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

NCT04202822 | Completed

• 1 other identifier: 5315 Prot 2018/19
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Wound Surgical; Wound Heal; Oral Soft Tissue Conditions

Keywords

real-time polymerase chain reaction; early wound healing; gingiva; oral mucosa

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (T0) and 24 hours after surgery (T24)

Secondary Outcomes (1)

• Clinical evaluation of early wound healing

  24 hours and 1 week after surgery

Study Arms (1)

Biopsies

OTHER

Oral soft tissues biopsies (alveolar mucosa, buccal gingiva, and palatal tissue) at T0 and T24

Other: Oral soft tissues biopsies

Interventions

Oral soft tissues biopsies OTHER

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.

Biopsies

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

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

Rome, 00161, Italy

Location

Related Publications (14)

• Eming SA, Martin P, Tomic-Canic M. Wound repair and regeneration: mechanisms, signaling, and translation. Sci Transl Med. 2014 Dec 3;6(265):265sr6. doi: 10.1126/scitranslmed.3009337.

  PMID: 25473038 BACKGROUND

• Bartold PM, McCulloch CA, Narayanan AS, Pitaru S. Tissue engineering: a new paradigm for periodontal regeneration based on molecular and cell biology. Periodontol 2000. 2000 Oct;24:253-69. doi: 10.1034/j.1600-0757.2000.2240113.x. No abstract available.

  PMID: 11276871 BACKGROUND

• Szpaderska AM, Walsh CG, Steinberg MJ, DiPietro LA. Distinct patterns of angiogenesis in oral and skin wounds. J Dent Res. 2005 Apr;84(4):309-14. doi: 10.1177/154405910508400403.

  PMID: 15790734 BACKGROUND

• Warburton G, Nares S, Angelov N, Brahim JS, Dionne RA, Wahl SM. Transcriptional events in a clinical model of oral mucosal tissue injury and repair. Wound Repair Regen. 2005 Jan-Feb;13(1):19-26. doi: 10.1111/j.1067-1927.2005.130104.x.

  PMID: 15659033 BACKGROUND

• Wong JW, Gallant-Behm C, Wiebe C, Mak K, Hart DA, Larjava H, Hakkinen L. Wound healing in oral mucosa results in reduced scar formation as compared with skin: evidence from the red Duroc pig model and humans. Wound Repair Regen. 2009 Sep-Oct;17(5):717-29. doi: 10.1111/j.1524-475X.2009.00531.x.

  PMID: 19769724 BACKGROUND

• Mak K, Manji A, Gallant-Behm C, Wiebe C, Hart DA, Larjava H, Hakkinen L. Scarless healing of oral mucosa is characterized by faster resolution of inflammation and control of myofibroblast action compared to skin wounds in the red Duroc pig model. J Dermatol Sci. 2009 Dec;56(3):168-80. doi: 10.1016/j.jdermsci.2009.09.005. Epub 2009 Oct 24.

  PMID: 19854029 BACKGROUND

• Roy S, Khanna S, Rink C, Biswas S, Sen CK. Characterization of the acute temporal changes in excisional murine cutaneous wound inflammation by screening of the wound-edge transcriptome. Physiol Genomics. 2008 Jul 15;34(2):162-84. doi: 10.1152/physiolgenomics.00045.2008. Epub 2008 May 6.

  PMID: 18460641 BACKGROUND

• Chen W, Fu X, Ge S, Sun T, Zhou G, Han B, Li H, Sheng Z. Profiling of genes differentially expressed in a rat of early and later gestational ages with high-density oligonucleotide DNA array. Wound Repair Regen. 2007 Jan-Feb;15(1):147-55. doi: 10.1111/j.1524-475X.2006.00195.x.

  PMID: 17244330 BACKGROUND

• Iglesias-Bartolome R, Uchiyama A, Molinolo AA, Abusleme L, Brooks SR, Callejas-Valera JL, Edwards D, Doci C, Asselin-Labat ML, Onaitis MW, Moutsopoulos NM, Gutkind JS, Morasso MI. Transcriptional signature primes human oral mucosa for rapid wound healing. Sci Transl Med. 2018 Jul 25;10(451):eaap8798. doi: 10.1126/scitranslmed.aap8798.

  PMID: 30045979 BACKGROUND

• Wang Y, Tatakis DN. Human gingiva transcriptome during wound healing. J Clin Periodontol. 2017 Apr;44(4):394-402. doi: 10.1111/jcpe.12669. Epub 2017 Feb 11.

  PMID: 28005267 BACKGROUND

• Kantarci A, Black SA, Xydas CE, Murawel P, Uchida Y, Yucekal-Tuncer B, Atilla G, Emingil G, Uzel MI, Lee A, Firatli E, Sheff M, Hasturk H, Van Dyke TE, Trackman PC. Epithelial and connective tissue cell CTGF/CCN2 expression in gingival fibrosis. J Pathol. 2006 Sep;210(1):59-66. doi: 10.1002/path.2000.

  PMID: 16841303 BACKGROUND

• Vescarelli E, Pilloni A, Dominici F, Pontecorvi P, Angeloni A, Polimeni A, Ceccarelli S, Marchese C. Autophagy activation is required for myofibroblast differentiation during healing of oral mucosa. J Clin Periodontol. 2017 Oct;44(10):1039-1050. doi: 10.1111/jcpe.12767. Epub 2017 Aug 25.

  PMID: 28646601 BACKGROUND

• Marini L, Rojas MA, Sahrmann P, Aghazada R, Pilloni A. Early Wound Healing Score: a system to evaluate the early healing of periodontal soft tissue wounds. J Periodontal Implant Sci. 2018 Oct 24;48(5):274-283. doi: 10.5051/jpis.2018.48.5.274. eCollection 2018 Oct.

  PMID: 30405935 BACKGROUND

• Rojas MA, Ceccarelli S, Gerini G, Vescarelli E, Marini L, Marchese C, Pilloni A. Gene expression profiles of oral soft tissue-derived fibroblast from healing wounds: correlation with clinical outcome, autophagy activation and fibrotic markers expression. J Clin Periodontol. 2021 May;48(5):705-720. doi: 10.1111/jcpe.13439. Epub 2021 Feb 17.

  PMID: 33527447 DERIVED

MeSH Terms

Conditions

Surgical Wound

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Andrea Pilloni, MD,DDS,MS

  University of Roma La Sapienza

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman Section of Periodontics Director of Master Program in Periodontics

Study Record Dates

• First Submitted: December 13, 2019
• First Posted: December 18, 2019
• Study Start: April 1, 2019
• Primary Completion: June 6, 2019
• Study Completion: June 13, 2019
• Last Updated: February 19, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)