GenotoxicityPhase 3NCT04540991
Genotoxicity Assessment of Dental Implants in Gingival Epithelial Cells
A Phase 3 study testing implant placement, gingiva former placement and Collecting gingival epithelial cellsusing the swab technique in people with Genotoxicity, run by Daniel Jerković at 1 site in Croatia.
Trial summary
Due to the strong correlation between genotoxicity and carcinogenesis, it is necessary to clarify the potential genotoxic effects of titanium dental implant systems. As most dental materials release small amounts of several elements into the oral cavity, proper regulations have to guarantee that the concern from… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Genotoxicity
- What is being tested?
- implant placement, gingiva former placement and Collecting gingival epithelial cellsusing the swab technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCroatia
- Study dates
- 10 Mar 2020to 25 Apr 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- absence of a single tooth in the mandibular molar or premolar region
- 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.
Who cannot join
- presence of systemic disease (e.g. uncontrolled diabetes, oral mucosal diseases, untreated gingivitis and periodontitis, endodontic lesions)
- pocket depths ≥ 4 mm on adjacent teeth
- bruxism
- poor oral hygiene
- pregnant and lactating women
- taking of antibiotics in the last three months
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Due to the strong correlation between genotoxicity and carcinogenesis, it is necessary to clarify the potential genotoxic effects of titanium dental implant systems. As most dental materials release small amounts of several elements into the oral cavity, proper regulations have to guarantee that the concern from genotoxicity/mutagenicity of dental materials is annulated or at the lowest possible level. Thus, further biocompatibility records are needed in order to evaluate the comprehensive risks of these compounds. In a view of the above-mentioned data, the aim of this in vivo study is to evaluate genotoxic and cytotoxic potential of implants and gingiva formers from two different implant systems in gingival epithelial cells.
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.
Read the detailed description
Patients are divided into two groups depending on the dental implant system used in the therapy. Ankylos dental implants (Dentsplay Sirona, Charlotte, USA) are used in the first group of patients and Dentium SuperLine (Dentium Co., Seoul, Korea) in the second group.
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
- Genotoxicity
- Being tested
- implant placement, gingiva former placement, Collecting gingival epithelial cellsusing the swab technique
- Keywords
- implantology, genotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implant placementProcedure or surgery
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 placementProcedure or surgery
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 techniqueDiagnostic test
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).
| Study group | Role | What they receive |
|---|---|---|
| Ankylos dental implant group | Active comparator | 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. Receives: Procedure: implant placement; Procedure: gingiva former placement; Diagnostic Test: Collecting gingival epithelial cellsusing the swab technique |
| Dentium SuperLine implant group | Active comparator | 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-. Receives: Procedure: implant placement; Procedure: gingiva former placement; Diagnostic Test: Collecting gingival epithelial cellsusing the swab technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cytotoxic and/or genotoxic
Evaluation of the cytotoxic and genotoxic alterations in gingival epithelial cells after application of titanium-based dental implant system
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start10 Mar 2020
- Primary completion20 Mar 2021 (estimated)
- Study completion25 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for GenotoxicityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daniel Jerković
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Daniel Jerković, University of Zagreb
- Investigators
- Daniel Jerkovic, DMD, Principal investigator, University of Split, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04540991
- Sponsor's protocol ID
- 003-08/20-03/0005
- Status last verified
- Sep 2020
- First submitted
- 1 Sep 2020
- Last updated
- 7 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Piraccini BM, Urciuoli B, Starace M, Tosti A, Balestri R. Yellow nail syndrome: clinical experience in a series of 21 patients. J Dtsch Dermatol Ges. 2014 Feb;12(2):131-7. doi: 10.1111/ddg.12216. Epub 2013 Oct 18.
PubMed 24134631Berglund 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.
PubMed 20809268Sidambe AT. Biocompatibility of Advanced Manufactured Titanium Implants-A Review. Materials (Basel). 2014 Dec 19;7(12):8168-8188. doi: 10.3390/ma7128168.
PubMed 28788296Maloney WJ, Smith RL, Castro F, Schurman DJ. Fibroblast response to metallic debris in vitro. Enzyme induction cell proliferation, and toxicity. J Bone Joint Surg Am. 1993 Jun;75(6):835-44. doi: 10.2106/00004623-199306000-00005.
PubMed 8314824Wang JJ, Sanderson BJ, Wang H. Cyto- and genotoxicity of ultrafine TiO2 particles in cultured human lymphoblastoid cells. Mutat Res. 2007 Apr 2;628(2):99-106. doi: 10.1016/j.mrgentox.2006.12.003. Epub 2006 Dec 15.
PubMed 17223607Okuda-Shimazaki J, Takaku S, Kanehira K, Sonezaki S, Taniguchi A. Effects of titanium dioxide nanoparticle aggregate size on gene expression. Int J Mol Sci. 2010 Jun 7;11(6):2383-92. doi: 10.3390/ijms11062383.
PubMed 20640159Camacho-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.
PubMed 24131612Karahalil 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.
PubMed 24189049de 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.
PubMed 30025002Makihira 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.
PubMed 20682337Harris 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.
PubMed 11769832Souza 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.
PubMed 16632764Superline | 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
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genotoxicity Assessment of Dental Implants in Gingival Epithelial Cells
- ClinicalTrials.gov ID
- NCT04540991
- Acronym / sponsor ID
- 003-08/20-03/0005
- Conditions
- Genotoxicity
- Keywords
- implantology, genotoxicity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Daniel JerkovićUniversity, hospital or other
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- 20 Mar 2021 (estimated)
- Study completion
- 25 Apr 2022 (estimated)
- First posted
- 7 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Due to the strong correlation between genotoxicity and carcinogenesis, it is necessary to clarify the potential genotoxic effects of titanium dental implant systems. As most dental materials release small amounts of several elements into the oral cavity, proper regulations have to guarantee that the concern from genotoxicity/mutagenicity of dental materials is annulated or at the lowest possible level. Thus, further biocompatibility records are needed in order to evaluate the comprehensive risks of these compounds. In a view of the above-mentioned data, the aim of this in vivo study is to evaluate genotoxic and cytotoxic potential of implants and gingiva formers from two different implant systems in gingival epithelial cells.
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.
Detailed description
Patients are divided into two groups depending on the dental implant system used in the therapy. Ankylos dental implants (Dentsplay Sirona, Charlotte, USA) are used in the first group of patients and Dentium SuperLine (Dentium Co., Seoul, Korea) in the second group.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ankylos dental implant group | Active comparator | Procedure: implant placement, Procedure: gingiva former placement, Diagnostic Test: Collecting gingival epithelial cellsusing the swab techniquePatients 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. |
| Dentium SuperLine implant group | Active comparator | Procedure: implant placement, Procedure: gingiva former placement, Diagnostic Test: Collecting gingival epithelial cellsusing the swab techniquePatients 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-. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- absence of a single tooth in the mandibular molar or premolar region
- 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
Key exclusion criteria (10 listed)
- presence of systemic disease (e.g. uncontrolled diabetes, oral mucosal diseases, untreated gingivitis and periodontitis, endodontic lesions)
- pocket depths ≥ 4 mm on adjacent teeth
- bruxism
- poor oral hygiene
- pregnant and lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| implant placementThe 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. | Procedure or surgery | Ankylos dental implant group, Dentium SuperLine implant group |
| gingiva former placementGingiva 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. | Procedure or surgery | Ankylos dental implant group, Dentium SuperLine implant group |
| Collecting gingival epithelial cellsusing the swab techniqueSamples 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). | Diagnostic test | Ankylos dental implant group, Dentium SuperLine implant group |
Primary outcome
Cytotoxic and/or genotoxic
Time frame: 1 year
Evaluation of the cytotoxic and genotoxic alterations in gingival epithelial cells after application of titanium-based dental implant system
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2020.
- Background: PubMed 24134631Piraccini BM, Urciuoli B, Starace M, Tosti A, Balestri R. Yellow nail syndrome: clinical experience in a series of 21 patients. J Dtsch Dermatol Ges. 2014 Feb;12(2):131-7. doi: 10.1111/ddg.12216. Epub 2013 Oct 18.
- Background: PubMed 20809268Berglund 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.
- Background: PubMed 28788296Sidambe AT. Biocompatibility of Advanced Manufactured Titanium Implants-A Review. Materials (Basel). 2014 Dec 19;7(12):8168-8188. doi: 10.3390/ma7128168.
- Background: PubMed 8314824Maloney WJ, Smith RL, Castro F, Schurman DJ. Fibroblast response to metallic debris in vitro. Enzyme induction cell proliferation, and toxicity. J Bone Joint Surg Am. 1993 Jun;75(6):835-44. doi: 10.2106/00004623-199306000-00005.
- Background: PubMed 17223607Wang JJ, Sanderson BJ, Wang H. Cyto- and genotoxicity of ultrafine TiO2 particles in cultured human lymphoblastoid cells. Mutat Res. 2007 Apr 2;628(2):99-106. doi: 10.1016/j.mrgentox.2006.12.003. Epub 2006 Dec 15.
- Background: PubMed 20640159Okuda-Shimazaki J, Takaku S, Kanehira K, Sonezaki S, Taniguchi A. Effects of titanium dioxide nanoparticle aggregate size on gene expression. Int J Mol Sci. 2010 Jun 7;11(6):2383-92. doi: 10.3390/ijms11062383.
- Background: PubMed 24131612Camacho-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.
- Background: PubMed 24189049Karahalil 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.
- Background: PubMed 30025002de 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.
- Background: PubMed 20682337Makihira 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.
- Background: PubMed 11769832Harris 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.
- BackgroundSouza 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.
- Individual participant dataSharing planned: Undecided
Related trials for Genotoxicity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Jerkovic, DMD principal investigator
University of Split, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing implant placement, gingiva former placement and Collecting gingival epithelial cellsusing the swab technique in people with Genotoxicity, run by Daniel Jerković at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cytotoxic and/or genotoxic (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04540991, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2020.