Genotoxicity Assessment of Dental Implants in Gingival Epithelial Cells
NCT ID: NCT04540991
Last Updated: 2020-09-07
Study Results
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Basic Information
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UNKNOWN
PHASE3
80 participants
INTERVENTIONAL
2020-03-10
2022-04-25
Brief Summary
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Exfoliated gingival cells will be taken from 80 participants before and after 90 days of dental implant insertion, and 21 days following gingiva former placement. DNA damage will be analyzed using the micronucleus test. Tested dental implants will be Ankylos and Dentium, with corresponding gingival former.
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Detailed Description
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The implants are placed in accordance with each implant system manufacturer's instructions and the treatment were performed according to the patient's standards and indications. Surgical procedures on all patients are performed by the same operator with the same surgical approach, protocol and instrumentation.
The surgeries are performed under local anesthesia and systemic antibiotics were given according to standard procedure. To ensure post-surgical oral hygiene, patients are advised to rinse the oral cavity with chlorhexidine until the day of sutures' removal. The sutures are removed10 day after implantation. The implants are healing by being submerged for 12 weeks based on the surgeon's clinical judgment, indications given and the need and preference of the patients. After healing, gingiva formers are placed.
Sample collection and a micronucleus assay in gingival epithelial cells To reduce individual variations, patients are observed longitudinally and each subject is served as their own control. Samples of gingival epithelial cells are collected from each participant's implementation site using the swab technique at three different time points: a control swab is taken just before the placement of the dental implant (T0); the second swab is taken 90 days after implantation meaning immediately before placement of the gingiva former (T1); and the third swab is taken 21 days after placement of the gingiva former (T2).
One hour before the sampling, the participants abstain from consuming any food and drinks. After rinsing of the oral cavity 3 times with tepid water to remove exfoliated cells, a T0 swab is taken by gently brushing the gingiva around place indicated for implant placement and later T1 and T2 around implant with a cytobrush (Cytobrush Plus; GmbH. Dietramszell-Linden, Germany). The samples are subsequently applied to coded laboratory glass slides.
The cells applied to microscopic slides are allowed to air-dry and fixed in methanol (80% v/v) at 4°C for 20 minutes. Staining is conducted with 5% Giemsa solution for 10 minutes. Afterward, the slides are rinsed with aqua distillate and air dry. The slides are examined under Olympus CX40 light microscope (Olympus. Tokyo. Japan) with 400× magnification, and each micronucleus and other nuclear anomalies are additionally verified under 1000× magnification. Two replicate slides are prepared for each subject and 1000 epithelium cells per preparation were analyzed for each sampling time.
Nuclear anomalies, such as micronucleus, karyorrhexis (nuclear disintegration indicating apoptosis), karyolysis (dissolution of the nucleus mostly indicating necrosis and apoptosis), pyknosis (nuclear shrinkage due to apoptosis), condensed chromatin (DNA complexed with proteins and apoptosis), nuclear buds (precursors of micronuclei, or high density of DNA repair complexes) and broken eggs (nuclei that appear cinched, binucleated cells (indicating impaired velocity of cell proliferation)) are estimated and qualified.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
DOUBLE
Study Groups
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Ankylos dental implant group
Patients are divided into two groups depending on the dental implant system used in the therapy. Ankylos dental implants (Dentsplay Sirona, Charlotte, USA) areused in the first group of patients.
implant placement
The implants are placed in accordance with each implant system manufacturer's instructions and the treatment were performed according to the patient's standards and indications. Surgical procedures on all patients are performed by the same operator with the same surgical approach, protocol and instrumentation.
gingiva former placement
Gingiva former are placed in accordance with each implant system manufacturer's instructions and the treatment were performed according to the patient's standards and indications. Surgical procedures of oppeninf implant cower and gingiva former placement on all patients are performed by the same operator with the same surgical approach, protocol and instrumentation.
Collecting gingival epithelial cellsusing the swab technique
Samples of gingival epithelial cells are collected from each participant's implementation site using the swab technique at three different time points: a control swab is taken just before the placement of the dental implant (T0); the second swab is taken 90 days after implantation meaning immediately before placement of the gingiva former (T1); and the third swab is taken 21 days after placement of the gingiva former (T2).
Dentium SuperLine implant group
Patients are divided into two groups depending on the dental implant system used in the therapy. Dentium SuperLine implants (Dentium Co., Seoul, Korea) is used in the second group of patients-.
implant placement
The implants are placed in accordance with each implant system manufacturer's instructions and the treatment were performed according to the patient's standards and indications. Surgical procedures on all patients are performed by the same operator with the same surgical approach, protocol and instrumentation.
gingiva former placement
Gingiva former are placed in accordance with each implant system manufacturer's instructions and the treatment were performed according to the patient's standards and indications. Surgical procedures of oppeninf implant cower and gingiva former placement on all patients are performed by the same operator with the same surgical approach, protocol and instrumentation.
Collecting gingival epithelial cellsusing the swab technique
Samples of gingival epithelial cells are collected from each participant's implementation site using the swab technique at three different time points: a control swab is taken just before the placement of the dental implant (T0); the second swab is taken 90 days after implantation meaning immediately before placement of the gingiva former (T1); and the third swab is taken 21 days after placement of the gingiva former (T2).
Interventions
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implant placement
The implants are placed in accordance with each implant system manufacturer's instructions and the treatment were performed according to the patient's standards and indications. Surgical procedures on all patients are performed by the same operator with the same surgical approach, protocol and instrumentation.
gingiva former placement
Gingiva former are placed in accordance with each implant system manufacturer's instructions and the treatment were performed according to the patient's standards and indications. Surgical procedures of oppeninf implant cower and gingiva former placement on all patients are performed by the same operator with the same surgical approach, protocol and instrumentation.
Collecting gingival epithelial cellsusing the swab technique
Samples of gingival epithelial cells are collected from each participant's implementation site using the swab technique at three different time points: a control swab is taken just before the placement of the dental implant (T0); the second swab is taken 90 days after implantation meaning immediately before placement of the gingiva former (T1); and the third swab is taken 21 days after placement of the gingiva former (T2).
Eligibility Criteria
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Inclusion Criteria
* belonging to ASA I or ASA II group
* absence of titanium hypersensitivity
* absence of prosthetic restoration/replacement or orthodontic appliances in the oral cavity, -absence of oral precancerous lesions
* no history of radiation in the head and neck area
* absence of bisphosphonates and corticosteroids used in therapy.
Exclusion Criteria
* pocket depths ≥ 4 mm on adjacent teeth
* bruxism
* poor oral hygiene
* pregnant and lactating women
* taking of antibiotics in the last three months
* taking any other pharmaceutics that have been proved to elevate DNA damage,
* underwent medical radiation diagnostics
* using mouthwash that contain alcohol
* history of radiation in the head and neck area.
18 Years
ALL
Yes
Sponsors
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Daniel Jerković
OTHER
Responsible Party
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Daniel Jerković
DMD
Principal Investigators
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Daniel Jerkovic, DMD
Role: PRINCIPAL_INVESTIGATOR
University of Split, School of Medicine
Locations
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School of Medicine, University of Split
Split, , Croatia
Countries
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References
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Berglund F, Carlmark B. Titanium, sinusitis, and the yellow nail syndrome. Biol Trace Elem Res. 2011 Oct;143(1):1-7. doi: 10.1007/s12011-010-8828-5. Epub 2010 Sep 1.
Sidambe AT. Biocompatibility of Advanced Manufactured Titanium Implants-A Review. Materials (Basel). 2014 Dec 19;7(12):8168-8188. doi: 10.3390/ma7128168.
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Camacho-Alonso F, Sanchez-Siles M, Gilbel-del Aguila O. No Evidence of Genotoxic Damage in a Group of Patients with Titanium Dental Implants and Different Metal Restorations in the Oral Cavity. Clin Implant Dent Relat Res. 2015 Aug;17(4):811-21. doi: 10.1111/cid.12163. Epub 2013 Oct 17.
Karahalil B, Kadioglu E, Tuzuner-Oncul AM, Cimen E, Emerce E, Kisnisci RS. Micronucleus assay assessment of possible genotoxic effects in patients treated with titanium alloy endosseous implants or miniplates. Mutat Res Genet Toxicol Environ Mutagen. 2014 Jan 15;760:70-2. doi: 10.1016/j.mrgentox.2013.10.005. Epub 2013 Nov 1.
de Barros Lucena GA, de Molon RS, Moretti AJ, Shibli JA, Rego DM. Evaluation of Microbial Contamination in the Inner Surface of Titanium Implants Before Healing Abutment Connection: A Prospective Clinical Trial. Int J Oral Maxillofac Implants. 2018 Jul/Aug;33(4):853-862. doi: 10.11607/jomi.5817.
Makihira S, Mine Y, Nikawa H, Shuto T, Iwata S, Hosokawa R, Kamoi K, Okazaki S, Yamaguchi Y. Titanium ion induces necrosis and sensitivity to lipopolysaccharide in gingival epithelial-like cells. Toxicol In Vitro. 2010 Oct;24(7):1905-10. doi: 10.1016/j.tiv.2010.07.023. Epub 2010 Aug 1.
Harris BH, Kohles SS. Effects of mechanical and thermal fatigue on dental drill performance. Int J Oral Maxillofac Implants. 2001 Nov-Dec;16(6):819-26.
Souza JCM, Henriques M, Teughels W, Ponthiaux P, Celis JP, Rocha LA. Wear and corrosion interactions on titanium in oral environment: literature review. J Bio Tribo Corros. 2015;1:1-13.
Broggini N, McManus LM, Hermann JS, Medina R, Schenk RK, Buser D, Cochran DL. Peri-implant inflammation defined by the implant-abutment interface. J Dent Res. 2006 May;85(5):473-8. doi: 10.1177/154405910608500515.
Superline | Products | Dentium [Internet]. Dentiumusa.com. 2020 [citirano 21.6.2020.]. Dostupno na: http://dentiumusa.com/products/dentalimplant/superline.htm
Ankylos | Dentsply Sirona [Internet]. Dentsplysirona.com. 2020 [citirano 21.6.2020]. Dostupno na: https://www.dentsplysirona.com/enus/categories/implantology/ankylos.html
Thomas P, Holland N, Bolognesi C, Kirsch-Volders M, Bonassi S, Zeiger E, Knasmueller S, Fenech M. Buccal micronucleus cytome assay. Nat Protoc. 2009;4(6):825-37. doi: 10.1038/nprot.2009.53. Epub 2009 May 7.
Holland N, Bolognesi C, Kirsch-Volders M, Bonassi S, Zeiger E, Knasmueller S, Fenech M. The micronucleus assay in human buccal cells as a tool for biomonitoring DNA damage: the HUMN project perspective on current status and knowledge gaps. Mutat Res. 2008 Jul-Aug;659(1-2):93-108. doi: 10.1016/j.mrrev.2008.03.007. Epub 2008 Apr 11.
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Other Identifiers
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003-08/20-03/0005
Identifier Type: -
Identifier Source: org_study_id
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