Early Healing of Oral Soft Tissues: a Clinical and Biomolecular Analysis. Part II
NCT ID: NCT04276129
Last Updated: 2021-03-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
3 participants
INTERVENTIONAL
2020-02-20
2020-10-17
Brief Summary
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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.
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Detailed Description
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Chlorhexidine (CHX), widely used as antiseptic, especially as post-surgical indication, has a toxic effect both in vivo and in vitro and their influence on wound healing has been studied for a long time. One of the first animal studies, in 1980, concluded that intensive rinsing with high concentrations of chlorhexidine after oral surgical operations, could result in delay and disturbance of wound healing. Another more recent animal study concluded that CHX induces apoptosis or necrosis in the fibroblasts.
Mariotti and Rumpf, in 2016, carried out a studied incubating human gingival fibroblasts in CHX. The results have been suggested that chlorhexidine could induce a dose dependent reduction in cellular proliferation and that concentrations of chlorhexidine that have little effect on cellular proliferation can significantly reduce both collagen and non-collagen protein production of human gingival fibroblasts in vitro. Hence, the introduction of commercially available concentrations (0.12%) or diluted commercial concentrations (as low as 0.00009%) of chlorhexidine to surgical sites for short periods of time prior to wound closure can conceivably have serious toxic effects on gingival fibroblasts and may negatively affect wound healing.
All the previous mentioned studies permit understand that the CHX is not harmless to the oral tissues. However, its effect is not entirely clear and should be evaluated in depth taking into account that it is one of the most indicated antiseptics after surgery. Currently, there are no studies that evaluate if the post-surgical use of CHX affect the gene expression in the early wound healing.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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post-surgical CHX mouth-rinses (treatment group - CHX)
periodontal surgery + post-surgical CHX mouth-rinses + buccal attached gingival (G) biopsies 24 hr after surgical procedure
periodontal surgery + 24 hr buccal attached gingiva (G) biopsy
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).
post-surgical CHX mouth-rinses indication
CHX mouth-rinses (0.12%) will be indicated 2 times/day after the surgical procedure
NO post-surgical mouth-rinses treatment (non treatment group - NT)
periodontal surgery + buccal attached gingival (G) biopsies 24 hr after surgical procedure
periodontal surgery + 24 hr buccal attached gingiva (G) biopsy
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).
Interventions
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periodontal surgery + 24 hr buccal attached gingiva (G) biopsy
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).
post-surgical CHX mouth-rinses indication
CHX mouth-rinses (0.12%) will be indicated 2 times/day after the surgical procedure
Eligibility Criteria
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Inclusion Criteria
* 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 lactation period;
* patients with consumption of antibiotics or anti-inflammatory drugs in the previous six months;
* patients with systemic diseases.
30 Years
60 Years
ALL
No
Sponsors
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University of Roma La Sapienza
OTHER
Responsible Party
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Andrea Pilloni MD DDS MS
Chairman Section of Periodontics Director of Master Program in Periodontics
Principal Investigators
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Andrea Pilloni, MD,DDS,MS
Role: STUDY_DIRECTOR
University of Roma La Sapienza
Locations
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Department of Oral and Maxillofacial Sciences. Section of Periodontics.Sapienza, University of Rome
Roma, , Italy
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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5315 Prot 1066/19
Identifier Type: -
Identifier Source: org_study_id
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