickad som uppfyllde QC-kriterierna

17 december 2019

Första postat (Faktisk)

18 december 2019

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

19 februari 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

16 februari 2020

Senast verifierad

1 februari 2020

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 5315 Prot 2018/19

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera