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

NCT04865952 | Completed

• 1 other identifier: 5315 Prot 0640/2020
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the present study is to evaluate the effect of Hyaluronic acid application in the gene expression profile and cellular behavior in the early wound healing process -24 hours after injury- of the oral soft tissues.

Conditions

Wound Heal; Wound Surgical; Oral Soft Tissue Conditions; Hyaluronic Acid

Keywords

early wound healing; gingival tissue; wound healing; hyaluronic acid; soft tissue injury

Outcome Measures

Primary Outcomes (2)

• Changes from baseline fold regulation wound healing related genes at 24 hours HA application

  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.

  24 hours after surgery (T24 hours)

• 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.

  24 hours after surgery (T24 hours)

Study Arms (2)

HA application (treatment group - HA)

EXPERIMENTAL

periodontal surgery + HA application + buccal attached gingival (G) biopsies 24 hr after surgical procedure

Procedure: periodontal surgery + 24 hr buccal attached gingiva (G) biopsy; Other: HA application

NO HA application (non treatment group - NT)

OTHER

periodontal surgery + buccal attached gingival (G) biopsies 24 hr after surgical procedure

Procedure: periodontal surgery + 24 hr buccal attached gingiva (G) biopsy

Interventions

periodontal surgery + 24 hr buccal attached gingiva (G) biopsy PROCEDURE

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).

HA application (treatment group - HA); NO HA application (non treatment group - NT)

HA application OTHER

HA will be applied at the end of the surgical procedure, at the level of the vertical released incisions (VRIs) and over VRIs

HA application (treatment group - HA)

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• 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

Roma, 00161, Italy

Location

Related Publications (13)

• 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

• 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

• 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

• 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 BACKGROUND

• Bansal J, Kedige SD, Anand S. Hyaluronic acid: a promising mediator for periodontal regeneration. Indian J Dent Res. 2010 Oct-Dec;21(4):575-8. doi: 10.4103/0970-9290.74232.

  PMID: 21187628 BACKGROUND

• West DC, Hampson IN, Arnold F, Kumar S. Angiogenesis induced by degradation products of hyaluronic acid. Science. 1985 Jun 14;228(4705):1324-6. doi: 10.1126/science.2408340.

  PMID: 2408340 BACKGROUND

• Pilloni A, Bernard GW. The effect of hyaluronan on mouse intramembranous osteogenesis in vitro. Cell Tissue Res. 1998 Nov;294(2):323-33. doi: 10.1007/s004410051182.

  PMID: 9799448 BACKGROUND

• Fujioka-Kobayashi M, Muller HD, Mueller A, Lussi A, Sculean A, Schmidlin PR, Miron RJ. In vitro effects of hyaluronic acid on human periodontal ligament cells. BMC Oral Health. 2017 Jan 16;17(1):44. doi: 10.1186/s12903-017-0341-1.

  PMID: 28093072 BACKGROUND

• Nyman E, Henricson J, Ghafouri B, Anderson CD, Kratz G. Hyaluronic Acid Accelerates Re-epithelialization and Alters Protein Expression in a Human Wound Model. Plast Reconstr Surg Glob Open. 2019 May 1;7(5):e2221. doi: 10.1097/GOX.0000000000002221. eCollection 2019 May.

  PMID: 31333952 BACKGROUND

• Asparuhova MB, Kiryak D, Eliezer M, Mihov D, Sculean A. Activity of two hyaluronan preparations on primary human oral fibroblasts. J Periodontal Res. 2019 Feb;54(1):33-45. doi: 10.1111/jre.12602. Epub 2018 Sep 27.

  PMID: 30264516 BACKGROUND

MeSH Terms

Conditions

Surgical Wound; Soft Tissue Injuries

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Andrea Pilloni, MD,DDS,MS

  University of Roma La Sapienza

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman Section of Periodontics Director of Master Program in Periodontics

Model Details: split-mouth design

Study Record Dates

• First Submitted: April 25, 2021
• First Posted: April 29, 2021
• Study Start: April 29, 2021
• Primary Completion: July 5, 2021
• Study Completion: July 6, 2021
• Last Updated: October 4, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)