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

NCT04276129 | Completed

• 1 other identifier: 5315 Prot 1066/19
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Wound Heal; Wound Surgical; Oral Soft Tissue Conditions; Chlorhexidine Adverse Reaction

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Changes from baseline fold regulation wound healing related genes at 24 hours after post-surgical chlorhexidine use.

  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)

Secondary Outcomes (1)

• Clinical evaluation of early wound healing

  24 hours after surgery (T24)

Study Arms (2)

post-surgical CHX mouth-rinses (treatment group - CHX)

EXPERIMENTAL

periodontal surgery + post-surgical CHX mouth-rinses + buccal attached gingival (G) biopsies 24 hr after surgical procedure

Procedure: periodontal surgery + 24 hr buccal attached gingiva (G) biopsy; Other: post-surgical CHX mouth-rinses indication

NO post-surgical mouth-rinses treatment (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).

NO post-surgical mouth-rinses treatment (non treatment group - NT); post-surgical CHX mouth-rinses (treatment group - CHX)

post-surgical CHX mouth-rinses indication OTHER

CHX mouth-rinses (0.12%) will be indicated 2 times/day after the surgical procedure

post-surgical CHX mouth-rinses (treatment group - CHX)

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

Roma, 00161, Italy

Location

Related Publications (10)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• Bassetti C, Kallenberger A. Influence of chlorhexidine rinsing on the healing of oral mucosa and osseous lesions. J Clin Periodontol. 1980 Dec;7(6):443-56. doi: 10.1111/j.1600-051x.1980.tb02151.x.

  PMID: 6938525 RESULT

• Faria G, Cardoso CR, Larson RE, Silva JS, Rossi MA. Chlorhexidine-induced apoptosis or necrosis in L929 fibroblasts: A role for endoplasmic reticulum stress. Toxicol Appl Pharmacol. 2009 Jan 15;234(2):256-65. doi: 10.1016/j.taap.2008.10.012. Epub 2008 Nov 6.

  PMID: 19027770 RESULT

• Mariotti AJ, Rumpf DA. Chlorhexidine-induced changes to human gingival fibroblast collagen and non-collagen protein production. J Periodontol. 1999 Dec;70(12):1443-8. doi: 10.1902/jop.1999.70.12.1443.

  PMID: 10632519 RESULT

MeSH Terms

Conditions

Surgical Wound

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: SINGLE
• Who Masked: 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

Study Record Dates

• First Submitted: February 16, 2020
• First Posted: February 19, 2020
• Study Start: February 20, 2020
• Primary Completion: October 17, 2020
• Study Completion: October 17, 2020
• Last Updated: March 1, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)